FOOD AND DRUGDrug Any substance (other than food) that is used to prevent, diagnose, treat, or relieve symptoms of a disease or abnormal condition. Drugs can also affect how the brain and the rest of the bodywork and cause changes in mood, awareness, thoughts, feelings, or behavior. Some types of drugs, such as opioids, may be abused or lead to addiction. Apart from management Allopathic drugs never cure any disease. ADMINISTRATION MODERIZATION ACT OF 1997
Public LawLaw Positive command of sovereign or divine. One can be ruled either by a Statute, a Statue, or a Statement. Legislation is the rule-making process by a political or religious organisation. Physics governs natural law. Logical thinking is a sign of a healthy brain function. Dharma is eternal for Sanatanis. 105-115
105th Congress
An Act
To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices, and biological products, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CONTENTS.
(a) Short Title.–This Act may be cited as the “Food and Drug Administration Modernization Act of 1997”.
(b) References.–Except as otherwise specified, whenever in this Act an amendment or repeal is expressed in terms of an amendment to or a repeal of a section or other provision, the reference shall be considered to be made to that section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(c) Table of Contents.–The table of contents for this Act is as follows:
Sec. 1. Short title; references; table of contents.
Sec. 2. Definitions.
TITLE I–IMPROVING REGULATION OF DRUGS
Subtitle A–Fees Relating to Drugs
Sec. 101. Findings.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Annual reports.
Sec. 105. Savings.
Sec. 106. Effective date.
Sec. 107. Termination of effectiveness.
Subtitle B–Other Improvements
Sec. 111. Pediatric studies of drugs.
Sec. 112. Expediting study and approval of fast track drugs.
Sec. 113. Information program on clinical trials for serious or life-threatening diseases.
Sec. 114. Health care economic information.
Sec. 115. Clinical investigations.
Sec. 116. Manufacturing changes for drugs.
Sec. 117. Streamlining clinical research on drugs.
Sec. 118. Data requirements for drugs and biologics.
Sec. 119. Content and review of applications.
Sec. 120. Scientific advisory panels.
Sec. 121. Positron emission tomography.
Sec. 122. Requirements for radiopharmaceuticals.
Sec. 123. Modernization of regulation.
Sec. 124. Pilot and small scale manufacture.
Sec. 125. Insulin and antibiotics.
Sec. 126. Elimination of certain labeling requirements.
Sec. 127. Application of Federal law to practice of pharmacy compounding.
Sec. 128. Reauthorization of clinical pharmacology program.
Sec. 129. Regulations for sunscreen products.
Sec. 130. Reports of postmarketing approval studies.
Sec. 131. Notification of discontinuance of a life saving product.
TITLE II–IMPROVING REGULATION OF DEVICES
Sec. 201. Investigational device exemptions.
Sec. 202. Special review for certain devices.
Sec. 203. Expanding humanitarian use of devices.
Sec. 204. Device standards.
Sec. 205. Scope of review; collaborative determinations of device data requirements.
Sec. 206. Premarket notification.
Sec. 207. Evaluation of automatic class III designation.
Sec. 208. Classification panels.
Sec. 209. Certainty of review timeframes; collaborative review process.
Sec. 210. Accreditation of persons for review of premarket notification reports.
Sec. 211. Device tracking.
Sec. 212. Postmarket surveillance.
Sec. 213. Reports.
Sec. 214. Practice of medicineMedicine Refers to the practices and procedures used for the prevention, treatment, or relief of symptoms of diseases or abnormal conditions. This term may also refer to a legal drug used for the same purpose..
Sec. 215. Noninvasive blood glucose meter.
Sec. 216. Use of data relating to premarket approval; product development protocol.
Sec. 217. Clarification of the number of required clinical investigations for approval.
TITLE III–IMPROVING REGULATION OF FOOD
Sec. 301. Flexibility for regulations regarding claims.
Sec. 302. Petitions for claims.
Sec. 303. Health claims for food products.
Sec. 304. Nutrient content claims.
Sec. 305. Referral statements.
Sec. 306. Disclosure of irradiation.
Sec. 307. Irradiation petition.
Sec. 308. Glass and ceramic ware.
Sec. 309. Food contact substances.
TITLE IV–GENERAL PROVISIONS
Sec. 401. Dissemination of information on new uses.
Sec. 402. Expanded access to investigational therapies and diagnostics.
Sec. 403. Approval of supplemental applications for approved products.
Sec. 404. Dispute resolution.
Sec. 405. Informal agency statements.
Sec. 406. Food and Drug Administration mission and annual report.
Sec. 407. Information system.
Sec. 408. Education and training.
Sec. 409. Centers for education and research on therapeutics.
Sec. 410. Mutual recognition agreements and global harmonization.
Sec. 411. Environmental impact review.
Sec. 412. National uniformity for nonprescription drugs and cosmetics.
Sec. 413. Food and Drug Administration study of mercury compounds in drugs and food.
Sec. 414. Interagency collaboration.
Sec. 415. Contracts for expert review.
Sec. 416. Product classification.
Sec. 417. Registration of foreign establishments.
Sec. 418. Clarification of seizure authority.
Sec. 419. Interstate commerce.
Sec. 420. Safety report disclaimers.
Sec. 421. Labeling and advertising regarding compliance with statutory requirements.
Sec. 422. Rule of construction.
TITLE V–EFFECTIVE DATE
Sec. 501. Effective date.
SEC. 2. DEFINITIONS.
In this Act, the terms “drug”, “device”, “food”, and “dietary supplement” have the meaning given such terms in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
TITLE I–IMPROVING REGULATION OF DRUGS
Subtitle A–Fees Relating to Drugs
SEC. 101. FINDINGS.
Congress finds that–
(1) prompt approval of safe and effective new drugs and
other therapies is critical to the improvement of the public
health so that patients may enjoy the benefits provided by these
therapies to treat and prevent illness and disease;
(2) the public health will be served by making additional
funds available for the purpose of augmenting the resources of
the Food and Drug Administration that are devoted to the process
for review of human drug applications;
(3) the provisions added by the Prescription Drug User Fee
Act of 1992 have been successful in substantially reducing
review times for human drug applications and should be–
(A) reauthorized for an additional 5 years, with
certain technical improvements; and
(B) carried out by the Food and Drug Administration
with new commitments to implement more ambitious and
comprehensive improvements in regulatory processes of
the Food and Drug Administration; and
(4) the fees authorized by amendments made in this subtitle
will be dedicated toward expediting the drug development process
and the review of human drug applications as set forth in the
goals identified, for purposes of part 2 of subchapter C of
chapter VII of the Federal Food, Drug, and Cosmetic Act, in the
letters from the Secretary of Health and Human Services to the
chairman of the Committee on Commerce of the House of
Representatives and the chairman of the Committee on Labor and
Human Resources of the Senate, as set forth in the Congressional Record.
SEC. 102. DEFINITIONS.
Section 735 (21 U.S.C. 379g) is amended–
(1) in the second sentence of paragraph (1)–
(A) by striking “Service Act, and” and inserting
“Service Act,”; and
(B) by striking “September 1, 1992.” and inserting
the following: “September 1, 1992, does not include an
application for a licensure of a biological product for
further manufacturing use only, and does not include an
application or supplement submitted by a State or
Federal Government entity for a drug that is not
distributed commercially. Such term does include an
application for licensure, as described in subparagraph
(D), of a large volume biological product intended for
single dose injection for intravenous use or
infusion.”;
(2) in the second sentence of paragraph (3)–
(A) by striking “Service Act, and” and inserting
“Service Act,”; and
(B) by striking “September 1, 1992.” and inserting
the following: “September 1, 1992, does not include a biological product that is licensed for further
manufacturing use only, and does not include a drug that
is not distributed commercially and is the subject of an
application or supplement submitted by a State or
Federal Government entity. Such term does include a
large volume biological product intended for single dose
injection for intravenous use or infusion.”;
(3) in paragraph (4), by striking “without” and inserting
“without substantial”;
(4) by amending the first sentence of paragraph (5) to read
as follows:
“(5) The term `prescription drug establishment’ means a
foreign or domestic place of business which is at one general
physical location consisting of one or more buildings all of
which are within five miles of each other and at which one or
more prescription drug products are manufactured in final dosage form.”;
(5) in paragraph (7)(A)–
(A) by striking “employees under contractContract An agreement enforceable by law is a contract. All agreements are contracts if they are made by the free consent of parties competent to contract, for a lawful consideration and with a lawful object, and are not hereby expressly declared to be void. Indian Contract Act.” and all
that follows through “Administration,” the second timeTime Where any expression of it occurs in any Rules, or any judgment, order or direction, and whenever the doing or not doing of anything at a certain time of the day or night or during a certain part of the day or night has an effect in law, that time is, unless it is otherwise specifically stated, held to be standard time as used in a particular country or state. (In Physics, time and Space never exist actually-“quantum entanglement”)
it occurs and inserting “contractors of the Food and
Drug Administration,”; and
(B) by striking “and committees,” and inserting “and committees and to contracts with such contractors,”;
(6) in paragraph (8)–
(A) in subparagraph (A)–
(i) by striking “August of ” and inserting
“April of ”; and
(ii) by striking “August 1992” and inserting
“April 1997”; and
(B) in subparagraph (B)–
(i) by striking “section 254(d)” and
inserting “section 254(c)”;
(ii) by striking “1992” and inserting
“1997”; and
(iii) by striking “102d Congress, 2d
Session” and inserting “105th Congress, 1st
Session”; and
(7) by adding at the end the following:
“(9) The term `affiliate’ means a business entity that has
a relationship with a second business entity if, directly or
indirectly–
“(A) one business entity controls, or has the power
to control, the other business entity; or
“(B) a third party controls, or has power to
control, both of the business entities.”.
SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.
(a) Types of Fees.–Section 736(a) (21 U.S.C. 379h(a)) is amended–
(1) by striking “Beginning in fiscal year 1993” and
inserting “Beginning in fiscal year 1998”;
(2) in paragraph (1)–
(A) by striking subparagraph (B) and inserting the following:
“(B) Payment.–The fee required by subparagraph (A)
shall be due upon submission of the application or
supplement.”;
(B) in subparagraph (D)–
(i) in the subparagraph heading, by striking
“not accepted” and inserting “refused”;
(ii) by striking “50 percent” and inserting
“75 percent”;
(iii) by striking “subparagraph (B)(i)” and
inserting “subparagraph (B)”; and
(iv) by striking “not accepted” and
inserting “refused”; and
(C) by adding at the end the following:
“(E) Exception for designated orphan drug or indication.–A human drug application for a prescription
drug product that has been designated as a drug for a
rare disease or condition pursuant to section 526 shall
not be subject to a fee under subparagraph (A), unless
the human drug application includes an indication for
other than a rare disease or condition. A supplement
proposing to include a new indication for a rare disease
or condition in a human drug application shall not be
subject to a fee under subparagraph (A), if the drug has
been designated pursuant to section 526 as a drug for a
rare disease or condition with regard to the indication
proposed in such supplement.
“(F) Exception for supplements for pediatric
indications.–A supplement to a human drug application
proposing to include a new indication for use in
pediatric populations shall not be assessed a fee under
subparagraph (A).
“(G) Refund of fee if application withdrawn.–If an
application or supplement is withdrawn after the
application or supplement was filed, the Secretary may
refund the fee or a portion of the fee if no substantial
work was performed on the application or supplement
after the application or supplement was filed. The
Secretary shall have the sole discretion to refund a fee
or a portion of the fee under this subparagraph. A
determination by the Secretary concerning a refund under
this paragraph shall not be reviewable.”;
(3) by striking paragraph (2) and inserting the following:
“(2) Prescription drug establishment fee.–
“(A) In general.–Except as provided in
subparagraph (B), each person that–
“(i) is named as the applicant in a human
drug application; and
“(ii) after September 1, 1992, had pending
before the Secretary a human drug application or
supplement,
shall be assessed an annual fee established in
subsection (b) for each prescription drug establishment
listed in its approved human drug application as an
establishment that manufactures the prescription drug
product named in the application. The annual
establishment fee shall be assessed in each fiscal year
in which the prescription drug product named in the
application is assessed a fee under paragraph (3) unless
the prescription drug establishment listed in the
application does not engage in the manufacture of the
prescription drug product during the fiscal year. The
establishment fee shall be payable on or before January
31 of each year. Each such establishment shall be assessed only one fee per establishment, notwithstanding the
number of prescription drug products manufactured at the
establishment. In the event an establishment is listed
in a human drug application by more than one applicant,
the establishment fee for the fiscal year shall be
divided equally and assessed among the applicants whose
prescription drug products are manufactured by the
establishment during the fiscal year and assessed
product fees under paragraph (3).
“(B) Exception.–If, during the fiscal year, an
applicant initiates or causes to be initiated the
manufacture of a prescription drug product at an
establishment listed in its human drug application–
“(i) that did not manufacture the product in
the previous fiscal year; and
“(ii) for which the full establishment fee
has been assessed in the fiscal year at a time
before manufacture of the prescription drug
product was begun;
the applicant will not be assessed a share of the
establishment fee for the fiscal year in which the
manufacture of the product began.”; and
(4) in paragraph (3)–
(A) in subparagraph (A)–
(i) in clause (i), by striking “is listed”
and inserting “has been submitted for listing”;and
(ii) by striking “Such fee shall be payable”
and all that follows through “section 510.” and
inserting the following: “Such fee shall be
payable for the fiscal year in which the product
is first submitted for listing under section 510,
or is submitted for relisting under section 510 if
the product has been withdrawn from listing and
relisted. After such fee is paid for that fiscal
year, such fee shall be payable on or before
January 31 of each year. Such fee shall be paid
only once for each product for a fiscal year in
which the fee is payable.”; and
(B) in subparagraph (B), by striking “505(j).” and
inserting the following: “505(j), under an abbreviated
application filed under section 507 (as in effect on the
day before the date of enactment of the Food and Drug
Administration Modernization Act of 1997), or under an
abbreviated new drug application pursuant to regulations
in effect prior to the implementation of the Drug Price
Competition and Patent Term Restoration Act of 1984.”.
(b) Fee Amounts.–Section 736(b) (21 U.S.C. 379h(b)) is amended to
read as follows:
“(b) Fee Amounts.–Except as provided in subsections (c), (d), (f),
and (g), the fees required under subsection (a) shall be determined and
assessed as follows:
“(1) Application and supplement fees.–
“(A) Full fees.–The application fee under
subsection (a)(1)(A)(i) shall be $250,704 in fiscal year
1998, $256,338 in each of fiscal years 1999 and 2000,
$267,606 in fiscal year 2001, and $258,451 in fiscal
year 2002.
“(B) Other fees.–The fee under subsection
(a)(1)(A)(ii) shall be $125,352 in fiscal year 1998,
$128,169
in each of fiscal years 1999 and 2000, $133,803 in
fiscal year 2001, and $129,226 in fiscal year 2002.
“(2) Total fee revenues for establishment fees.–The total
fee revenues to be collected in establishment fees under
subsection (a)(2) shall be $35,600,000 in fiscal year 1998,
$36,400,000 in each of fiscal years 1999 and 2000, $38,000,000
in fiscal year 2001, and $36,700,000 in fiscal year 2002.
“(3) Total fee revenues for product fees.–The total fee
revenues to be collected in product fees under subsection (a)(3)
in a fiscal year shall be equal to the total fee revenues
collected in establishment fees under subsection (a)(2) in that
fiscal year.”.
(c) Increases and Adjustments.–Section 736(c) (21 U.S.C. 379h(c))
is amended–
(1) in the subsection heading, by striking “Increases
and”;
(2) in paragraph (1)–
(A) by striking “(1) Revenue” and all that follows
through “increased by the Secretary” and inserting the
following: “(1) Inflation adjustment.–The fees and
total fee revenues established in subsection (b) shall
be adjusted by the Secretary”;
(B) in subparagraph (A), by striking “increase”
and inserting “change”;
(C) in subparagraph (B), by striking “increase”
and inserting “change”; and
(D) by adding at the end the following flush
sentence:
“The adjustment made each fiscal year by this subsection will
be added on a compounded basis to the sum of all adjustments
made each fiscal year after fiscal year 1997 under this
subsection.”;
(3) in paragraph (2), by striking “October 1, 1992,” and
all that follows through “such schedule.” and inserting the
following: “September 30, 1997, adjust the establishment and
product fees described in subsection (b) for the fiscal year in
which the adjustment occurs so that the revenues collected from
each of the categories of fees described in paragraphs (2) and
(3) of subsection (b) shall be set to be equal to the revenues
collected from the category of application and supplement fees
described in paragraph (1) of subsection (b).”; and
(4) in paragraph (3), by striking “paragraph (2)” and
inserting “this subsection”.
(d) Fee Waiver or Reduction.–Section 736(d) (21 U.S.C. 379h(d)) is
amended–
(1) by redesignating paragraphs (1), (2), (3), and (4) as
subparagraphs (A), (B), (C), and (D), respectively and indenting
appropriately;
(2) by striking “The Secretary shall grant a” and all that
follows through “finds that–” and inserting the following:
“(1) In general.–The Secretary shall grant a waiver from
or a reduction of one or more fees assessed under subsection (a)
where the Secretary finds that–”;
(3) in subparagraph (C) (as so redesignated in paragraph
(1)), by striking “, or” and inserting a comma;
(4) in subparagraph (D) (as so redesignated in paragraph
(1)), by striking the period and inserting “, or”;
(5) by inserting after subparagraph (D) (as so redesignated
in paragraph (1)) the following:
[[Page 111 STAT. 2303]]
“(E) the applicant involved is a small business
submitting its first human drug application to the
Secretary for review.”; and
(6) by striking “In making the finding in paragraph (3),”
and all that follows through “standard costsCosts Subject to any written law, costs are at the discretion of the Court, and the Court has the power to determine all issues relating to the costs of or incidental to all proceedings, including by whom and to what extent the costs are to be paid, at any stage of the proceedings or after the conclusion of the proceedings. Generally “Costs” includes charges, disbursements, expenses, fees, and remuneration. Costs in any matter are payable from the date of the order of the Court unless the parties otherwise agree. The costs of a third-party funding contract are not recoverable as part of the costs of, or costs..” and inserting
the following:
“(2) Use of standard costs.–In making the finding in
paragraph (1)(C), the Secretary may use standard costs.
“(3) Rules relating to small businesses.–
“(A) Definition.–In paragraph (1)(E), the term
`small business’ means an entity that has fewer than 500
employees, including employees of affiliates.
“(B) Waiver of application fee.–The Secretary
shall waive under paragraph (1)(E) the application fee
for the first human drug application that a small
business or its affiliate submits to the Secretary for
review. After a small business or its affiliate is
granted such a waiver, the small business or its
affiliate shall pay–
“(i) application fees for all subsequent
human drug applications submitted to the Secretary
for review in the same manner as an entity that
does not qualify as a small business; and
“(ii) all supplement fees for all supplements
to human drug applications submitted to the
Secretary for review in the same manner as an
entity that does not qualify as a small
business.”.
(e) Assessment of Fees.–Section 736(f)(1) (21 U.S.C. 379h(f)(1)) is
amended–
(1) by striking “fiscal year 1993” and inserting “fiscal
year 1997”; and
(2) by striking “fiscal year 1992” and inserting “fiscal
year 1997 (excluding the amount of fees appropriated for such
fiscal year)”.
(f) Crediting and Availability of Fees.–Section 736(g) (21 U.S.C.
379h(g)) is amended–
(1) in paragraph (1), by adding at the end the following:
“Such sums as may be necessary may be transferred from the Food
and Drug Administration salaries and expenses appropriation
account without fiscal year limitation to such appropriation
account for salaries and expenses with such fiscal year
limitation. The sums transferred shall be available solely for
the process for the review of human drug applications.”;
(2) in paragraph (2)–
(A) in subparagraph (A), by striking “Acts” and
inserting “Acts, or otherwise made available for
obligation,”; and
(B) in subparagraph (B), by striking “over such
costs for fiscal year 1992” and inserting “over such
costs, excluding costs paid from fees collected under
this section, for fiscal year 1997”; and
(3) by striking paragraph (3) and inserting the following:
“(3) Authorization of appropriations.–There are authorized
to be appropriated for fees under this section–
“(A) $106,800,000 for fiscal year 1998;
“(B) $109,200,000 for fiscal year 1999;
“(C) $109,200,000 for fiscal year 2000;
“(D) $114,000,000 for fiscal year 2001; and
“(E) $110,100,000 for fiscal year 2002,
[[Page 111 STAT. 2304]]
as adjusted to reflect adjustments in the total fee revenues
made under this section and changes in the total amounts
collected by application, supplement, establishment, and product
fees.
“(4) Offset.–Any amount of fees collected for a fiscal
year under this section that exceeds the amount of fees
specified in appropriation Acts for such fiscal year shall be
credited to the appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall be
subtracted from the amount of fees that would otherwise be
authorized to be collected under this section pursuant to
appropriation Acts for a subsequent fiscal year.”.
(g) Requirement for Written Requests for Waivers, Reductions, and
Refunds.–Section 736 (21 U.S.C. 379h) is amended–
(1) by redesignating subsection (i) as subsection (j); and
(2) by inserting after subsection (h) the following:
“(i) Written Requests for Waivers, Reductions, and Refunds.–To
qualify for consideration for a waiver or reduction under subsection
(d), or for a refund of any fee collected in accordance with subsection
(a), a person shall submit to the Secretary a written request for such
waiver, reduction, or refund not later than 180 days after such fee is
due.”.
(h) Special Rule for Waivers and
Refunds.–Any requests for waivers or refunds for fees assessed under
section 736 of the Federal Food, Drug, and Cosmetic Act (42 U.S.C. 379h)
prior to the date of enactment of this Act shall be submitted in writing
to the Secretary of Health and Human Services within 1 year after the
date of enactment of this Act. Any requests for waivers or refunds
pertaining to a fee for a human drug application or supplement accepted
for filing prior to October 1, 1997 or to a product or establishment fee
required by such Act for a fiscal year prior to fiscal year 1998, shall
be evaluated according to the terms of the Prescription Drug User Fee
Act of 1992 (as in effect on September 30, 1997) and part 2 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(as in effect on September 30, 1997). The term “person” in such Acts
shall continue to include an affiliate thereof.
SEC. 104. ANNUAL REPORTS.
(a) Performance Report.–Beginning with fiscal year 1998, not later
than 60 days after the end of each fiscal year during which fees are
collected under part 2 of subchapter C of chapter VII of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary of
Health and Human Services shall prepare and submit to the Committee on
Commerce of the House of Representatives and the Committee on Labor and
Human Resources of the Senate a report concerning the progress of the
Food and Drug Administration in achieving the goals identified in the
letters described in section 101(4) during such fiscal year and the
future plans of the Food and Drug Administration for meeting the goals.
(b) Fiscal Report.–Beginning with fiscal year 1998, not later than
120 days after the end of each fiscal year during which fees are
collected under the part described in subsection (a), the Secretary of
Health and Human Services shall prepare and submit to the Committee on
Commerce of the House of Representatives and the Committee on Labor and
Human Resources of the Senate
[[Page 111 STAT. 2305]]
a report on the implementation of the authority for such fees during
such fiscal year and the use, by the Food and Drug Administration, of
the fees collected during such fiscal year for which the report is made.
<> SEC. 105. SAVINGS.
Notwithstanding section 105 of the Prescription Drug User Fee Act of
1992, the Secretary shall retain the authority to assess and collect any
fee required by part 2 of subchapter C of chapter VII of the Federal
Food, Drug, and Cosmetic Act for a human drug application or supplement
accepted for filing prior to October 1, 1997, and to assess and collect
any product or establishment fee required by such Act for a fiscal year
prior to fiscal year 1998.
<> SEC. 106. EFFECTIVE DATE.
The amendments made by this subtitle shall take effect October 1,
1997.
<> SEC. 107. TERMINATION OF EFFECTIVENESS.
The amendments made by sections 102 and 103 cease to be effective
October 1, 2002, and section 104 ceases to be effective 120 days after
such date.
Subtitle B–Other Improvements
SEC. 111. PEDIATRIC STUDIES OF DRUGS.
Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after
section 505 the following:
<> “SEC. 505A. PEDIATRIC STUDIES OF DRUGS.
“(a) Market Exclusivity for New Drugs.–If, prior to approval of an
application that is submitted under section 505(b)(1), the Secretary
determines that information relating to the use of a new drug in the
pediatric population may produce health benefits in that population, the
Secretary makes a written request for pediatric studies (which shall
include a timeframe for completing such studies), and such studies are
completed within any such timeframe and the reports thereof submitted in
accordance with subsection (d)(2) or accepted in accordance with
subsection (d)(3)–
“(1)(A)(i) the period referred to in subsection
(c)(3)(D)(ii) of section 505, and in subsection (j)(4)(D)(ii) of
such section, is deemed to be five years and six months rather
than five years, and the references in subsections (c)(3)(D)(ii)
and (j)(4)(D)(ii) of such section to four years, to forty-eight
months, and to seven and one-half years are deemed to be four
and one-half years, fifty-four months, and eight years,
respectively; or
“(ii) the period referred to in clauses (iii) and (iv) of
subsection (c)(3)(D) of such section, and in clauses (iii) and
(iv) of subsection (j)(4)(D) of such section, is deemed to be
three years and six months rather than three years; and
“(B) if the drug is designated under section 526 for a rare
disease or condition, the period referred to in section 527(a)
is deemed to be seven years and six months rather than seven
years; and
“(2)(A) if the drug is the subject of–
[[Page 111 STAT. 2306]]
“(i) a listed patent for which a certification has
been submitted under subsection (b)(2)(A)(ii) or
(j)(2)(A)(vii)(II) of section 505 and for which
pediatric studies were submitted prior to the expiration
of the patent (including any patent extensions); or
“(ii) a listed patent for which a certification has
been submitted under subsections (b)(2)(A)(iii) or
(j)(2)(A)(vii)(III) of section 505,
the period during which an application may not be approved under
section 505(c)(3) or section 505(j)(4)(B) shall be extended by a
period of six months after the date the patent expires
(including any patent extensions); or
“(B) if the drug is the subject of a listed patent for
which a certification has been submitted under subsection
(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the
patent infringement litigation resulting from the certification
the court determines that the patent is valid and would be
infringed, the period during which an application may not be
approved under section 505(c)(3) or section 505(j)(4)(B) shall
be extended by a period of six months after the date the patent
expires (including any patent extensions).
“(b) Secretary To Develop List of Drugs for Which Additional
Pediatric Information May Be Beneficial.–Not later than 180 days after
the date of enactment of the Food and Drug Administration Modernization
Act of 1997, the Secretary, after consultation with experts in pediatric
research shall develop, prioritize, and publish an initial list of
approved drugs for which additional pediatric information may produce
health benefits in the pediatric population. The Secretary shall
annually update the list.
“(c) Market Exclusivity for Already-Marketed Drugs.–If the
Secretary makes a written request to the holder of an approved
application under section 505(b)(1) for pediatric studies (which shall
include a timeframe for completing such studies) concerning a drug
identified in the list described in subsection (b), the holder agrees to
the request, the studies are completed within any such timeframe, and
the reports thereof are submitted in accordance with subsection (d)(2)
or accepted in accordance with subsection (d)(3)–
“(1)(A)(i) the period referred to in subsection
(c)(3)(D)(ii) of section 505, and in subsection (j)(4)(D)(ii) of
such section, is deemed to be five years and six months rather
than five years, and the references in subsections (c)(3)(D)(ii)
and (j)(4)(D)(ii) of such section to four years, to forty-eight
months, and to seven and one-half years are deemed to be four
and one-half years, fifty-four months, and eight years,
respectively; or
“(ii) the period referred to in clauses (iii) and (iv) of
subsection (c)(3)(D) of such section, and in clauses (iii) and
(iv) of subsection (j)(4)(D) of such section, is deemed to be
three years and six months rather than three years; and
“(B) if the drug is designated under section 526 for a rare
disease or condition, the period referred to in section 527(a)
is deemed to be seven years and six months rather than seven
years; and
“(2)(A) if the drug is the subject of–
“(i) a listed patent for which a certification has
been submitted under subsection (b)(2)(A)(ii) or
(j)(2)(A)(vii)(II)
[[Page 111 STAT. 2307]]
of section 505 and for which pediatric studies were
submitted prior to the expiration of the patent
(including any patent extensions); or
“(ii) a listed patent for which a certification has
been submitted under subsection (b)(2)(A)(iii) or
(j)(2)(A)(vii)(III) of section 505,
the period during which an application may not be approved under
section 505(c)(3) or section 505(j)(4)(B) shall be extended by a
period of six months after the date the patent expires
(including any patent extensions); or
“(B) if the drug is the subject of a listed patent for
which a certification has been submitted under subsection
(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the
patent infringement litigation resulting from the certification
the court determines that the patent is valid and would be
infringed, the period during which an application may not be
approved under section 505(c)(3) or section 505(j)(4)(B) shall
be extended by a period of six months after the date the patent
expires (including any patent extensions).
“(d) Conduct of Pediatric Studies.–
“(1) AgreementContract An agreement enforceable by law is a contract. All agreements are contracts if they are made by the free consent of parties competent to contract, for a lawful consideration and with a lawful object, and are not hereby expressly declared to be void. Indian Contract Act. for studies.–The Secretary may, pursuant to
a written request from the Secretary under subsection (a) or
(c), after consultation with–
“(A) the sponsor of an application for an
investigational new drug under section 505(i);
“(B) the sponsor of an application for a new drug
under section 505(b)(1); or
“(C) the holder of an approved application for a
drug under section 505(b)(1),
agree with the sponsor or holder for the conduct of pediatric
studies for such drug. Such agreement shall be in writing and
shall include a timeframe for such studies.
“(2) Written protocols to meet the studies requirement.–If
the sponsor or holder and the Secretary agree upon written
protocols for the studies, the studies requirement of subsection
(a) or (c) is satisfied upon the completion of the studies and
submission of the reports thereof in accordance with the
original written request and the written agreement referred to
in paragraph (1). Not later than 60 days after the submission of
the report of the studies, the Secretary shall determine if such
studies were or were not conducted in accordance with the
original written request and the written agreement and reported
in accordance with the requirements of the Secretary for filing
and so notify the sponsor or holder.
“(3) Other methods to meet the studies requirement.–If the
sponsor or holder and the Secretary have not agreed in writing
on the protocols for the studies, the studies requirement of
subsection (a) or (c) is satisfied when such studies have been
completed and the reports accepted by the Secretary. Not later
than 90 days after the submission of the reports of the studies,
the Secretary shall accept or reject such reports and so notify
the sponsor or holder. The Secretary’s only responsibility in
accepting or rejecting the reports shall be to determine, within
the 90 days, whether the studies fairly respond to the written
request, have been conducted in accordance with commonly
accepted scientific principles and protocols, and
[[Page 111 STAT. 2308]]
have been reported in accordance with the requirements of the
Secretary for filing.
“(e) Delay of Effective Date for Certain Application.–If the
Secretary determines that the acceptance or approval of an application
under section 505(b)(2) or 505(j) for a new drug may occur after
submission of reports of pediatric studies under this section, which
were submitted prior to the expiration of the patent (including any
patent extension) or the applicable period under clauses (ii) through
(iv) of section 505(c)(3)(D) or clauses (ii) through (iv) of section
505(j)(4)(D), but before the Secretary has determined whether the
requirements of subsection (d) have been satisfied, the Secretary shall
delay the acceptance or approval under section 505(b)(2) or 505(j) until
the determination under subsection (d) is made, but any such delay shall
not exceed 90 days. In the event that requirements of this section are
satisfied, the applicable six-month period under subsection (a) or (c)
shall be deemed to have been running during the period of delay.
“(f) Notice of Determinations on Studies Requirement.–The
Secretary shall publish a notice of any determination that the
requirements of subsection (d) have been met and that submissions and
approvals under subsection (b)(2) or (j) of section 505 for a drug will
be subject to the provisions of this section.
“(g) Definitions.–As used in this section, the term `pediatric
studies’ or `studies’ means at least one clinical investigationInvestigation Purpose of all investigation is to reveal the unvarnished truth. The constitutional courts are duty bound to ensure that the truth is revealed. (that,
at the Secretary’s discretion, may include pharmacokinetic studies) in
pediatric age groups in which a drug is anticipated to be used.
“(h) Limitations.–A drug to which the six-month period under
subsection (a) or (b) has already been applied–
“(1) may receive an additional six-month period under
subsection (c)(1)(A)(ii) for a supplemental application if all
other requirements under this section are satisfied, except that
such a drug may not receive any additional such period under
subsection (c)(2); and
“(2) may not receive any additional such period under
subsection (c)(1)(B).
“(i) Relationship to Regulations.–Notwithstanding any other
provision of law, if any pediatric study is required pursuant to
regulations promulgated by the Secretary and such study meets the
completeness, timeliness, and other requirements of this section, such
study shall be deemed to satisfy the requirement for market exclusivity
pursuant to this section.
“(j) Sunset.–A drug may not receive any six-month period under
subsection (a) or (c) unless the application for the drug under section
505(b)(1) is submitted on or before January 1, 2002. After January 1,
2002, a drug shall receive a six-month period under subsection (c) if–
“(1) the drug was in commercial distribution as of the date
of enactment of the Food and Drug Administration Modernization
Act of 1997;
“(2) the drug was included by the Secretary on the list
under subsection (b) as of January 1, 2002;
“(3) the Secretary determines that there is a continuing
need for information relating to the use of the drug in the
pediatric population and that the drug may provide health
benefits in that population; and
“(4) all requirements of this section are met.
[[Page 111 STAT. 2309]]
“(k) Report.–The Secretary shall conduct a study and report to
Congress not later than January 1, 2001, based on the experience under
the program established under this section. The study and report shall
examine all relevant issues, including–
“(1) the effectiveness of the program in improving
information about important pediatric uses for approved drugs;
“(2) the adequacy of the incentive provided under this
section;
“(3) the economic impact of the program on taxpayers and
consumers, including the impact of the lack of lower cost
generic drugs on patients, including on lower income patients;
and
“(4) any suggestions for modification that the Secretary
determines to be appropriate.”.
SEC. 112. EXPEDITING STUDY AND APPROVAL OF FAST TRACK DRUGS.
(a) In General.–Chapter V (21 U.S.C. 351 et seq.), as amended by
section 125, is amended by inserting before section 508 the following:
<> “SEC. 506. FAST TRACK PRODUCTS.
“(a) Designation of Drug as a Fast Track Product.–
“(1) In general.–The Secretary shall, at the request of
the sponsor of a new drug, facilitate the development and
expedite the review of such drug if it is intended for the
treatment of a serious or life-threatening condition and it
demonstrates the potential to address unmet medical needs for
such a condition. (In this section, such a drug is referred to
as a `fast track product’.)
“(2) Request for designation.–The sponsor of a new drug
may request the Secretary to designate the drug as a fast track
product. A request for the designation may be made concurrently
with, or at any time after, submission of an application for the
investigation of the drug under section 505(i) or section
351(a)(3) of the Public Health Service Act.
“(3) Designation.–Within 60 calendar days after the
receipt of a request under paragraph (2), the Secretary shall
determine whether the drug that is the subject of the request
meets the criteria described in paragraph (1). If the Secretary
finds that the drug meets the criteria, the Secretary shall
designate the drug as a fast track product and shall take such
actions as are appropriate to expedite the development and
review of the application for approval of such product.
“(b) Approval of Application for a Fast Track Product.–
“(1) In general.–The Secretary may approve an application
for approval of a fast track product under section 505(c) or
section 351 of the Public Health Service Act upon a
determination that the product has an effect on a clinical
endpoint or on a surrogate endpoint that is reasonably likely to
predict clinical benefit.
“(2) Limitation.–Approval of a fast track product under
this subsection may be subject to the requirements–
“(A) that the sponsor conduct appropriate post-
approval studies to validate the surrogate endpoint or
otherwise confirm the effect on the clinical endpoint;
and
“(B) that the sponsor submit copies of all
promotional materials related to the fast track product
during the preapproval review period and, following
approval and for such period thereafter as the Secretary
determines to be
[[Page 111 STAT. 2310]]
appropriate, at least 30 days prior to dissemination of
the materials.
“(3) Expedited withdrawal of approval.–The Secretary may
withdraw approval of a fast track product using expedited
procedures (as prescribed by the Secretary in regulations which
shall include an opportunity for an informal hearing) if–
“(A) the sponsor fails to conduct any required
post-approval study of the fast track drug with due
diligence;
“(B) a post-approval study of the fast track
product fails to verify clinical benefit of the product;
“(C) other evidenceEvidence All the means by which a matter of fact, the truth of which is submitted for investigation, is established or disproved.
Bharatiya Sakshya (Second) Adhiniyam 2023
demonstrates that the fast
track product is not safe or effective under the
conditions of use; or
“(D) the sponsor disseminates false or misleading
promotional materials with respect to the product.
“(c) Review of Incomplete Applications for Approval of a Fast Track
Product.–
“(1) In general.–If the Secretary determines, after
preliminary evaluation of clinical data submitted by the
sponsor, that a fast track product may be effective, the
Secretary shall evaluate for filing, and may commence review of
portions of, an application for the approval of the product
before the sponsor submits a complete application. The Secretary
shall commence such review only if the applicant–
“(A) provides a schedule for submission of
information necessary to make the application complete;
and
“(B) pays any fee that may be required under
section 736.
“(2) Exception.–Any time period for review of human drug
applications that has been agreed to by the Secretary and that
has been set forth in goals identified in letters of the
Secretary (relating to the use of fees collected under section
736 to expedite the drug development process and the review of
human drug applications) shall not apply to an application
submitted under paragraph (1) until the date on which the
application is complete.
“(d) Awareness Efforts.–The Secretary shall–
“(1) develop and disseminate to physicians, patient
organizations, pharmaceutical and biotechnology companies, and
other appropriate persons a description of the provisions of
this section applicable to fast track products; and
“(2) establish a program to encourage the development of
surrogate endpoints that are reasonably likely to predict
clinical benefit for serious or life-threatening conditions for
which there exist significant unmet medical needs.”.
<> (b) Guidance.–Within 1 year after the
date of enactment of this Act, the Secretary of Health and Human
Services shall issue guidance for fast track products (as defined in
section 506(a)(1) of the Federal Food, Drug, and Cosmetic Act) that
describes the policies and procedures that pertain to section 506 of
such Act.
SEC. 113. INFORMATION PROGRAM ON CLINICAL TRIALS FOR SERIOUS OR
LIFE-THREATENING DISEASES.
(a) In General.–Section 402 of the Public Health Service Act (42
U.S.C. 282) is amended–
(1) by redesignating subsections (j) and (k) as subsections
(k) and (l), respectively; and
[[Page 111 STAT. 2311]]
(2) by inserting after subsection (i) the following:
<> “(j)(1)(A) The Secretary, acting through
the Director of NIH, shall establish, maintain, and operate a data bank
of information on clinical trials for drugs for serious or life-
threatening diseases and conditions (in this subsection referred to as
the `data bank’). The activities of the data bank shall be integrated
and coordinated with related activities of other agencies of the
Department of Health and Human Services, and to the extent practicable,
coordinated with other data banks containing similar information.
“(B) The Secretary shall establish the data bank after consultation
with the Commissioner of Food and Drugs, the directors of the
appropriate agencies of the National Institutes of Health (including the
National Library of Medicine), and the Director of the Centers for
Disease Control and Prevention.
“(2) In carrying out paragraph (1), the Secretary shall collect,
catalog, store, and disseminate the information described in such
paragraph. The Secretary shall disseminate such information through
information systems, which shall include toll-free telephone
communications, available to individuals with serious or life-
threatening diseases and conditions, to other members of the public, to
health care providers, and to researchers.
“(3) The data bank shall include the following:
“(A) A registry of clinical trials (whether federally or
privately funded) of experimental treatments for serious or
life-threatening diseases and conditions under regulations
promulgated pursuant to section 505(i) of the Federal Food,
Drug, and Cosmetic Act, which provides a description of the
purpose of each experimental drug, either with the consent of
the protocol sponsor, or when a trial to test effectiveness
begins. Information provided shall consist of eligibility
criteria for participation in the clinical trials, a description
of the location of trial sites, and a point of contact for those
wanting to enroll in the trial, and shall be in a form that can
be readily understood by members of the public. Such information
shall be forwarded to the data bank by the sponsor of the trial
not later than 21 days after the approval of the protocol.
“(B) Information pertaining to experimental treatments for
serious or life-threatening diseases and conditions that may be
available–
“(i) under a treatment investigational new drug
application that has been submitted to the Secretary
under section 561(c) of the Federal Food, Drug, and
Cosmetic Act; or
“(ii) as a Group C cancerCancer Cancer is a term for a disease in which abnormal cells divide without control. Cancer cells can invade nearby tissues and can spread through the bloodstream and lymphatic system to other parts of the body.
Dictionary of Cancer.
Cancer Types: Primary Bone Cancer, Cancer in Children and Adolescents, Head and Neck Cancers, Inflammatory Breast Cancer, Paget Disease of the Breast.
There exists a possible connection between acrylamide, artificial sweeteners, fluoridated water, and Oral Contraceptives. Vitamin D and antioxidants may protect cells from the damage caused by unstable molecules known as free radicals.
drug (as defined by the
National Cancer Institute).
The data bank may also include information pertaining to the
results of clinical trials of such treatments, with the consent
of the sponsor, including information concerning potential
toxicities or adverse effects associated with the use or
administration of such experimental treatments.
“(4) The data bank shall not include information relating to an
investigation if the sponsor has provided a detailed certification to
the Secretary that disclosure of such information would substantially
interfere with the timely enrollment of subjects in the investigation,
unless the Secretary, after the receipt of the certification, provides
the sponsor with a detailed written determination that
[[Page 111 STAT. 2312]]
such disclosure would not substantially interfere with such enrollment.
<> “(5) For the purpose of
carrying out this subsection, there are authorized to be appropriated
such sums as may be necessary. Fees collected under section 736 of the
Federal Food, Drug, and Cosmetic Act shall not be used in carrying out
this subsection.”.
<> (b) Collaboration and Report.–
(1) In general.–The Secretary of Health and Human Services,
the Director of the National Institutes of Health, and the
Commissioner of Food and Drugs shall collaborate to determine
the feasibility of including device investigations within the
scope of the data bank under section 402(j) of the Public Health
Service Act.
(2) Report.–Not later than two years after the date of
enactment of this section, the Secretary of Health and Human
Services shall prepare and submit to the Committee on Labor and
Human Resources of the Senate and the Committee on Commerce of
the House of Representatives a report–
(A) of the public health need, if any, for inclusion
of device investigations within the scope of the data
bank under section 402(j) of the Public Health Service
Act;
(B) on the adverse impact, if any, on device
innovation and research in the United States if
information relating to such device investigations is
required to be publicly disclosed; and
(C) on such other issues relating to such section
402(j) as the Secretary determines to be appropriate.
SEC. 114. HEALTH CARE ECONOMIC INFORMATION.
(a) In General.–Section 502(a) (21 U.S.C. 352(a)) is amended by
adding at the end the following: “Health care economic information
provided to a formulary committee, or other similar entity, in the
course of the committee or the entity carrying out its responsibilities
for the selection of drugs for managed care or other similar
organizations, shall not be considered to be false or misleading under
this paragraph if the health care economic information directly relates
to an indication approved under section 505 or under section 351(a) of
the Public Health Service Act for such drug and is based on competent
and reliable scientific evidence. The requirements set forth in section
505(a) or in section 351(a) of the Public Health Service Act shall not
apply to health care economic information provided to such a committee
or entity in accordance with this paragraph. Information that is
relevant to the substantiation of the health care economic information
presented pursuant to this paragraph shall be made available to the
Secretary upon request. In this paragraph, the term `health care
economic information’ means any analysis that identifies, measures, or
compares the economic consequences, including the costs of the
represented health outcomes, of the use of a drug to the use of another
drug, to another health care intervention, or to no intervention.”.
<> (b) Study and Report.–The Comptroller
General of the United States shall conduct a study of the implementation
of the provisions added by the amendment made by subsection (a). Not
later than 4 years and 6 months after the date of enactment of this Act,
the Comptroller General of the United States shall prepare and submit to
Congress a report containing the findings of the study.
[[Page 111 STAT. 2313]]
SEC. 115. CLINICAL INVESTIGATIONS.
(a) Clarification of the Number of Required Clinical Investigations
for Approval.–Section 505(d) (21 U.S.C. 355(d)) is amended by adding at
the end the following: “If the Secretary determines, based on relevant
science, that data from one adequate and well-controlled clinical
investigation and confirmatory evidence (obtained prior to or after such
investigation) are sufficient to establish effectiveness, the Secretary
may consider such data and evidence to constitute substantial evidence
for purposes of the preceding sentence.”.
(b) Women and Minorities.–Section 505(b)(1) (21 U.S.C. 355(b)(1))
is amended by adding at the end the following: “The Secretary shall, in
consultation with the Director of the National Institutes of Health and
with representatives of the drug manufacturing industry, review and
develop guidance, as appropriate, on the inclusion of women and
minorities in clinical trials required by clause (A).”.
SEC. 116. MANUFACTURING CHANGES FOR DRUGS.
(a) In General.–Chapter V, as amended by section 112, is amended by
inserting after section 506 the following section:
<> “SEC. 506A. MANUFACTURING CHANGES.
“(a) In General.–With respect to a drug for which there is in
effect an approved application under section 505 or 512 or a license
under section 351 of the Public Health Service Act, a change from the
manufacturing process approved pursuant to such application or license
may be made, and the drug as made with the change may be distributed,
if–
“(1) the holder of the approved application or license
(referred to in this section as a `holder’) has validated the
effects of the change in accordance with subsection (b); and
“(2)(A) in the case of a major manufacturing change, the
holder has complied with the requirements of subsection (c); or
“(B) in the case of a change that is not a major
manufacturing change, the holder complies with the applicable
requirements of subsection (d).
“(b) Validation of Effects of Changes.–For purposes of subsection
(a)(1), a drug made with a manufacturing change (whether a major
manufacturing change or otherwise) may be distributed only if, before
distribution of the drug as so made, the holder involved validates the
effects of the change on the identity, strength, quality, purity, and
potency of the drug as the identity, strength, quality, purity, and
potency may relate to the safety or effectiveness of the drug.
“(c) Major Manufacturing Changes.–
“(1) Requirement of supplemental application.–For purposes
of subsection (a)(2)(A), a drug made with a major manufacturing
change may be distributed only if, before the distribution of
the drug as so made, the holder involved submits to the
Secretary a supplemental application for such change and the
Secretary approves the application. The application shall
contain such information as the Secretary determines to be
appropriate, and shall include the information developed under
subsection (b) by the holder in validating the effects of the
change.
[[Page 111 STAT. 2314]]
“(2) Changes qualifying as major changes.–For purposes of
subsection (a)(2)(A), a major manufacturing change is a
manufacturing change that is determined by the Secretary to have
substantial potential to adversely affect the identity,
strength, quality, purity, or potency of the drug as they may
relate to the safety or effectiveness of a drug. Such a change
includes a change that–
“(A) is made in the qualitative or quantitative
formulation of the drug involved or in the
specifications in the approved application or license
referred to in subsection (a) for the drug (unless
exempted by the Secretary by regulation or guidance from
the requirements of this subsection);
“(B) is determined by the Secretary by regulation
or guidance to require completion of an appropriate
clinical study demonstrating equivalence of the drug to
the drug as manufactured without the change; or
“(C) is another type of change determined by the
Secretary by regulation or guidance to have a
substantial potential to adversely affect the safety or
effectiveness of the drug.
“(d) Other Manufacturing Changes.–
“(1) In general.–For purposes of subsection (a)(2)(B), the
Secretary may regulate drugs made with manufacturing changes
that are not major manufacturing changes as follows:
“(A) The Secretary may in accordance with paragraph
(2) authorize holders to distribute such drugs without
submitting a supplemental application for such changes.
“(B) The Secretary may in accordance with paragraph
(3) require that, prior to the distribution of such
drugs, holders submit to the Secretary supplemental
applications for such changes.
“(C) The Secretary may establish categories of such
changes and designate categories to which subparagraph
(A) applies and categories to which subparagraph (B)
applies.
“(2) Changes not requiring supplemental application.–
“(A) Submission of report.–A holder making a
manufacturing change to which paragraph (1)(A) applies
shall submit to the Secretary a report on the change,
which shall contain such information as the Secretary
determines to be appropriate, and which shall include
the information developed under subsection (b) by the
holder in validating the effects of the change. The
report shall be submitted by such date as the Secretary
may specify.
“(B) Authority regarding annual reports.–In the
case of a holder that during a single year makes more
than one manufacturing change to which paragraph (1)(A)
applies, the Secretary may in carrying out subparagraph
(A) authorize the holder to comply with such
subparagraph by submitting a single report for the year
that provides the information required in such
subparagraph for all the changes made by the holder
during the year.
“(3) Changes requiring supplemental application.–
“(A) Submission of supplemental application.–The
supplemental application required under paragraph (1)(B)
[[Page 111 STAT. 2315]]
for a manufacturing change shall contain such
information as the Secretary determines to be
appropriate, which shall include the information
developed under subsection (b) by the holder in
validating the effects of the change.
“(B) Authority for distribution.–In the case of a
manufacturing change to which paragraph (1)(B) applies:
“(i) The holder involved may commence
distribution of the drug involved 30 days after
the Secretary receives the supplemental
application under such paragraph, unless the
Secretary notifies the holder within such 30-day
period that prior approval of the application is
required before distribution may be commenced.
“(ii) The Secretary may designate a category
of such changes for the purpose of providing that,
in the case of a change that is in such category,
the holder involved may commence distribution of
the drug involved upon the receipt by the
Secretary of a supplemental application for the
change.
“(iii) If the Secretary disapproves the
supplemental application, the Secretary may order
the manufacturer to cease the distribution of the
drugs that have been made with the manufacturing
change.”.
<> (b) Transition Rule.–The amendment
made by subsection (a) takes effect upon the effective date of
regulations promulgated by the Secretary of Health and Human Services to
implement such amendment, or upon the expiration of the 24-month period
beginning on the date of the enactment of this Act, whichever occurs
first.
SEC. 117. STREAMLINING CLINICAL RESEARCH ON DRUGS.
Section 505(i) (21 U.S.C. 355(i)) is amended–
(1) by redesignating paragraphs (1) through (3) as
subparagraphs (A) through (C), respectively;
(2) by inserting “(1)” after “(i)”;
(3) by striking the last two sentences; and
(4) by inserting after paragraph (1) (as designated by
paragraph (2) of this section) the following new paragraphs:
“(2) Subject to paragraph (3), a clinical investigation of a new
drug may begin 30 days after the Secretary has received from the
manufacturer or sponsor of the investigation a submission containing
such information about the drug and the clinical investigation,
including–
“(A) information on design of the investigation and
adequate reports of basic information, certified by the
applicant to be accurate reports, necessary to assess the safety
of the drug for use in clinical investigation; and
“(B) adequate information on the chemistry and
manufacturing of the drug, controls available for the drug, and
primary data tabulations from animal or human studies.
“(3)(A) At any time, the Secretary may prohibit the sponsor of an
investigation from conducting the investigation (referred to in this
paragraph as a `clinical hold’) if the Secretary makes a determination
described in subparagraph (B). The Secretary shall specify the basis for
the clinical hold, including the specific information available to the
Secretary which served as the basis for such clinical hold, and confirm
such determination in writing.
[[Page 111 STAT. 2316]]
“(B) For purposes of subparagraph (A), a determination described in
this subparagraph with respect to a clinical hold is that–
“(i) the drug involved represents an unreasonable risk to
the safety of the persons who are the subjects of the clinical
investigation, taking into account the qualifications of the
clinical investigators, information about the drug, the design
of the clinical investigation, the condition for which the drug
is to be investigated, and the health status of the subjects
involved; or
“(ii) the clinical hold should be issued for such other
reasons as the Secretary may by regulation establish (including
reasons established by regulation before the date of the
enactment of the Food and Drug Administration Modernization Act
of 1997).
“(C) Any written request to the Secretary from the sponsor of an
investigation that a clinical hold be removed shall receive a decision,
in writing and specifying the reasons therefor, within 30 days after
receipt of such request. Any such request shall include sufficient
information to support the removal of such clinical hold.
“(4) Regulations under paragraph (1) shall provide that such
exemption shall be conditioned upon the manufacturer, or the sponsor of
the investigation, requiring that experts using such drugs for
investigational purposes certify to such manufacturer or sponsor that
they will inform any human beings to whom such drugs, or any controls
used in connection therewith, are being administered, or their
representatives, that such drugs are being used for investigational
purposes and will obtain the consent of such human beings or their
representatives, except where it is not feasible or it is contrary to
the best interests of such human beings. Nothing in this subsection
shall be construed to require any clinical investigator to submit
directly to the Secretary reports on the investigational use of
drugs.”.
<> SEC. 118. DATA REQUIREMENTS FOR DRUGS AND
BIOLOGICS.
Within 12 months after the date of enactment of this Act, the
Secretary of Health and Human Services, acting through the Commissioner
of Food and Drugs, shall issue guidance that describes when abbreviated
study reports may be submitted, in lieu of full reports, with a new drug
application under section 505(b) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(b)) and with a biologics license application under
section 351 of the Public Health Service Act (42 U.S.C. 262) for certain
types of studies. Such guidance shall describe the kinds of studies for
which abbreviated reports are appropriate and the appropriate
abbreviated report formats.
SEC. 119. CONTENT AND REVIEW OF APPLICATIONS.
(a) Section 505(b).–Section 505(b) (21 U.S.C. 355(b)) is amended by
adding at the end the following:
“(4)(A) The Secretary shall issue guidance for the individuals who
review applications submitted under paragraph (1) or under section 351
of the Public Health Service Act, which shall relate to promptness in
conducting the review, technical excellence, lack of bias and conflict
of interest, and knowledge of regulatory and scientific standards, and
which shall apply equally to all individuals who review such
applications.
[[Page 111 STAT. 2317]]
“(B) The Secretary shall meet with a sponsor of an investigation or
an applicant for approval for a drug under this subsection or section
351 of the Public Health Service Act if the sponsor or applicant makes a
reasonable written request for a meeting for the purpose of reaching
agreement on the design and size of clinical trials intended to form the
primary basis of an effectiveness claimA Claim A claim is “factually unsustainable” where it could be said with confidence before trial that the factual basis for the claim is entirely without substance, which can be the case if it were clear beyond question that the facts pleaded are contradicted by all the documents or other material on which it is based.. The sponsor or applicant shall
provide information necessary for discussion and agreement on the design
and size of the clinical trials. Minutes of any such meeting shall be
prepared by the Secretary and made available to the sponsor or applicant
upon request.
“(C) Any agreement regarding the parameters of the design and size
of clinical trials of a new drug under this paragraph that is reached
between the Secretary and a sponsor or applicant shall be reduced to
writing and made part of the administrative record by the Secretary.
Such agreement shall not be changed after the testing begins, except–
“(i) with the written agreement of the sponsor or
applicant; or
“(ii) pursuant to a decision, made in accordance with
subparagraph (D) by the director of the reviewing division, that
a substantial scientific issue essential to determining the
safety or effectiveness of the drug has been identified after
the testing has begun.
“(D) A decision under subparagraph (C)(ii) by the director shall be
in writing and the Secretary shall provide to the sponsor or applicant
an opportunity for a meeting at which the director and the sponsor or
applicant will be present and at which the director will document the
scientific issue involved.
“(E) The written decisions of the reviewing division shall be
binding upon, and may not directly or indirectly be changed by, the
field or compliance division personnel unless such field or compliance
division personnel demonstrate to the reviewing division why such
decision should be modified.
“(F) No action by the reviewing division may be delayed because of
the unavailability of information from or action by field personnel
unless the reviewing division determines that a delay is necessary to
assure the marketing of a safe and effective drug.
“(G) For purposes of this paragraph, the reviewing division is the
division responsible for the review of an application for approval of a
drug under this subsection or section 351 of the Public Health Service
Act (including all scientific and medical matters, chemistry,
manufacturing, and controls).”.
(b) Section 505(j).–
(1) Amendment.–Section 505(j) (21 U.S.C 355(j)) is
amended–
(A) by redesignating paragraphs (3) through (8) as
paragraphs (4) through (9), respectively; and
(B) by adding after paragraph (2) the following:
“(3)(A) The Secretary shall issue guidance for the individuals who
review applications submitted under paragraph (1), which shall relate to
promptness in conducting the review, technical excellence, lack of bias
and conflict of interest, and knowledge of regulatory and scientific
standards, and which shall apply equally to all individuals who review
such applications.
“(B) The Secretary shall meet with a sponsor of an investigation or
an applicant for approval for a drug under this subsection if the
sponsor or applicant makes a reasonable written request for
[[Page 111 STAT. 2318]]
a meeting for the purpose of reaching agreement on the design and size
of bioavailability and bioequivalence studies needed for approval of
such application. The sponsor or applicant shall provide information
necessary for discussion and agreement on the design and size of such
studies. Minutes of any such meeting shall be prepared by the Secretary
and made available to the sponsor or applicant.
“(C) Any agreement regarding the parameters of design and size of
bioavailability and bioequivalence studies of a drug under this
paragraph that is reached between the Secretary and a sponsor or
applicant shall be reduced to writing and made part of the
administrative record by the Secretary. Such agreement shall not be
changed after the testing begins, except–
“(i) with the written agreement of the sponsor or
applicant; or
“(ii) pursuant to a decision, made in accordance with
subparagraph (D) by the director of the reviewing division, that
a substantial scientific issue essential to determining the
safety or effectiveness of the drug has been identified after
the testing has begun.
“(D) A decision under subparagraph (C)(ii) by the director shall be
in writing and the Secretary shall provide to the sponsor or applicant
an opportunity for a meeting at which the director and the sponsor or
applicant will be present and at which the director will document the
scientific issue involved.
“(E) The written decisions of the reviewing division shall be
binding upon, and may not directly or indirectly be changed by, the
field or compliance office personnel unless such field or compliance
office personnel demonstrate to the reviewing division why such decision
should be modified.
“(F) No action by the reviewing division may be delayed because of
the unavailability of information from or action by field personnel
unless the reviewing division determines that a delay is necessary to
assure the marketing of a safe and effective drug.
“(G) For purposes of this paragraph, the reviewing division is the
division responsible for the review of an application for approval of a
drug under this subsection (including scientific matters, chemistry,
manufacturing, and controls).”.
(2) Conforming amendments.–Section 505(j) (21 U.S.C.
355(j)), as amended by paragraph (1), is further amended–
(A) in paragraph (2)(A)(i), by striking “(6)” and
inserting “(7)”;
(B) in paragraph (4) (as redesignated in paragraph
(1)), by striking “(4)” and inserting “(5)”;
(C) in paragraph (4)(I) (as redesignated in
paragraph (1)), by striking “(5)” and inserting
“(6)”; and
(D) in paragraph (7)(C) (as redesignated in
paragraph (1)), by striking “(5)” each place it occurs
and inserting “(6)”.
SEC. 120. SCIENTIFIC ADVISORY PANELS.
Section 505 (21 U.S.C. 355) is amended by adding at the end the
following:
“(n)(1) For the purpose of providing expert scientific advice and
recommendations to the Secretary regarding a clinical investigation of a
drug or the approval for marketing of a drug under section 505 or
section 351 of the Public Health Service Act, the
[[Page 111 STAT. 2319]]
Secretary shall establish panels of experts or use panels of experts
established before the date of enactment of the Food and Drug
Administration Modernization Act of 1997, or both.
“(2) The Secretary may delegate the appointment and oversight
authority granted under section 904 to a director of a center or
successor entity within the Food and Drug Administration.
“(3) The Secretary shall make appointments to each panel
established under paragraph (1) so that each panel shall consist of–
“(A) members who are qualified by training and experience
to evaluate the safety and effectiveness of the drugs to be
referred to the panel and who, to the extent feasible, possess
skill and experience in the development, manufacture, or
utilization of such drugs;
“(B) members with diverse expertise in such fields as
clinical and administrative medicine, pharmacy, pharmacology,
pharmacoeconomics, biological and physical sciences, and other
related professions;
“(C) a representative of consumer interests, and a
representative of interests of the drug manufacturing industry
not directly affected by the matter to be brought before the
panel; and
“(D) two or more members who are specialists or have other
expertise in the particular disease or condition for which the
drug under review is proposed to be indicated.
Scientific, trade, and consumer organizations shall be afforded an
opportunity to nominate individuals for appointment to the panels. No
individual who is in the regular full-time employ of the United States
and engaged in the administration of this Act may be a voting member of
any panel. The Secretary shall designate one of the members of each
panel to serve as chairman thereof.
“(4) Each member of a panel shall publicly disclose all conflicts
of interest that member may have with the work to be undertaken by the
panel. No member of a panel may vote on any matter where the member or
the immediate family of such member could gain financially from the
advice given to the Secretary. The Secretary may grant a waiver of any
conflict of interest requirement upon public disclosure of such conflict
of interest if such waiver is necessary to afford the panel essential
expertise, except that the Secretary may not grant a waiver for a member
of a panel when the member’s own scientific work is involved.
“(5) The Secretary shall, as appropriate, provide education and
training to each new panel member before such member participates in a
panel’s activities, including education regarding requirements under
this Act and related regulations of the Secretary, and the
administrative processes and procedures related to panel meetings.
“(6) Panel members (other than officers or employees of the United
States), while attending meetings or conferences of a panel or otherwise
engaged in its business, shall be entitled to receive compensation for
each day so engaged, including traveltime, at rates to be fixed by the
Secretary, but not to exceed the daily equivalent of the rate in effect
for positions classified above grade GS-15 of the General Schedule.
While serving away from their homes or regular places of business, panel
members may be allowed travel expenses (including per diem in lieu of
subsistence) as authorized by section 5703 of title 5, United States
Code, for persons in the Government service employed intermittently.
[[Page 111 STAT. 2320]]
“(7) The Secretary shall ensure that scientific advisory panels
meet regularly and at appropriate intervals so that any matter to be
reviewed by such a panel can be presented to the panel not more than 60
days after the matter is ready for such review. Meetings of the panel
may be held using electronic communication to convene the meetings.
“(8) Within 90 days after a scientific advisory panel makes
recommendations on any matter under its review, the Food and Drug
Administration official responsible for the matter shall review the
conclusions and recommendations of the panel, and notify the affected
persons of the final decision on the matter, or of the reasons that no
such decision has been reached. Each such final decision shall be
documented including the rationale for the decision.”.
SEC. 121. POSITRON EMISSION TOMOGRAPHY.
(a) Regulation of Compounded Positron Emission Tomography Drugs.–
Section 201 (21 U.S.C. 321) is amended by adding at the end the
following:
“(ii) The term `compounded positron emission tomography drug’–
“(1) means a drug that–
“(A) exhibits spontaneous disintegration of
unstable nuclei by the emission of positrons and is used
for the purpose of providing dual photon positron
emission tomographic diagnostic images; and
“(B) has been compounded by or on the order of a
practitioner who is licensed by a State to compound or
order compounding for a drug described in subparagraph
(A), and is compounded in accordance with that State’s
law, for a patient or for research, teaching, or quality
control; and
“(2) includes any nonradioactive reagent, reagent kit,
ingredient, nuclide generator, accelerator, target material,
electronic synthesizer, or other apparatus or computer program
to be used in the preparation of such a drug.”.
(b) Adulteration.–
(1) In general.–Section 501(a) (21 U.S.C. 351(a)) is
amended by striking “; or (3)” and inserting the following:
“; or (C) if it is a compounded positron emission tomography
drug and the methods used in, or the facilities and controls
used for, its compounding, processing, packing, or holding do
not conform to or are not operated or administered in conformity
with the positron emission tomography compounding standards and
the official monographs of the United States Pharmacopoeia to
assure that such drug meets the requirements of this Act as to
safety and has the identity and strength, and meets the quality
and purity characteristics, that it purports or is represented
to possess; or (3)”.
<> (2) Sunset.–Section
501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 351(a)(2)(C)) shall not apply 4 years after the date of
enactment of this Act or 2 years after the date on which the
Secretary of Health and Human Services establishes the
requirements described in subsection (c)(1)(B), whichever is
later.
[[Page 111 STAT. 2321]]
<> (c) Requirements for Review of Approval
Procedures and Current Good Manufacturing Practices for Positron
Emission Tomography.–
(1) Procedures and requirements.–
(A) In general.–In order to take account of the
special characteristics of positron emission tomography
drugs and the special techniques and processes required
to produce these drugs, not later than 2 years after the
date of enactment of this Act, the Secretary of Health
and Human Services shall establish–
(i) appropriate procedures for the approval of
positron emission tomography drugs pursuant to
section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355); and
(ii) appropriate current good manufacturing
practice requirements for such drugs.
(B) Considerations and consultation.–In
establishing the procedures and requirements required by
subparagraph (A), the Secretary of Health and Human
Services shall take due account of any relevant
differences between not-for-profit institutions that
compound the drugs for their patients and commercial
manufacturers of the drugs. Prior to establishing the
procedures and requirements, the Secretary of Health and
Human Services shall consult with patient advocacy
groups, professional associations, manufacturers, and
physicians and scientists licensed to make or use
positron emission tomography drugs.
(2) Submission of new drug applications and abbreviated new
drug applications.–
(A) In general.–Except as provided in subparagraph
(B), the Secretary of Health and Human Services shall
not require the submission of new drug applications or
abbreviated new drug applications under subsection (b)
or (j) of section 505 (21 U.S.C. 355), for compounded
positron emission tomography drugs that are not
adulterated drugs described in section 501(a)(2)(C) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351(a)(2)(C)) (as amended by subsection (b)), for a
period of 4 years after the date of enactment of this
Act, or for 2 years after the date on which the
Secretary establishes procedures and requirements under
paragraph (1), whichever is longer.
(B) Exception.–Nothing in this Act shall prohibit
the voluntary submission of such applications or the
review of such applications by the Secretary of Health
and Human Services. Nothing in this Act shall constitute
an exemption for a positron emission tomography drug
from the requirements of regulations issued under
section 505(i) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(i)).
<> (d) Revocation of Certain
Inconsistent Documents.–Within 30 days after the date of enactment of
this Act, the Secretary of Health and Human Services shall publish in
the Federal Register a notice terminating the application of the
following notices and rule:
(1) A notice entitled “Regulation of Positron Emission
Tomography Radiopharmaceutical Drug Products; Guidance; Public
Workshop”, published in the Federal Register on February 27,
1995, 60 Fed. Reg. 10594.
[[Page 111 STAT. 2322]]
(2) A notice entitled “Draft Guideline on the Manufacture
of Positron Emission Tomography Radiopharmaceutical Drug
Products; Availability”, published in the Federal Register on
February 27, 1995, 60 Fed. Reg. 10593.
(3) A final rule entitled “Current Good Manufacturing
Practice for Finished Pharmaceuticals; Positron Emission
Tomography”, published in the Federal Register on April 22,
1997, 62 Fed. Reg. 19493 (codified at part 211 of title 21, Code
of Federal Regulations).
<> (e) Definition.–As used in this
section, the term “compounded positron emission tomography drug” has
the meaning given the term in section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321).
<> SEC. 122. REQUIREMENTS FOR
RADIOPHARMACEUTICALS.
(a) Requirements.–
(1) Regulations.–
(A) Proposed regulations.–Not later than 180 days
after the date of enactment of this Act, the Secretary
of Health and Human Services, after consultation with
patient advocacy groups, associations, physicians
licensed to use radiopharmaceuticals, and the regulated
industry, shall issue proposed regulations governing the
approval of radiopharmaceuticals. The regulations shall
provide that the determination of the safety and
effectiveness of such a radiopharmaceutical under
section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) or section 351 of the Public Health
Service Act (42 U.S.C. 262) shall include consideration
of the proposed use of the radiopharmaceutical in the
practice of medicine, the pharmacological and
toxicological activity of the radiopharmaceutical
(including any carrier or ligand component of the
radiopharmaceutical), and the estimated absorbed
radiation dose of the radiopharmaceutical.
(B) Final regulations.–Not later than 18 months
after the date of enactment of this Act, the Secretary
shall promulgate final regulations governing the
approval of the radiopharmaceuticals.
(2) Special rule.–In the case of a radiopharmaceutical, the
indications for which such radiopharmaceutical is approved for
marketing may, in appropriate cases, refer to manifestations of
disease (such as biochemical, physiological, anatomic, or
pathological processes) common to, or present in, one or more
disease states.
(b) Definition.–In this section, the term “radiopharma-ceutical”
means–
(1) an article–
(A) that is intended for use in the diagnosis or
monitoring of a disease or a manifestation of a disease
in humans; and
(B) that exhibits spontaneous disintegration of
unstable nuclei with the emission of nuclear particles
or photons; or
(2) any nonradioactive reagent kit or nuclide generator that
is intended to be used in the preparation of any such article.
[[Page 111 STAT. 2323]]
SEC. 123. MODERNIZATION OF REGULATION.
(a) Licenses.–
(1) In general.–Section 351(a) of the Public Health Service
Act (42 U.S.C. 262(a)) is amended to read as follows:
“(a)(1) No person shall introduce or deliver for introduction into
interstate commerce any biological product unless–
“(A) a biologics license is in effect for the biological
product; and
“(B) each package of the biological product is plainly
marked with–
“(i) the proper name of the biological product
contained in the package;
“(ii) the name, address, and applicable license
number of the manufacturer of the biological product;
and
“(iii) the expiration date of the biological
product.
“(2)(A) The Secretary shall establish, by regulation, requirements
for the approval, suspension, and revocation of biologics licenses.
“(B) The Secretary shall approve a biologics license application–
“(i) on the basis of a demonstration that–
“(I) the biological product that is the subject of
the application is safe, pure, and potent; and
“(II) the facility in which the biological product
is manufactured, processed, packed, or held meets
standards designed to assure that the biological product
continues to be safe, pure, and potent; and
“(ii) if the applicant (or other appropriate person)
consents to the inspection of the facility that is the subject
of the application, in accordance with subsection (c).
“(3) The Secretary shall prescribe requirements under which a
biological product undergoing investigation shall be exempt from the
requirements of paragraph (1).”.
(2) Elimination of existing license requirement.–Section
351(d) of the Public Health Service Act (42 U.S.C. 262(d)) is
amended–
(A) by striking “(d)(1)” and all that follows
through “of this section.”;
(B) in paragraph (2)–
(i) by striking “(2)(A) Upon” and inserting
“(d)(1) Upon” and
(ii) by redesignating subparagraph (B) as
paragraph (2); and
(C) in paragraph (2) (as so redesignated by
subparagraph (B)(ii))–
(i) by striking “subparagraph (A)” and
inserting “paragraph (1)”; and
(ii) by striking “this subparagraph” each
place it appears and inserting “this paragraph”.
(b) Labeling.–Section 351(b) of the Public Health Service Act (42
U.S.C. 262(b)) is amended to read as follows:
“(b) No person shall falsely label or mark any package or container
of any biological product or alter any label or mark on the package or
container of the biological product so as to falsify the label or
mark.”.
[[Page 111 STAT. 2324]]
(c) Inspection.–Section 351(c) of the Public Health Service Act (42
U.S.C. 262(c)) is amended by striking “virus, serum,” and all that
follows and inserting “biological product.”.
(d) Definition; Application.–Section 351 of the Public Health
Service Act (42 U.S.C. 262) is amended by adding at the end the
following:
“(i) In this section, the term `biological product’ means a virus,
therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or
derivative, allergenic product, or analogous product, or arsphenamine or
derivative of arsphenamine (or any other trivalent organic arsenic
compound), applicable to the prevention, treatment, or cure of a disease
or condition of human beings.”.
(e) Conforming Amendment.–Section 503(g)(4) (21 U.S.C. 353(g)(4))
is amended–
(1) in subparagraph (A)–
(A) by striking “section 351(a)” and inserting
“section 351(i)”; and
(B) by striking “262(a)” and inserting “262(i)”;
and
(2) in subparagraph (B)(iii), by striking “product or
establishment license under subsection (a) or (d)” and
inserting “biologics license application under subsection
(a)”.
<> (f) Special Rule.–The Secretary of
Health and Human Services shall take measures to minimize differences in
the review and approval of products required to have approved biologics
license applications under section 351 of the Public Health Service Act
(42 U.S.C. 262) and products required to have approved new drug
applications under section 505(b)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(b)(1)).
(g) Application of Federal Food, Drug, and Cosmetic Act.–Section
351 of the Public Health Service Act (42 U.S.C. 262), as amended by
subsection (d), is further amended by adding at the end the following:
“(j) The Federal Food, Drug, and Cosmetic Act applies to a
biological product subject to regulation under this section, except that
a product for which a license has been approved under subsection (a)
shall not be required to have an approved application under section 505
of such Act.”.
(h) Examinations and Procedures.–Paragraph (3) of section 353(d) of
the Public Health Service Act (42 U.S.C. 263a(d)) is amended to read as
follows:
“(3) Examinations and procedures.–The examinations and
procedures identified in paragraph (2) are laboratory
examinations and procedures that have been approved by the Food
and Drug Administration for home use or that, as determined by
the Secretary, are simple laboratory examinations and procedures
that have an insignificant risk of an erroneous result,
including those that–
“(A) employ methodologies that are so simple and
accurate as to render the likelihood of erroneous
results by the user negligible, or
“(B) the Secretary has determined pose no
unreasonable risk of harm to the patient if performed
incorrectly.”.
SEC. 124. PILOT AND SMALL SCALE MANUFACTURE.
(a) Human Drugs.–Section 505(c) (21 U.S.C. 355(c)) is amended by
adding at the end the following:
[[Page 111 STAT. 2325]]
“(4) A drug manufactured in a pilot or other small facility may be
used to demonstrate the safety and effectiveness of the drug and to
obtain approval for the drug prior to manufacture of the drug in a
larger facility, unless the Secretary makes a determination that a full
scale production facility is necessary to ensure the safety or
effectiveness of the drug.”.
(b) Animal Drugs.–Section 512(c) (21 U.S.C. 360b(c)) is amended by
adding at the end the following:
“(4) A drug manufactured in a pilot or other small facility may be
used to demonstrate the safety and effectiveness of the drug and to
obtain approval for the drug prior to manufacture of the drug in a
larger facility, unless the Secretary makes a determination that a full
scale production facility is necessary to ensure the safety or
effectiveness of the drug.”.
SEC. 125. INSULIN AND ANTIBIOTICS.
(a) Certification of Drugs Containing Insulin.–
(1) Amendment.–Section 506 (21 U.S.C. 356), as in effect
before the date of the enactment of this Act, is repealed.
(2) Conforming amendments.–
(A) Section 301(j) (21 U.S.C. 331(j)) is amended by
striking “506, 507,”.
(B) Subsection (k) of section 502 (21 U.S.C. 352) is
repealed.
(C) Sections 301(i)(1), 510(j)(1)(A), and
510(j)(1)(D) (21 U.S.C. 331(i)(1), 360(j)(1)(A),
360(j)(1)(D)) are each amended by striking “, 506,
507,”.
(D) Section 801(d)(1) (21 U.S.C. 381(d)(1)) is
amended by inserting after “503(b)” the following:
“or composed wholly or partly of insulin”.
(E) Section 8126(h)(2) of title 38, United States
Code, is amended by inserting “or” at the end of
subparagraph (B), by striking “; or” at the end of
subparagraph (C) and inserting a period, and by striking
subparagraph (D).
(b) Certification of Antibiotics.–
(1) Amendment.–Section 507 (21 U.S.C. 357) is repealed.
(2) Conforming amendments.–
(A) Section 201(aa) (21 U.S.C. 321(aa)) is amended
by striking out “or 507”, section 201(dd) (21 U.S.C.
321(dd)) is amended by striking “507,”, and section
201(ff)(3)(A) (21 U.S.C. 321(ff)(3)(A)) is amended by
striking “, certified as an antibiotic under section
507,”.
(B) Section 301(e) (21 U.S.C. 331(e)) is amended by
striking “507(d) or (g),”.
(C) Section 306(d)(4)(B)(ii) (21 U.S.C.
335a(d)(4)(B)(ii)) is amended by striking “or 507”.
(D) Section 502 (21 U.S.C. 352) is amended by
striking subsection (l).
(E) Section 520(l) (21 U.S.C. 360j(l)) is amended by
striking paragraph (4) and by striking “or Antibiotic
Drugs” in the subsection heading.
(F) Section 525(a) (21 U.S.C. 360aa(a)) is amended
by inserting “or” at the end of paragraph (1), by
striking paragraph (2), and by redesignating paragraph
(3) as paragraph (2).
[[Page 111 STAT. 2326]]
(G) Section 525(a) (21 U.S.C. 360aa(a)) is amended
by striking “, certification of such drug for such
disease or condition under section 507,”.
(H) Section 526(a)(1) (21 U.S.C. 360bb) is amended
by striking “the submission of an application for
certification of the drug under section 507,”, by
inserting “or” at the end of subparagraph (A), by
striking subparagraph (B), and by redesignating
subparagraph (C) as subparagraph (B).
(I) Section 526(b) (21 U.S.C. 360bb(b)) is amended–
(i) in paragraph (1), by striking “, a
certificate was issued for the drug under section
507,”; and
(ii) in paragraph (2) by striking “, a
certificate has not been issued for the drug under
section 507,” and by striking “, approval of an
application for certification under section
507,”.
(J) Section 527(a) (21 U.S.C. 360cc(a)) is amended
by inserting “or” at the end of paragraph (1), by
striking paragraph (2), by redesignating paragraph (3)
as paragraph (2), and by striking “, issue another
certification under section 507,”.
(K) Section 527(b) (21 U.S.C. 360cc(b)) is amended
by striking “, if a certification is issued under
section 507 for such a drug,”, “, of the issuance of
the certification under section 507,”, “, issue
another certification under section 507,”, “, of such
certification,”, “, of the certification,”, and “,
issuance of other certifications,”.
(L) Section 704(a)(1) (21 U.S.C. 374(a)(1)) is
amended by striking “, section 507 (d) or (g),”.
(M) Section 735(1) (21 U.S.C. 379g(1)(C)) is amended
by inserting “or” at the end of subparagraph (B), by
striking subparagraph (C), and by redesignating
subparagraph (D) as subparagraph (C).
(N) Subparagraphs (A)(ii) and (B) of sections
5(b)(1) of the Orphan Drug Act (21 U.S.C.
360ee(b)(1)(A), 360ee(b)(1)(B)) are each amended by
striking “or 507”.
(O) Section 45C(b)(2)(A)(ii)(II) of the Internal
Revenue Code of 1986 <> is amended
by striking “or 507”.
(P) Section 156(f)(4)(B) of title 35, United States
Code, is amended by striking “507,” each place it
occurs.
(c) Exportation.–Section 802 (21 U.S.C. 382) is amended by adding
at the end the following:
“(i) Insulin and antibiotic drugs may be exported without regard to
the requirements in this section if the insulin and antibiotic drugs
meet the requirements of section 801(e)(1).”.
<> (d) Transition.–
(1) In general.–An application that was approved by the
Secretary of Health and Human Services before the date of the
enactment of this Act for the marketing of an antibiotic drug
under section 507 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 357), as in effect on the day before the date of the
enactment of this Act, shall, on and after such date of
enactment, be considered to be an application that was submitted
and filed under section 505(b) of such Act (21 U.S.C. 355(b))
and approved for safety and effectiveness under section
[[Page 111 STAT. 2327]]
505(c) of such Act (21 U.S.C. 355(c)), except that if such
application for marketing was in the form of an abbreviated
application, the application shall be considered to have been
filed and approved under section 505(j) of such Act (21 U.S.C.
355(j)).
(2) Exception.–The following subsections of section 505 (21
U.S.C. 355) shall not apply to any application for marketing in
which the drug that is the subject of the application contains
an antibiotic drug and the antibiotic drug was the subject of
any application for marketing received by the Secretary of
Health and Human Services under section 507 of such Act (21
U.S.C. 357) before the date of the enactment of this Act:
(A)(i) Subsections (c)(2), (d)(6), (e)(4),
(j)(2)(A)(vii), (j)(2)(A)(viii), (j)(2)(B), (j)(4)(B),
and (j)(4)(D); and
(ii) The third and fourth sentences of subsection
(b)(1) (regarding the filing and publication of patent
information); and
(B) Subsections (b)(2)(A), (b)(2)(B), (b)(3), and
(c)(3) if the investigations relied upon by the
applicant for approval of the application were not
conducted by or for the applicant and for which the
applicant has not obtained a right of reference or use
from the person by or for whom the investigations were
conducted.
(3) Publication.–For purposes of this section, the
Secretary is authorized to make available to the public the
established name of each antibiotic drug that was the subject of
any application for marketing received by the Secretary for
Health and Human Services under section 507 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 357) before the date of
enactment of this Act.
(e) Definition.–Section 201 (21 U.S.C. 321), as amended by section
121(a)(1), is further amended by adding at the end the following:
“(jj) The term `antibiotic drug’ means any drug (except drugs for
use in animals other than humans) composed wholly or partly of any kind
of penicillin, streptomycin, chlortetracycline, chloramphenicol,
bacitracin, or any other drug intended for human use containing any
quantity of any chemical substance which is produced by a micro-organism
and which has the capacity to inhibit or destroy micro-organisms in
dilute solution (including a chemically synthesized equivalent of any
such substance) or any derivative thereof.”.
SEC. 126. ELIMINATION OF CERTAIN LABELING REQUIREMENTS.
(a) Prescription Drugs.–Section 503(b)(4) (21 U.S.C. 353(b)(4)) is
amended to read as follows:
“(4)(A) A drug that is subject to paragraph (1) shall be deemed to
be misbranded if at any time prior to dispensing the label of the drug
fails to bear, at a minimum, the symbol `Rx only’.
“(B) A drug to which paragraph (1) does not apply shall be deemed
to be misbranded if at any time prior to dispensing the label of the
drug bears the symbol described in subparagraph (A).”.
(b) Misbranded Drug.–Section 502(d) (21 U.S.C. 352(d)) is repealed.
(c) Conforming Amendments.–
(1) Section 503(b)(1) (21 U.S.C. 353(b)(1)) is amended–
(A) by striking subparagraph (A); and
[[Page 111 STAT. 2328]]
(B) by redesignating subparagraphs (B) and (C) as
subparagraphs (A) and (B), respectively.
(2) Section 503(b)(3) (21 U.S.C. 353(b)(3)) is amended by
striking “section 502(d) and”.
(3) Section 102(9)(A) of the Controlled Substances Act (21
U.S.C. 802(9)(A)) is amended–
(A) in clause (i), by striking “(i)”; and
(B) by striking “(ii)” and all that follows.
SEC. 127. APPLICATION OF FEDERAL LAW TO PRACTICE OF PHARMACY
COMPOUNDING.
(a) Amendment.–Chapter V is amended by inserting after section 503
(21 U.S.C. 353) the following:
<> “SEC. 503A. PHARMACY COMPOUNDING.
“(a) In General.–Sections 501(a)(2)(B), 502(f)(1), and 505 shall
not apply to a drug product if the drug product is compounded for an
identified individual patient based on the unsolicited receipt of a
valid prescription order or a notation, approved by the prescribing
practitioner, on the prescription order that a compounded product is
necessary for the identified patient, if the drug product meets the
requirements of this section, and if the compounding–
“(1) is by–
“(A) a licensed pharmacist in a State licensed
pharmacy or a Federal facility, or
“(B) a licensed physicianPhysician A person who is trained and licensed to practice medicine. Physicians help prevent, diagnose, treat, and manage injuries, diseases, and other conditions. There are many different types of physicians, including internists, pediatricians, psychiatrists, and surgeons.,
on the prescription order for such individual patient made by a
licensed physician or other licensed practitioner authorized by
State law to prescribe drugs; or
“(2)(A) is by a licensed pharmacist or licensed physician
in limited quantities before the receipt of a valid prescription
order for such individual patient; and
“(B) is based on a history of the licensed pharmacist or
licensed physician receiving valid prescription orders for the
compounding of the drug product, which orders have been
generated solely within an established relationship between–
“(i) the licensed pharmacist or licensed physician;
and
“(ii)(I) such individual patient for whom the
prescription order will be provided; or
“(II) the physician or other licensed practitioner
who will write such prescription order.
“(b) Compounded Drug.–
“(1) Licensed pharmacist and licensed physician.–A drug
product may be compounded under subsection (a) if the licensed
pharmacist or licensed physician–
“(A) compounds the drug product using bulk drug
substances, as defined in regulations of the Secretary
published at section 207.3(a)(4) of title 21 of the Code
of Federal Regulations–
“(i) that–
“(I) comply with the standards of
an applicable United States
Pharmacopoeia or National Formulary
monograph, if a monograph exists, and
the United States Pharmacopoeia chapter
on pharmacy compounding;
“(II) if such a monograph does not
exist, are drug substances that are
components of drugs approved by the
Secretary; or
[[Page 111 STAT. 2329]]
“(III) if such a monograph does not
exist and the drug substance is not a
component of a drug approved by the
Secretary, that appear on a list
developed by the Secretary through
regulations issued by the Secretary
under subsection (d);
“(ii) that are manufactured by an
establishment that is registered under section 510
(including a foreign establishment that is
registered under section 510(i)); and
“(iii) that are accompanied by valid
certificates of analysis for each bulk drug
substance;
“(B) compounds the drug product using ingredients
(other than bulk drug substances) that comply with the
standards of an applicable United States Pharmacopoeia
or National Formulary monograph, if a monograph exists,
and the United States Pharmacopoeia chapter on pharmacy
compounding;
“(C) does not compound a drug product that appears
on a list published by the Secretary in the Federal
Register of drug products that have been withdrawn or
removed from the market because such drug products or
components of such drug products have been found to be
unsafe or not effective; and
“(D) does not compound regularly or in inordinate
amounts (as defined by the Secretary) any drug products
that are essentially copies of a commercially available
drug product.
“(2) Definition.–For purposes of paragraph (1)(D), the
term `essentially a copy of a commercially available drug
product’ does not include a drug product in which there is a
change, made for an identified individual patient, which
produces for that patient a significant difference, as
determined by the prescribing practitioner, between the
compounded drug and the comparable commercially available drug
product.
“(3) Drug product.–A drug product may be compounded under
subsection (a) only if–
“(A) such drug product is not a drug product
identified by the Secretary by regulation as a drug
product that presents demonstrable difficulties for
compounding that reasonably demonstrate an adverse
effect on the safety or effectiveness of that drug
product; and
“(B) such drug product is compounded in a State–
“(i) that has entered into a memorandum of
understanding with the Secretary which addresses
the distribution of inordinate amounts of
compounded drug products interstate and provides
for appropriate investigation by a State agency of
complaints relating to compounded drug products
distributed outside such State; or
“(ii) that has not entered into the
memorandum of understanding described in clause
(i) and the licensed pharmacist, licensed
pharmacy, or licensed physician distributes (or
causes to be distributed) compounded drug products
out of the State in which they are compounded in
quantities that do not exceed 5 percent of the
total prescription orders dispensed or distributed
by such pharmacy or physician.
[[Page 111 STAT. 2330]]
The Secretary shall, in consultation with the National
Association of Boards of Pharmacy, develop a standard memorandum
of understanding for use by the States in complying with
subparagraph (B)(i).
“(c) Advertising and Promotion.–A drug may be compounded under
subsection (a) only if the pharmacy, licensed pharmacist, or licensed
physician does not advertise or promote the compounding of any
particular drug, class of drug, or type of drug. The pharmacy, licensed
pharmacist, or licensed physician may advertise and promote the
compounding service provided by the licensed pharmacist or licensed
physician.
“(d) Regulations.–
“(1) In general.–The Secretary shall issue regulations to
implement this section. Before issuing regulations to implement
subsections (b)(1)(A)(i)(III), (b)(1)(C), or (b)(3)(A), the
Secretary shall convene and consult an advisory committee on
compounding unless the Secretary determines that the issuance of
such regulations before consultation is necessary to protect the
public health. The advisory committee shall include
representatives from the National Association of Boards of
Pharmacy, the United States Pharmacopoeia, pharmacy, physician,
and consumer organizations, and other experts selected by the
Secretary.
“(2) Limiting compounding.–The Secretary, in consultation
with the United States Pharmacopoeia Convention, Incorporated,
shall promulgate regulations identifying drug substances that
may be used in compounding under subsection (b)(1)(A)(i)(III)
for which a monograph does not exist or which are not components
of drug products approved by the Secretary. The Secretary shall
include in the regulation the criteria for such substances,
which shall include historical use, reports in peer reviewed
medical literature, or other criteria the Secretary may
identify.
“(e) Application.–This section shall not apply to–
“(1) compounded positron emission tomography drugs as
defined in section 201(ii); or
“(2) radiopharmaceuticals.
“(f) Definition.–As used in this section, the term `compounding’
does not include mixing, reconstituting, or other such acts that are
performed in accordance with directions contained in approved labeling
provided by the product’s manufacturer and other manufacturer directions
consistent with that labeling.”.
<> (b) Effective Date.–Section 503A of
the Federal Food, Drug, and Cosmetic Act, added by subsection (a), shall
take effect upon the expiration of the 1-year period beginning on the
date of the enactment of this Act.
SEC. 128. REAUTHORIZATION OF CLINICAL PHARMACOLOGY PROGRAM.
Section 2 of Public Law 102-222 (105 Stat. 1677) is amended–
(1) in subsection (a), by striking “a grant” and all that
follows through “Such grant” and inserting the following:
“grants for a pilot program for the training of individuals in
clinical pharmacology at appropriate medical schools. Such
grants”; and
[[Page 111 STAT. 2331]]
(2) in subsection (b), by striking “to carry out this
section” and inserting “, and for fiscal years 1998 through
2002 $3,000,000 for each fiscal year, to carry out this
section”.
<> SEC. 129. REGULATIONS FOR SUNSCREEN PRODUCTS.
Not later than 18 months after the date of enactment of this Act,
the Secretary of Health and Human Services shall issue regulations for
over-the-counter sunscreen products for the prevention or treatment of
sunburn.
SEC. 130. REPORTS OF POSTMARKETING APPROVAL STUDIES.
(a) In General.–Chapter V, as amended by section 116, is further
amended by inserting after section 506A the following:
<> “SEC. 506B. REPORTS OF POSTMARKETING STUDIES.
“(a) Submission.–
“(1) In general.–A sponsor of a drug that has entered into
an agreement with the Secretary to conduct a postmarketing study
of a drug shall submit to the Secretary, within 1 year after the
approval of such drug and annually thereafter until the study is
completed or terminated, a report of the progress of the study
or the reasons for the failure of the sponsor to conduct the
study. The report shall be submitted in such form as is
prescribed by the Secretary in regulations issued by the
Secretary.
“(2) Agreements prior to effective date.–Any agreement
entered into between the Secretary and a sponsor of a drug,
prior to the date of enactment of the Food and Drug
Administration Modernization Act of 1997, to conduct a
postmarketing study of a drug shall be subject to the
requirements of paragraph (1). An initial report for such an
agreement shall be submitted within 6 months after the date of
the issuance of the regulations under paragraph (1).
“(b) Consideration of Information as Public Information.–Any
information pertaining to a report described in subsection (a) shall be
considered to be public information to the extent that the information
is necessary–
“(1) to identify the sponsor; and
“(2) to establish the status of a study described in
subsection (a) and the reasons, if any, for any failure to carry
out the study.
<> “(c) Status of Studies
and Reports.–The Secretary shall annually develop and publish in the
Federal Register a report that provides information on the status of the
postmarketing studies–
“(1) that sponsors have entered into agreements to conduct;
and
“(2) for which reports have been submitted under subsection
(a)(1).”.
<> (b) Report to Congressional
Committees.–Not later than October 1, 2001, the Secretary shall prepare
and submit to the Committee on Labor and Human Resources of the Senate
and the Committee on Commerce of the House of Representatives a report
containing–
(1) a summary of the reports submitted under section 506B of
the Federal Food, Drug, and Cosmetic Act;
(2) an evaluation of–
[[Page 111 STAT. 2332]]
(A) the performance of the sponsors referred to in
such section in fulfilling the agreements with respect
to the conduct of postmarketing studies described in
such section of such Act; and
(B) the timeliness of the Secretary’s review of the
postmarketing studies; and
(3) any legislative recommendations respecting the
postmarketing studies.
SEC. 131. NOTIFICATION OF DISCONTINUANCE OF A LIFE SAVING PRODUCT.
(a) In General.–Chapter V, as amended by section 130, is further
amended by inserting after section 506B the following:
<> “SEC. 506C. DISCONTINUANCE OF A LIFE SAVING
PRODUCT.
“(a) In General.–A manufacturer that is the sole manufacturer of a
drug–
“(1) that is–
“(A) life-supporting;
“(B) life-sustaining; or
“(C) intended for use in the prevention of a
debilitating disease or condition;
“(2) for which an application has been approved under
section 505(b) or 505(j); and
“(3) that is not a product that was originally derived from
human tissue and was replaced by a recombinant product,
shall notify the Secretary of a discontinuance of the manufacture of the
drug at least 6 months prior to the date of the discontinuance.
“(b) Reduction in Notification Period.–The notification period
required under subsection (a) for a manufacturer may be reduced if the
manufacturer certifies to the Secretary that good cause exists for the
reduction, such as a situation in which–
“(1) a public health problem may result from continuation
of the manufacturing for the 6-month period;
“(2) a biomaterials shortage prevents the continuation of
the manufacturing for the 6-month period;
“(3) a liability problem may exist for the manufacturer if
the manufacturing is continued for the 6-month period;
“(4) continuation of the manufacturing for the 6-month
period may cause substantial economic hardship for the
manufacturer;
“(5) the manufacturer has filed for bankruptcy under
chapter 7 or 11 of title 11, United States Code; or
“(6) the manufacturer can continue the distribution of the
drug involved for 6 months.
“(c) Distribution.–To the maximum extent practicable, the
Secretary shall distribute information on the discontinuation of the
drugs described in subsection (a) to appropriate physician and patient
organizations.”.
TITLE II–IMPROVING REGULATION OF DEVICES
SEC. 201. INVESTIGATIONAL DEVICE EXEMPTIONS.
(a) In General.–Section 520(g) (21 U.S.C. 360j(g)) is amended by
adding at the end the following:
[[Page 111 STAT. 2333]]
“(6)(A) Not later than 1 year after the date of the enactment of
the Food and Drug Administration Modernization Act of 1997, the
Secretary shall by regulation establish, with respect to a device for
which an exemption under this subsection is in effect, procedures and
conditions that, without requiring an additional approval of an
application for an exemption or the approval of a supplement to such an
application, permit–
“(i) developmental changes in the device (including
manufacturing changes) that do not constitute a significant
change in design or in basic principles of operation and that
are made in response to information gathered during the course
of an investigation; and
“(ii) changes or modifications to clinical protocols that
do not affect–
“(I) the validity of data or information resulting
from the completion of an approved protocol, or the
relationship of likely patient risk to benefit relied
upon to approve a protocol;
“(II) the scientific soundness of an
investigational plan submitted under paragraph (3)(A);
or
“(III) the rights, safety, or welfare of the human
subjects involved in the investigation.
“(B) Regulations under subparagraph (A) shall provide that a change
or modification described in such subparagraph may be made if–
“(i) the sponsor of the investigation determines, on the
basis of credible information (as defined by the Secretary) that
the applicable conditions under subparagraph (A) are met; and
“(ii) the sponsor submits to the Secretary, not later than
5 days after making the change or modification, a notice of the
change or modification.
“(7)(A) In the case of a person intending to investigate the safety
or effectiveness of a class III device or any implantable device, the
Secretary shall ensure that the person has an opportunity, prior to
submitting an application to the Secretary or to an institutional review
committee, to submit to the Secretary, for review, an investigational
plan (including a clinical protocol). If the applicant submits a written
request for a meeting with the Secretary regarding such review, the
Secretary shall, not later than 30 days after receiving the request,
meet with the applicant for the purpose of reaching agreement regarding
the investigational plan (including a clinical protocol). The written
request shall include a detailed description of the device, a detailed
description of the proposed conditions of use of the device, a proposed
plan (including a clinical protocol) for determining whether there is a
reasonable assurance of effectiveness, and, if available, information
regarding the expected performance from the device.
“(B) Any agreement regarding the parameters of an investigational
plan (including a clinical protocol) that is reached between the
Secretary and a sponsor or applicant shall be reduced to writing and
made part of the administrative record by the Secretary. Any such
agreement shall not be changed, except–
“(i) with the written agreement of the sponsor or
applicant; or
“(ii) pursuant to a decision, made in accordance with
subparagraph (C) by the director of the office in which the
device involved is reviewed, that a substantial scientific issue
[[Page 111 STAT. 2334]]
essential to determining the safety or effectiveness of the
device involved has been identified.
“(C) A decision under subparagraph (B)(ii) by the director shall be
in writing, and may be made only after the Secretary has provided to the
sponsor or applicant an opportunity for a meeting at which the director
and the sponsor or applicant are present and at which the director
documents the scientific issue involved.”.
(b) Action on Application.–Section 515(d)(1)(B) (21 U.S.C.
360e(d)(1)(B)) is amended by adding at the end the following:
“(iii) The Secretary shall accept and review statistically valid
and reliable data and any other information from investigations
conducted under the authority of regulations required by section 520(g)
to make a determination of whether there is a reasonable assurance of
safety and effectiveness of a device subject to a pending application
under this section if–
“(I) the data or information is derived from investigations
of an earlier version of the device, the device has been
modified during or after the investigations (but prior to
submission of an application under subsection (c)) and such a
modification of the device does not constitute a significant
change in the design or in the basic principles of operation of
the device that would invalidate the data or information; or
“(II) the data or information relates to a device approved
under this section, is available for use under this Act, and is
relevant to the design and intended use of the device for which
the application is pending.”.
SEC. 202. SPECIAL REVIEW FOR CERTAIN DEVICES.
Section 515(d) (21 U.S.C. 360e(d)) is amended–
(1) by redesignating paragraph (3) as paragraph (4); and
(2) by adding at the end the following:
“(5) In order to provide for more effective treatment or diagnosis
of life-threatening or irreversibly debilitating human diseases or
conditions, the Secretary shall provide review priority for devices–
“(A) representing breakthrough technologies,
“(B) for which no approved alternatives exist,
“(C) which offer significant advantages over existing
approved alternatives, or
“(D) the availability of which is in the best interest of
the patients.”.
SEC. 203. EXPANDING HUMANITARIAN USE OF DEVICES.
Section 520(m) (21 U.S.C. 360j(m)) is amended–
(1) in paragraph (2), by adding after and below subparagraph
(C) the following sentences:
“The request shall be in the form of an application submitted to the
Secretary. Not later than 75 days after the date of the receipt of the
application, the Secretary shall issue an order approving or denying the
application.”;
(2) in paragraph (4)–
(A) in subparagraph (B), by inserting after
“(2)(A)” the following: “, unless a physician
determines in an emergency situation that approval from
a local institutional review committee can not be
obtained in time to prevent serious harm or death to a
patient”; and
(B) by adding after and below subparagraph (B) the
following:
“In a case described in subparagraph (B) in which a physician uses a
device without an approval from an institutional review committee, the
physician shall, after the use of the device, notify the chairperson of
the local institutional review committee of such use. Such notification
shall include the identification of the patient involved, the date on
which the device was used, and the reason for the use.”;
(3) by amending paragraph (5) to read as follows:
“(5) The Secretary may require a person granted an exemption under
paragraph (2) to demonstrate continued compliance with the requirements
of this subsection if the Secretary believes such demonstration to be
necessary to protect the public health or if the Secretary has reason to
believe that the criteria for the exemption are no longer met.”; and
(4) by amending paragraph (6) to read as follows:
“(6) The Secretary may suspend or withdraw an exemption from the
effectiveness requirements of sections 514 and 515 for a humanitarian
device only after providing notice and an opportunity for an informal
hearing.”.
SEC. 204. DEVICE STANDARDS.
(a) Alternative Procedure.–Section 514 (21 U.S.C. 360d) is amended
by adding at the end the following:
“Recognition of a Standard
“(c)(1)(A) In addition to
establishing a performance standard under this section, the Secretary
shall, by publication in the Federal Register, recognize all or part of
an appropriate standard established by a nationally or internationally
recognized standard development organization for which a person may
submit a declaration of conformity in order to meet a premarket
submission requirement or other requirement under this Act to which such
standard is applicable.
“(B) If a person elects to use a standard recognized by the
Secretary under subparagraph (A) to meet the requirements described in
such subparagraph, the person shall provide a declaration of conformity
to the Secretary that certifies that the device is in conformity with
such standard. A person may elect to use data, or information, other
than data required by a standard recognized under subparagraph (A) to
meet any requirement regarding devices under this Act.
<> “(2) The Secretary may
withdraw such recognition of a standard through publication of a notice
in the Federal Register if the Secretary determines that the standard is
no longer appropriate for meeting a requirement regarding devices under
this Act.
“(3)(A) Subject to subparagraph (B), the Secretary shall accept a
declaration of conformity that a device is in conformity with a standard
recognized under paragraph (1) unless the Secretary finds–
“(i) that the data or information submitted to support such
declaration does not demonstrate that the device is in
conformity with the standard identified in the declaration of
conformity; or
“(ii) that the standard identified in the declaration of
conformity is not applicable to the particular device under
review.
“(B) The Secretary may request, at any time, the data or
information relied on by the person to make a declaration of conformity
with respect to a standard recognized under paragraph (1).
“(C) A person making a declaration of conformity with respect to a
standard recognized under paragraph (1) shall maintain the data and
information demonstrating conformity of the device to the standard for a
period of two years after the date of the classification or approval of
the device by the Secretary or a period equal to the expected design
life of the device, whichever is longer.”.
(b) Section 301.–Section 301 (21 U.S.C. 331) is amended by adding
at the end the following:
“(x) The falsification of a declaration of conformity submitted
under section 514(c) or the failure or refusal to provide data or
information requested by the Secretary under paragraph (3) of such
section.”.
(c) Section 501.–Section 501(e) (21 U.S.C. 351(e)) is amended–
(1) by striking “(e)” and inserting “(e)(1)”; and
(2) by inserting at the end the following:
“(2) If it is declared to be, purports to be, or is represented as,
a device that is in conformity with any standard recognized under
section 514(c) unless such device is in all respects in conformity with
such standard.”.
(d) Conforming Amendments.–Section 514(a) (21 U.S.C. 360d(a)) is
amended–
(1) in paragraph (1), in the second sentence, by striking
“under this section” and inserting “under subsection (b)”;
(2) in paragraph (2), in the matter preceding subparagraph
(A), by striking “under this section” and inserting “under
subsection (b)”;
(3) in paragraph (3), by striking “under this section” and
inserting “under subsection (b)”; and
(4) in paragraph (4), in the matter preceding subparagraph
(A), by striking “this section” and inserting “this
subsection and subsection (b)”.
SEC. 205. SCOPE OF REVIEW; COLLABORATIVE DETERMINATIONS OF DEVICE
DATA REQUIREMENTS.
(a) Section 513(a).–Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is
amended by adding at the end the following:
“(C) In making a determination of a reasonable assurance of the
effectiveness of a device for which an application under section 515 has
been submitted, the Secretary shall consider whether the extent of data
that otherwise would be required for approval of the application with
respect to effectiveness can be reduced through reliance on postmarket
controls.
“(D)(i) The Secretary, upon the written request of any person
intending to submit an application under section 515, shall meet with
such person to determine the type of valid scientific evidence (within
the meaning of subparagraphs (A) and (B)) that will be necessary to
demonstrate for purposes of approval of an application the effectiveness
of a device for the conditions of use proposed by such person. The
written request shall include a detailed description of the device, a
detailed description of the proposed conditions of use of the device, a
proposed plan for determining whether there is a reasonable assurance of
effectiveness, and, if available, information regarding the expected performance from the device. Within
30 days after such meeting, the Secretary shall specify in writing the
type of valid scientific evidence that will provide a reasonable
assurance that a device is effective under the conditions of use
proposed by such person.
“(ii) Any clinical data, including one or more well-controlled
investigations, specified in writing by the Secretary for demonstrating
a reasonable assurance of device effectiveness shall be specified as
result of a determination by the Secretary that such data are necessary
to establish device effectiveness. The Secretary shall consider, in
consultation with the applicant, the least burdensome appropriate means
of evaluating device effectiveness that would have a reasonable
likelihood of resulting in approval.
“(iii) The determination of the Secretary with respect to the
specification of valid scientific evidence under clauses (i) and (ii)
shall be binding upon the Secretary, unless such determination by the
Secretary could be contrary to the public health.”.
(b) Section 513(i).–Section 513(i)(1) (21 U.S.C. 360c(i)(1)) is
amended by adding at the end the following:
“(C) To facilitate reviews of reports submitted to the Secretary
under section 510(k), the Secretary shall consider the extent to which
reliance on postmarket controls may expedite the classification of
devices under subsection (f)(1) of this section.
“(D) Whenever the Secretary requests information to demonstrate
that devices with differing technological characteristics are
substantially equivalent, the Secretary shall only request information
that is necessary to making substantial equivalence determinations. In
making such request, the Secretary shall consider the least burdensome
means of demonstrating substantial equivalence and request information
accordingly.
“(E)(i) Any determination by the Secretary of the intended use of a
device shall be based upon the proposed labeling submitted in a report
for the device under section 510(k). However, when determining that a
device can be found substantially equivalent to a legally marketed
device, the director of the organizational unit responsible for
regulating devices (in this subparagraph referred to as the `Director’)
may require a statement in labeling that provides appropriate
information regarding a use of the device not identified in the proposed
labeling if, after providing an opportunity for consultation with the
person who submitted such report, the Director determines and states in
writing–
“(I) that there is a reasonable likelihood that the device
will be used for an intended use not identified in the proposed
labeling for the device; and
“(II) that such use could cause harm.
“(ii) Such determination shall–
“(I) be provided to the person who submitted the report
within 10 days from the date of the notification of the
Director’s concerns regarding the proposed labeling;
“(II) specify the limitations on the use of the device not
included in the proposed labeling; and
“(III) find the device substantially equivalent if the
requirements of subparagraph (A) are met and if the labeling for
such device conforms to the limitations specified in subclause
(II).
“(iii) The responsibilities of the Director under this subparagraph
may not be delegated.
“(iv) This subparagraph has no legal effect after the expiration of
the five-year period beginning on the date of the enactment of the Food
and Drug Administration Modernization Act of 1997.”.
(c) Section 515(d).–Section 515(d) (21 U.S.C. 360e(d)) is amended–
(1) in paragraph (1)(A), by adding after and below clause (ii) the following:
“In making the determination whether to approve or deny the
application, the Secretary shall rely on the conditions of use included
in the proposed labeling as the basis for determining whether or not
there is a reasonable assurance of safety and effectiveness, if the
proposed labeling is neither false nor misleading. In determining
whether or not such labeling is false or misleading, the Secretary shall
fairly evaluate all material facts pertinent to the proposed
labeling.”; and
(2) by adding after paragraph (5) (as added by section 202(2)) the following:
“(6)(A)(i) A supplemental application shall be required for any
change to a device subject to an approved application under this
subsection that affects safety or effectiveness, unless such change is a
modification in a manufacturing procedure or method of manufacturing and
the holder of the approved application submits a written notice to the
Secretary that describes in detail the change, summarizes the data or
information supporting the change, and informs the Secretary that the
change has been made under the requirements of section 520(f).
“(ii) The holder of an approved application who submits a notice
under clause (i) with respect to a manufacturing change of a device may
distribute the device 30 days after the date on which the Secretary
receives the notice, unless the Secretary within such 30-day period
notifies the holder that the notice is not adequate and describes such
further information or action that is required for acceptance of such
change. If the Secretary notifies the holder that a supplemental
application is required, the Secretary shall review the supplement
within 135 days after the receipt of the supplement. The time used by
the Secretary to review the notice of the manufacturing change shall be
deducted from the 135-day review period if the notice meets appropriate
content requirements for premarket approval supplements.
“(B)(i) Subject to clause (ii), in reviewing a supplement to an
approved application, for an incremental change to the design of a
device that affects safety or effectiveness, the Secretary shall approve
such supplement if–
“(I) nonclinical data demonstrate that the design
modification creates the intended additional capacity, function,
or performance of the device; and
“(II) clinical data from the approved application and any
supplement to the approved application provide a reasonable
assurance of safety and effectiveness for the changed device.
“(ii) The Secretary may require, when necessary, additional
clinical data to evaluate the design modification of the device to
provide a reasonable assurance of safety and effectiveness.”.
SEC. 206. PREMARKET NOTIFICATION.
(a) Section 510.–Section 510 (21 U.S.C. 360) is amended–
(1) in subsection (k), in the matter preceding paragraph
(1), by adding after “report to the Secretary” the following:
“or person who is accredited under section 523(a)”; and
(2) by adding at the end the following subsections:
“(l) A report under subsection (k) is not required for a device
intended for human use that is exempted from the requirements of this
subsection under subsection (m) or is within a type that has been
classified into class I under section 513. The exception established in
the preceding sentence does not apply to any class I device that is
intended for a use which is of substantial importance in preventing
impairment of human health, or to any class I device that presents a
potential unreasonable risk of illness or injury.
“(m)(1) Not later than 60
days after the date of enactment of the Food and Drug Administration
Modernization Act of 1997, the Secretary shall publish in the Federal
Register a list of each type of class II device that does not require a
report under subsection (k) to provide reasonable assurance of safety
and effectiveness. Each type of class II device identified by the
Secretary as not requiring the report shall be exempt from the
requirement to provide a report under subsection (k) as of the date of
the publication of the list in the Federal Register.
“(2) Beginning on the date that is 1 day after the date of the
publication of a list under this subsection, the Secretary may exempt a
class II device from the requirement to submit a report under subsection
(k), upon the Secretary’s own initiative or a petition of an interested
person, if the Secretary determines that such report is not necessary to
assure the safety and effectiveness of the device. <> The Secretary shall publish in the Federal
Register notice of the intent of the Secretary to exempt the device, or
of the petition, and provide a 30-day period for public comment. Within
120 days <> after the issuance of
the notice in the Federal Register, the Secretary shall publish an order
in the Federal Register that sets forth the final determination of the
Secretary regarding the exemption of the device that was the subject of
the notice. If the Secretary fails to respond to a petition within 180
days of receiving it, the petition shall be deemed to be granted.”.
(b) Section 513(f).–Section 513(f) (21 U.S.C. 360c(f)) is amended
by adding at the end the following:
“(5) The Secretary may not withhold a determination of the initial
classification of a device under paragraph (1) because of a failure to
comply with any provision of this Act unrelated to a substantial
equivalence decision, including a finding that the facility in which the
device is manufactured is not in compliance with good manufacturing
requirements as set forth in regulations of the Secretary under section
520(f) (other than a finding that there is a substantial likelihood that
the failure to comply with such regulations will potentially present a
serious risk to human health).”.
(c) Section 513(i).–Section 513(i)(1) (21 U.S.C. 360c(i)), as
amended by section 205(b), is amended–
(1) in subparagraph (A)(ii)–
(A) in subclause (I), by striking “clinical data”
and inserting “appropriate clinical or scientific
data” and by inserting “or a person accredited under
section 523” after “Secretary”; and
(B) in subclause (II), by striking “efficacy” and
inserting “effectiveness”; and
(2) by adding at the end the following:
“(F) Not later than 270 days after the date of the enactment of the
Food and Drug Administration Modernization Act of 1997, the Secretary
shall issue guidance specifying the general principles that the
Secretary will consider in determining when a specific intended use of a
device is not reasonably included within a general use of such device
for purposes of a determination of substantial equivalence under
subsection (f) or section 520(l).”.
SEC. 207. EVALUATION OF AUTOMATIC CLASS III DESIGNATION.
Section 513(f) (21 U.S.C. 360c(f)), as amended by section 206(b), is
amended–
(1) in paragraph (1)–
(A) in subparagraph (B), by striking “paragraph
(2)” and inserting “paragraph (3)”; and
(B) in the last sentence, by striking “paragraph
(2)” and inserting “paragraph (2) or (3)”;
(2) by redesignating paragraphs (2) and (3) as paragraphs
(3) and (4), respectively; and
(3) by inserting after paragraph (1) the following:
“(2)(A) Any person who submits a report under section 510(k) for a
type of device that has not been previously classified under this Act,
and that is classified into class III under paragraph (1), may request,
within 30 days after receiving written notice of such a classification,
the Secretary to classify the device under the criteria set forth in
subparagraphs (A) through (C) of subsection (a)(1). The person may, in
the request, recommend to the Secretary a classification for the device.
Any such request shall describe the device and provide detailed
information and reasons for the recommended classification.
“(B)(i) Not later than 60 days after the date of the submission of
the request under subparagraph (A), the Secretary shall by written order
classify the device involved. Such classification shall be the initial
classification of the device for purposes of paragraph (1) and any
device classified under this paragraph shall be a predicate device for
determining substantial equivalence under paragraph (1).
“(ii) A device that remains in class III under this subparagraph
shall be deemed to be adulterated within the meaning of section
501(f)(1)(B) until approved under section 515 or exempted from such
approval under section 520(g).
<> “(C) Within 30 days after
the issuance of an order classifying a device under this paragraph, the
Secretary shall publish a notice in the Federal Register announcing such
classification.”.
SEC. 208. CLASSIFICATION PANELS.
Section 513(b) (21 U.S.C. 360c(b)) is amended by adding at the end
the following:
“(5) Classification panels covering each type of device shall be
scheduled to meet at such times as may be appropriate for the Secretary
to meet applicable statutory deadlines.
“(6)(A) Any person whose device is specifically the subject of
review by a classification panel shall have–
“(i) the same access to data and information submitted to a
classification panel (except for data and information that are
not available for public disclosure under section 552 of title
5, United States Code) as the Secretary;
“(ii) the opportunity to submit, for review by a
classification panel, information that is based on the data or
information provided in the application submitted under section
515 by the person, which information shall be submitted to the
Secretary for prompt transmittal to the classification panel;
and
“(iii) the same opportunity as the Secretary to participate in meetings of the panel.
“(B) Any meetings of a classification panel shall provide adequate
time for initial presentations and for response to any differing views
by persons whose devices are specifically the subject of a
classification panel review, and shall encourage free and open
participation by all interested persons.
“(7) After receiving from a classification panel the conclusions
and recommendations of the panel on a matter that the panel has
reviewed, the Secretary shall review the conclusions and
recommendations, shall make a final decision on the matter in accordance
with section 515(d)(2), and shall notify the affected persons of the
decision in writing and, if the decision differs from the conclusions
and recommendations of the panel, shall include the reasons for the difference.
“(8) A classification panel under this subsection shall not be
subject to the annual chartering and annual report requirements of the
Federal Advisory Committee Act.”.
SEC. 209. CERTAINTY OF REVIEW TIMEFRAMES; COLLABORATIVE REVIEW
PROCESS.
(a) Certainty of Review Timeframes.–Section 510 (21 U.S.C. 360), as
amended by section 206(a)(2), is amended by adding at the end the
following subsection:
“(n) The Secretary shall review the report required in subsection
(k) and make a determination under section 513(f)(1) not later than 90
days after receiving the report.”.
(b) Collaborative Review Process.–Section 515(d) (21 U.S.C.
360e(d)), as amended by section 202(1), is amended by inserting after
paragraph (2) the following:
“(3)(A)(i) The Secretary shall, upon the written request of an
applicant, meet with the applicant, not later than 100 days after the
receipt of an application that has been filed as complete under
subsection (c), to discuss the review status of the application.
“(ii) The Secretary shall, in writing and prior to the meeting,
provide to the applicant a description of any deficiencies in the
application that, at that point, have been identified by the Secretary
based on an interim review of the entire application and identify the
information that is required to correct those deficiencies.
“(iii) The Secretary shall notify the applicant promptly of–
“(I) any additional deficiency identified in the
application, or
“(II) any additional information required to achieve
completion of the review and final action on the application,
that was not described as a deficiency in the written description
provided by the Secretary under clause (ii).
“(B) The Secretary and the applicant may, by mutual consent,
establish a different schedule for a meeting required under this
paragraph.
SEC. 210. ACCREDITATION OF PERSONS FOR REVIEW OF PREMARKET
NOTIFICATION REPORTS.
(a) In General.–Subchapter A of chapter V is amended by adding at
the end the following:
“SEC. 523. ACCREDITED PERSONS.
“(a) In General.–
“(1) Review and classification of devices.–Not later than
1 year after the date of the enactment of the Food and Drug
Administration Modernization Act of 1997, the Secretary shall,
subject to paragraph (3), accredit persons for the purpose of
reviewing reports submitted under section 510(k) and making
recommendations to the Secretary regarding the initial
classification of devices under section 513(f)(1).
“(2) Requirements regarding review.–
“(A) In general.–In making a recommendation to the
Secretary under paragraph (1), an accredited person
shall notify the Secretary in writing of the reasons for
the recommendation.
“(B) Time period for review.–Not later than 30
days after the date on which the Secretary is notified
under subparagraph (A) by an accredited person with
respect to a recommendation of an initial classification
of a device, the Secretary shall make a determination
with respect to the initial classification.
“(C) Special rule.–The Secretary may change the
initial classification under section 513(f)(1) that is
recommended under paragraph (1) by an accredited person,
and in such case shall provide to such person, and the
person who submitted the report under section 510(k) for
the device, a statement explaining in detail the reasons
for the change.
“(3) Certain devices.–
“(A) In general.–An accredited person may not be
used to perform a review of–
“(i) a class III device;
“(ii) a class II device which is intended to
be permanently implantable or life sustaining or
life supporting; or
“(iii) a class II device which requires
clinical data in the report submitted under
section 510(k) for the device, except that the
number of class II devices to which the Secretary
applies this clause for a year, less the number of
such reports to which clauses (i) and (ii) apply,
may not exceed 6 percent of the number that is
equal to the total number of reports submitted to
the Secretary under such section for such year
less the number of such reports to which such
clauses apply for such year.
“(B) Adjustment.–In determining for a year the
ratio described in subparagraph (A)(iii), the Secretary
shall not include in the numerator class III devices
that the Secretary reclassified into class II, and the
Secretary shall include in the denominator class II
devices for which reports under section 510(k) were not
required to be submitted by reason of the operation of
section 510(m).
“(b) Accreditation.–
“(1) Programs.–The Secretary shall provide for such
accreditation through programs administered by the Food and Drug
Administration, other government agencies, or by other qualified
nongovernment organizations.
“(2) Accreditation.–
“(A) In
general.–Not later than 180 days after the date of the
enactment of the Food and Drug Administration
Modernization Act of 1997, the Secretary shall establish
and publish in the Federal Register criteria to accredit
or deny accreditation to persons who request to perform
the duties specified in subsection (a). The Secretary
shall respond to a request for accreditation within 60
days of the receipt of the request. The accreditation of
such person shall specify the particular activities
under subsection (a) for which such person is accredited.
“(B) Withdrawal of accreditation.–The Secretary
may suspend or withdraw accreditation of any person
accredited under this paragraph, after providing notice
and an opportunity for an informal hearing, when such
person is substantially not in compliance with the
requirements of this section or poses a threat to public
health or fails to act in a manner that is consistent
with the purposes of this section.
“(C) Performance auditing.–To ensure that persons
accredited under this section will continue to meet the
standards of accreditation, the Secretary shall–
“(i) make onsite visits on a periodic basis
to each accredited person to audit the performance
of such person; and
“(ii) take such additional measures as the
Secretary determines to be appropriate.
“(D) Annual report.–The Secretary shall include in
the annual report required under section 903(g) the
names of all accredited persons and the particular
activities under subsection (a) for which each such
person is accredited and the name of each accredited
person whose accreditation has been withdrawn during the
year.
“(3) Qualifications.–An accredited person shall, at a
minimum, meet the following requirements:
“(A) Such person may not be an employee of the
Federal Government.
“(B) Such person shall be an independent
organization which is not owned or controlled by a
manufacturer, supplier, or vendor of devices and which
has no organizational, material, or financial
affiliation with such a manufacturer, supplier, or
vendor.
“(C) Such person shall be a legally constituted
entity permitted to conduct the activities for which it
seeks accreditation.
“(D) Such person shall not engage in the design,
manufacture, promotion, or sale of devices.
“(E) The operations of such person shall be in
accordance with generally accepted professional and
ethical business practices and shall agree in writing
that as a minimum it will–
“(i) certify that reported information
accurately reflects data reviewed;
“(ii) limit work to that for which competence
and capacity are available;
“(iii) treat information received, records,
reports, and recommendations as proprietary
information;
“(iv) promptly respond and attempt to resolve
complaints regarding its activities for which it
is accredited; and
“(v) protect against the use, in carrying out
subsection (a) with respect to a device, of any
officer or employee of the person who has a
financial conflict of interest regarding the
device, and annually make available to the public
disclosures of the extent to which the person, and
the officers and employees of the person, have
maintained compliance with requirements under this
clause relating to financial conflicts of
interest.
“(4) Selection of accredited persons.–The Secretary shall
provide each person who chooses to use an accredited person to
receive a section 510(k) report a panel of at least two or more
accredited persons from which the regulated person may select
one for a specific regulatory function.
“(5) Compensation of accredited persons.–Compensation for
an accredited person shall be determined by agreement between
the accredited person and the person who engages the services of
the accredited person, and shall be paid by the person who
engages such services.
“(c) Duration.–The authority provided by this section terminates–
“(1) 5 years after the date on which the Secretary notifies
Congress that at least 2 persons accredited under subsection (b)
are available to review at least 60 percent of the submissions
under section 510(k), or
“(2) 4 years after the date on which the Secretary notifies
Congress that the Secretary has made a determination described
in paragraph (2)(B) of subsection (a) for at least 35 percent of
the devices that are subject to review under paragraph (1) of
such subsection,
whichever occurs first.”.
(b) Recordkeeping.–Section 704 (21 U.S.C. 374) is amended by adding
at the end the following:
“(f)(1) A person accredited under section 523 to review reports
made under section 510(k) and make recommendations of initial
classifications of devices to the Secretary shall maintain records
documenting the training qualifications of the person and the employees
of the person, the procedures used by the person for handling
confidential information, the compensation arrangements made by the
person, and the procedures used by the person to identify and avoid
conflicts of interest. Upon the request of an officer or employee
designated by the Secretary, the person shall permit the officer or
employee, at all reasonable times, to have access to, to copy, and to
verify, the records.
“(2) Within 15 days after the receipt of a written request from the
Secretary to a person accredited under section 523 for copies of records
described in paragraph (1), the person shall produce the copies of the
records at the place designated by the Secretary.”.
(c) Conforming Amendment.–Section 301 (21 U.S.C. 331), as amended
by section 204(b), is amended by adding at the end the following:
“(y) In the case of a drug, device, or food–
“(1) the submission of a report or recommendation by a
person accredited under section 523 that is false or misleading
in any material respect;
“(2) the disclosure by a person accredited under section
523 of confidential commercial information or any trade secret
without the express written consent of the person who submitted
such information or secret to such person; or
“(3) the receipt by a person accredited under section 523
of a bribe in any form or the doing of any corrupt act by such
person associated with a responsibility delegated to such person
under this Act.”.
<> (d) Reports on Program of
Accreditation.–
(1) Comptroller general.–
(A) Implementation of program.–Not later than 5
years after the date of the enactment of this Act, the
Comptroller General of the United States shall submit to
the Committee on Commerce of the House of
Representatives and the Committee on Labor and Human
Resources of the Senate a report describing the extent
to which the program of accreditation required by the
amendment made by subsection (a) has been implemented.
(B) Evaluation of program.–Not later than 6 months
prior to the date on which, pursuant to subsection (c)
of section 523 of the Federal Food, Drug, and Cosmetic
Act (as added by subsection (a)), the authority provided
under subsection (a) of such section will terminate, the
Comptroller General shall submit to the Committee on
Commerce of the House of Representatives and the
Committee on Labor and Human Resources of the Senate a
report describing the use of accredited persons under
such section 523, including an evaluation of the extent
to which such use assisted the Secretary in carrying out
the duties of the Secretary under such Act with respect
to devices, and the extent to which such use promoted
actions which are contrary to the purposes of such Act.
(2) Inclusion of certain devices within program.–Not later
than 3 years after the date of the enactment of this Act, the
Secretary of Health and Human Services shall submit to the
Committee on Commerce of the House of Representatives and the
Committee on Labor and Human Resources of the Senate a report
providing a determination by the Secretary of whether, in the
program of accreditation established pursuant to the amendment
made by subsection (a), the limitation established in clause
(iii) of section 523(a)(3)(A) of the Federal Food, Drug, and
Cosmetic Act (relating to class II devices for which clinical
data are required in reports under section 510(k)) should be
removed.
SEC. 211. DEVICE TRACKING.
Effective 90 days after the date of the enactment of this Act,
section 519(e) (21 U.S.C. 360i(e)) is amended to read as follows:
“Device Tracking
“(e)(1) The Secretary may by order require a manufacturer to adopt
a method of tracking a class II or class III device–
“(A) the failure of which would be reasonably likely to
have serious adverse health consequences; or
“(B) which is–
“(i) intended to be implanted in the human body for
more than one year, or
“(ii) a life sustaining or life supporting device
used outside a device user facility.
“(2) Any patient receiving a device subject to tracking under
paragraph (1) may refuse to release, or refuse permission to release,
the patient’s name, address, social security number, or other
identifying information for the purpose of tracking.”.
SEC. 212. POSTMARKET SURVEILLANCE.
Effective 90 days after the date of the enactment of this Act,
section 522 (21 U.S.C. 360l) is amended to read as follows:
“Sec. 522. (a) In General.–The Secretary may by order require a
manufacturer to conduct postmarket surveillance for any device of the
manufacturer which is a class II or class III device the failure of
which would be reasonably likely to have serious adverse health
consequences or which is intended to be–
“(1) implanted in the human body for more than one year, or
“(2) a life sustaining or life supporting device used
outside a device user facility.
“(b) Surveillance Approval.–Each manufacturer required to conduct
a surveillance of a device shall, within 30 days of receiving an order
from the Secretary prescribing that the manufacturer is required under
this section to conduct such surveillance, submit, for the approval of
the Secretary, a plan for the required surveillance. The Secretary,
within 60 days of the receipt of such plan, shall determine if the
person designated to conduct the surveillance has appropriate
qualifications and experience to undertake such surveillance and if the
plan will result in the collection of useful data that can reveal
unforeseen adverse events or other information necessary to protect the
public health. The Secretary, in consultation with the manufacturer, may
by order require a prospective surveillance period of up to 36 months.
Any determination by the Secretary that a longer period is necessary
shall be made by mutual agreement between the Secretary and the
manufacturer or, if no agreement can be reached, after the completion of
a dispute resolution process as described in section 562.”.
SEC. 213. REPORTS.
(a) Reports.–Section 519 (21 U.S.C. 360i) is amended–
(1) in subsection (a)–
(A) in the matter preceding paragraph (1), by
striking “manufacturer, importer, or distributor” and
inserting “manufacturer or importer”;
(B) in paragraph (4), by striking “manufacturer,
importer, or distributor” and inserting “manufacturer or importer”;
(C) in paragraph (7), by adding “and” after the
semicolon at the end;
(D) in paragraph (8)–
(i) by striking “manufacturer, importer, or
distributor” each place such term appears and
inserting “manufacturer or importer”; and
(ii) by striking the semicolon at the end and
inserting a period;
(E) by striking paragraph (9); and
(F) by inserting at the end the following sentence:
“The Secretary shall by regulation require distributors
to keep records and make such records available to the
Secretary upon request. Paragraphs (4) and (8) apply to
distributors to the same extent and in the same manner
as such paragraphs apply to manufacturers and
importers.”;
(2) by striking subsection (d); and
(3) in subsection (f), by striking “, importer, or
distributor” each place it appears and inserting “or
importer”.
(b) Registration.–Section 510(g) (21 U.S.C. 360(g)) is amended–
(1) by redesignating paragraph (4) as paragraph (5);
(2) by inserting after paragraph (3) the following:
“(4) any distributor who acts as a wholesale distributor of
devices, and who does not manufacture, repackage, process, or
relabel a device; or”; and
(3) by adding at the end the following flush sentence:
“In this subsection, the term `wholesale distributor’ means any person
(other than the manufacturer or the initial importer) who distributes a
device from the original place of manufacture to the person who makes
the final delivery or sale of the device to the ultimate consumer or
user.”.
(c) Device User Facilities.–
(1) In general.–Section 519(b) (21 U.S.C. 360i(b)) is amended–
(A) in paragraph (1)(C)–
(i) in the first sentence, by striking “a
semi-annual basis” and inserting “an annual basis”;
(ii) in the second sentence, by striking “and July 1”; and
(iii) by striking the matter after and below clause (iv); and
(B) in paragraph (2)–
(i) in subparagraph (A), by inserting “or” after the comma at the end;
(ii) in subparagraph (B), by striking “, or” at the end and inserting a period; and
(iii) by striking subparagraph (C).
(2) Sentinel system.–Section 519(b) (21 U.S.C. 360i(b)) is amended–
(A) by redesignating paragraph (5) as paragraph (6);
and
(B) by inserting after paragraph (4) the following paragraph:
“(5) With respect to device user facilities:
“(A) The Secretary shall by regulation plan and implement a
program under which the Secretary limits user reporting under paragraphs (1) through (4) to a subset of user facilities
that constitutes a representative profile of user reports for
device deaths and serious illnesses or serious injuries.
“(B) During the period of planning the program under
subparagraph (A), paragraphs (1) through (4) continue to apply.
“(C) During the period in which the Secretary is providing
for a transition to the full implementation of the program,
paragraphs (1) through (4) apply except to the extent that the
Secretary determines otherwise.
“(D) On and after the date on which the program is fully
implemented, paragraphs (1) through (4) do not apply to a user
facility unless the facility is included in the subset referred
to in subparagraph (A).
“(E) Not later than 2 years after the date of the enactment
of the Food and Drug Administration Modernization Act of 1997,
the Secretary shall submit to the Committee on Commerce of the
House of Representatives, and to the Committee on Labor and
Human Resources of the Senate, a report describing the plan
developed by the Secretary under subparagraph (A) and the
progress that has been made toward the implementation of the
plan.”.
SEC. 214. PRACTICE OF MEDICINE.
Chapter IX is amended by adding at the end the following:
<> “SEC. 906. PRACTICE OF MEDICINE.
“Nothing in this Act shall be construed to limit or interfere with
the authority of a health care practitioner to prescribe or administer
any legally marketed device to a patient for any condition or disease
within a legitimate health care practitioner-patient relationship. This
section shall not limit any existing authority of the Secretary to
establish and enforce restrictions on the sale or distribution, or in
the labeling, of a device that are part of a determination of
substantial equivalence, established as a condition of approval, or
promulgated through regulations. Further, this section shall not change
any existing prohibition on the promotion of unapproved uses of legally
marketed devices.”.
SEC. 215. NONINVASIVE BLOOD GLUCOSE METER.
(a) Findings.–The Congress finds that–
(1) diabetes and its complications are a leading cause of
death by disease in America;
(2) diabetes affects approximately 16,000,000 Americans and
another 650,000 will be diagnosed in 1997;
(3) the total health care-related costs of diabetes total
nearly $100,000,000,000 per year;
(4) diabetes is a disease that is managed and controlled on
a daily basis by the patient;
(5) the failure to properly control and manage diabetes
results in costly and often fatal complications including but
not limited to blindness, coronary artery disease, and kidney
failure;
(6) blood testing devices are a critical tool for the
control and management of diabetes, and existing blood testing
devices require repeated piercing of the skin;
(7) the pain associated with existing blood testing devices
creates a disincentive for people with diabetes to test blood
glucose levels, particularly children;
(8) a safe and effective noninvasive blood glucose meter
would likely improve control and management of diabetes by
increasing the number of tests conducted by people with
diabetes, particularly children; and
(9) the Food and Drug Administration is responsible for
reviewing all applications for new medical devices in the United
States.
(b) Sense of Congress.–It is the sense of the Congress that the
availability of a safe, effective, noninvasive blood glucose meter would
greatly enhance the health and well-being of all people with diabetes
across America and the world.
SEC. 216. USE OF DATA RELATING TO PREMARKET APPROVAL; PRODUCT
DEVELOPMENT PROTOCOL.
(a) Use of Data Relating to Premarket Approval.–
(1) In general.–Section 520(h)(4) (21 U.S.C. 360j(h)(4)) is amended to read as follows:
“(4)(A) Any information contained in an application for premarket
approval filed with the Secretary pursuant to section 515(c) (including
information from clinical and preclinical tests or studies that
demonstrate the safety and effectiveness of a device, but excluding
descriptions of methods of manufacture and product composition and other
trade secrets) shall be available, 6 years after the application has
been approved by the Secretary, for use by the Secretary in–
“(i) approving another device;
“(ii) determining whether a product development protocol
has been completed, under section 515 for another device;
“(iii) establishing a performance standard or special
control under this Act; or
“(iv) classifying or reclassifying another device under
section 513 and subsection (l)(2).
“(B) The publicly available detailed summaries of information
respecting the safety and effectiveness of devices required by paragraph
(1)(A) shall be available for use by the Secretary as the evidentiary
basis for the agency actions described in subparagraph (A).”.
(2) Conforming amendments.–Section 517(a) (21 U.S.C.
360g(a)) is amended–
(A) in paragraph (8), by adding “or” at the end;
(B) in paragraph (9), by striking “, or” and
inserting a comma; and
(C) by striking paragraph (10).
(b) Product Development Protocol.–Section 515(f)(2) (21 U.S.C.
360e(f)(2)) is amended by striking “he shall” and all that follows and
inserting the following: “the Secretary–
“(A) may, at the initiative of the Secretary, refer the
proposed protocol to the appropriate panel under section 513 for
its recommendation respecting approval of the protocol; or
“(B) shall so refer such protocol upon the request of the
submitter, unless the Secretary finds that the proposed protocol
and accompanying data which would be reviewed by such panel
substantially duplicate a product development protocol and
accompanying data which have previously been reviewed by such a
panel.”.
SEC. 217. CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL INVESTIGATIONS FOR APPROVAL.
Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) is amended by striking “clinical investigations” and inserting “1 or more clinical investigations”.
TITLE III–IMPROVING REGULATION OF FOOD
SEC. 301. FLEXIBILITY FOR REGULATIONS REGARDING CLAIMS.
Section 403(r) (21 U.S.C. 343(r)) is amended by adding at the end the following:
“(7) The Secretary may make proposed regulations issued under this
paragraph effective upon publication pending consideration of public
comment and publication of a final regulation if the Secretary
determines that such action is necessary–
“(A) to enable the Secretary to review and act promptly on petitions the Secretary determines provide for information necessary to–
“(i) enable consumers to develop and maintain healthy dietary practices;
“(ii) enable consumers to be informed promptly and
effectively of important new knowledge regarding
nutritional and health benefits of food; or
“(iii) ensure that scientifically sound nutritional
and health information is provided to consumers as soon
as possible; or
“(B) to enable the Secretary to act promptly to ban or modify a claimA Claim A claim is “factually unsustainable” where it could be said with confidence before trial that the factual basis for the claim is entirely without substance, which can be the case if it were clear beyond question that the facts pleaded are contradicted by all the documents or other material on which it is based. under this paragraph.
Such proposed regulations shall be deemed final agency action for purposes of judicial review.”.
SEC. 302. PETITIONS FOR CLAIMS.
Section 403(r)(4)(A)(i) (21 U.S.C. 343(r)(4)(A)(i)) is amended–
(1) by adding after the second sentence the following: “If
the Secretary does not act within such 100 days, the petition
shall be deemed to be denied unless an extension is mutually
agreed upon by the Secretary and the petitioner.”;
(2) in the fourth sentence (as amended by paragraph (1)) by
inserting immediately before the comma the following: “or the
petition is deemed to be denied”; and
(3) by adding at the end the following: “If the Secretary
does not act within such 90 days, the petition shall be deemed
to be denied unless an extension is mutually agreed upon by the
Secretary and the petitioner. If the Secretary issues a proposed
regulation, the rulemaking shall be completed within 540 days of
the date the petition is received by the Secretary. If the
Secretary does not issue a regulation within such 540 days, the
Secretary shall provide the Committee on Commerce of the House
of Representatives and the Committee on Labor and Human
Resources of the Senate the reasons action on the regulation did
not occur within such 540 days.”.
SEC. 303. HEALTH CLAIMS FOR FOOD PRODUCTS.
Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended by adding at the
end thereof the following:
“(C) Notwithstanding the provisions of clauses (A)(i) and (B), a
claim of the type described in subparagraph (1)(B) which is not
authorized by the Secretary in a regulation promulgated in accordance
with clause (B) shall be authorized and may be made with respect to a food if–
“(i) a scientific body of the United States Government with
official responsibility for public health protection or research
directly relating to human nutrition (such as the National
Institutes of Health or the Centers for Disease Control and
Prevention) or the National Academy of Sciences or any of its
subdivisions has published an authoritative statement, which is
currently in effect, about the relationship between a nutrient
and a disease or health-related condition to which the claim refers;
“(ii) a person has submitted to the Secretary, at least 120
days (during which the Secretary may notify any person who is
making a claim as authorized by clause (C) that such person has
not submitted all the information required by such clause)
before the first introduction into interstate commerce of the
food with a label containing the claim, (I) a notice of the
claim, which shall include the exact words used in the claim and
shall include a concise description of the basis upon which such
person relied for determining that the requirements of subclause
(i) have been satisfied, (II) a copy of the statement referred
to in subclause (i) upon which such person relied in making the
claim, and (III) a balanced representation of the scientific
literature relating to the relationship between a nutrient and a
disease or health-related condition to which the claim refers;
“(iii) the claim and the food for which the claim is made
are in compliance with clause (A)(ii) and are otherwise in
compliance with paragraph (a) and section 201(n); and
“(iv) the claim is stated in a manner so that the claim is
an accurate representation of the authoritative statement
referred to in subclause (i) and so that the claim enables the
public to comprehend the information provided in the claim and
to understand the relative significance of such information in the context of a total daily diet.
For purposes of this clause, a statement shall be regarded as an authoritative statement of a scientific body described in subclause (i) only if the statement is published by the scientific body and shall not include a statement of an employee of the scientific body made in the
individual capacity of the employee.
“(D) A claim submitted under the requirements of clause (C) may be made until–
“(i) such time as the Secretary issues a regulation under
the standard in clause (B)(i)–
“(I) prohibiting or modifying the claim and the regulation has become effective, or
“(II) finding that the requirements of clause (C)
have not been met, including finding that the petitioner
has not submitted all the information required by such clause; or
“(ii) a district court of the United States in an
enforcement proceeding under chapter III has determined that the requirements of clause (C) have not been met.”.
SEC. 304. NUTRIENT CONTENT CLAIMS.
Section 403(r)(2) (21 U.S.C. 343(r)(2)) is amended by adding at the end the following:
“(G) A claim of the type described in subparagraph (1)(A) for a
nutrient, for which the Secretary has not promulgated a regulation under
clause (A)(i), shall be authorized and may be made with respect to a food if–
“(i) a scientific body of the United States Government with
official responsibility for public health protection or research
directly relating to human nutrition (such as the National
Institutes of Health or the Centers for Disease Control and
Prevention) or the National Academy of Sciences or any of its
subdivisions has published an authoritative statement, which is
currently in effect, which identifies the nutrient level to which the claim refers;
“(ii) a person has submitted to the Secretary, at least 120
days (during which the Secretary may notify any person who is
making a claim as authorized by clause (C) that such person has
not submitted all the information required by such clause)
before the first introduction into interstate commerce of the
food with a label containing the claim, (I) a notice of the
claim, which shall include the exact words used in the claim and
shall include a concise description of the basis upon which such
person relied for determining that the requirements of subclause
(i) have been satisfied, (II) a copy of the statement referred
to in subclause (i) upon which such person relied in making the
claim, and (III) a balanced representation of the scientific
literature relating to the nutrient level to which the claim refers;
“(iii) the claim and the food for which the claim is made are in compliance with clauses (A) and (B), and are otherwise in compliance with paragraph (a) and section 201(n); and
“(iv) the claim is stated in a manner so that the claim is
an accurate representation of the authoritative statement
referred to in subclause (i) and so that the claim enables the
public to comprehend the information provided in the claim and
to understand the relative significance of such information in the context of a total daily diet.
For purposes of this clause, a statement shall be regarded as an authoritative statement of a scientific body described in subclause (i) only if the statement is published by the scientific body and shall not include a statement of an employee of the scientific body made in the
individual capacity of the employee.
“(H) A claim submitted under the requirements of clause (G) may be
made until–
“(i) such time as the Secretary issues a regulation–
“(I) prohibiting or modifying the claim and the regulation has become effective, or
“(II) finding that the requirements of clause (G)
have not been met, including finding that the petitioner
had not submitted all the information required by such clause; or
“(ii) a district court of the United States in an
enforcement proceeding under chapter III has determined that the
requirements of clause (G) have not been met.”.
SEC. 305. REFERRAL STATEMENTS.
Section 403(r)(2)(B) (21 U.S.C. 343(r)(2)(B)) is amended to read as follows:
“(B) If a claim described in subparagraph (1)(A) is made with
respect to a nutrient in a food and the Secretary makes a determination
that the food contains a nutrient at a level that increases to persons
in the general population the risk of a disease or health-related
condition that is diet related, the label or labeling of such food shall
contain, prominently and in immediate proximity to such claim, the
following statement: `See nutrition information for ____ content.’ The
blank shall identify the nutrient associated with the increased disease
or health-related condition risk. In making the determination described
in this clause, the Secretary shall take into account the significance
of the food in the total daily diet.”.
SEC. 306. DISCLOSURE OF IRRADIATION.
Chapter IV (21 U.S.C. 341 et seq.) is amended by inserting after
section 403B the following:
“Sec. 403C. (a) No provision of section
201(n), 403(a), or 409 shall be construed to require on the label or
labeling of a food a separate radiation disclosure statement that is
more prominent than the declaration of ingredients required by section 403(i)(2).
“(b) In this section, the term `radiation disclosure statement’
means a written statement that discloses that a food has been
intentionally subject to radiation.”.
SEC. 307. IRRADIATION PETITION.
Not later than 60 days following the date of the enactment of this
Act, the Secretary of Health and Human Services shall make a final
determination on any petition pending with the Food and Drug
Administration that would permit the irradiation of red meat under
section 409(b)(1) of the Federal Food, Drug, and Cosmetic Act. If the
Secretary does not make such determination, the Secretary shall, not
later than 60 days following the date of the enactment of this Act,
provide the Committee on Commerce of the House of Representatives and
the Committee on Labor and Human Resources of the Senate an explanation
of the process followed by the Food and Drug Administration in reviewing
the petition referred to in paragraph (1) and the reasons action on the
petition was delayed.
SEC. 308. GLASS AND CERAMIC WARE.
(a) In General.–The Secretary may not implement any requirement
which would ban, as an unapproved food additive, lead and cadmium based
enamel in the lip and rim area of glass and ceramic ware before the
expiration of one year after the date such requirement is published.
(b) Lead and Cadmium Based Enamel.–Unless the Secretary determines,
based on available data, that lead and cadmium based enamel on glass and
ceramic ware–
(1) which has less than 60 millimeters of decorating area
below the external rim, and
(2) which is not, by design, representation, or custom of
usage intended for use by children,is unsafe, the Secretary shall not take any action before January 1,
2003, to ban lead and cadmium based enamel on such glass and ceramic
ware. Any action taken after January 1, 2003, to ban such enamel on such
glass and ceramic ware as an unapproved food additive shall be taken by
regulation and such regulation shall provide that such products shall
not be removed from the market before 1 year after publication of the final regulation.
SEC. 309. FOOD CONTACT SUBSTANCES.
(a) Food Contact Substances.–Section 409(a) (21 U.S.C. 348(a)) is amended–
(1) in paragraph (1)–
(A) by striking “subsection (i)” and inserting “subsection (j)”; and
(B) by striking at the end “or”;
(2) by striking the period at the end of paragraph (2) and
inserting “; or”;
(3) by inserting after paragraph (2) the following:
“(3) in the case of a food additive as defined in this Act
that is a food contact substance, there is–
“(A) in effect, and such substance and the use of
such substance are in conformity with, a regulation
issued under this section prescribing the conditions
under which such additive may be safely used; or
“(B) a notification submitted under subsection (h)
that is effective.”; and
(4) by striking the matter following paragraph (3) (as added
by paragraph (3)) and inserting the following flush sentence:
“While such a regulation relating to a food additive, or such a
notification under subsection (h)(1) relating to a food additive that is
a food contact substance, is in effect, and has not been revoked
pursuant to subsection (i), a food shall not, by reason of bearing or
containing such a food additive in accordance with the regulation or
notification, be considered adulterated under section 402(a)(1).”.
(b) Notification for Food Contact Substances.–Section 409 (21
U.S.C. 348), as amended by subsection (a), is further amended–
(1) by redesignating subsections (h) and (i), as subsections
(i) and (j), respectively;
(2) by inserting after subsection (g) the following:
“Notification Relating to a Food Contact Substance
“(h)(1) Subject to such regulations as may be promulgated under
paragraph (3), a manufacturer or supplier of a food contact substance
may, at least 120 days prior to the introduction or delivery for
introduction into interstate commerce of the food contact substance,
notify the Secretary of the identity and intended use of the food
contact substance, and of the determination of the manufacturer or
supplier that the intended use of such food contact substance is safe
under the standard described in subsection (c)(3)(A). The notification
shall contain the information that forms the basis of the determination
and all information required to be submitted by regulations promulgated
by the Secretary.
“(2)(A) A notification submitted under paragraph (1) shall become
effective 120 days after the date of receipt by the Secretary and the
food contact substance may be introduced or delivered for introduction
into interstate commerce, unless the Secretary makes a determination within the 120-day period that, based on the data
and information before the Secretary, such use of the food contact
substance has not been shown to be safe under the standard described in
subsection (c)(3)(A), and informs the manufacturer or supplier of such determination.
“(B) A decision by the Secretary to object to a notification shall
constitute final agency action subject to judicial review.
“(C) In this paragraph, the term `food contact substance’ means the
substance that is the subject of a notification submitted under
paragraph (1), and does not include a similar or identical substance
manufactured or prepared by a person other than the manufacturer
identified in the notification.
“(3)(A) The process in this subsection shall be utilized for
authorizing the marketing of a food contact substance except where the
Secretary determines that submission and review of a petition under
subsection (b) is necessary to provide adequate assurance of safety, or
where the Secretary and any manufacturer or supplier agree that such
manufacturer or supplier may submit a petition under subsection (b).
“(B) The Secretary is authorized to promulgate regulations to
identify the circumstances in which a petition shall be filed under
subsection (b), and shall consider criteria such as the probable
consumption of such food contact substance and potential toxicity of the
food contact substance in determining the circumstances in which a
petition shall be filed under subsection (b).
“(4) The Secretary shall keep confidential any information provided
in a notification under paragraph (1) for 120 days after receipt by the
Secretary of the notification. After the expiration of such 120 days,
the information shall be available to any interested party except for
any matter in the notification that is a trade secret or confidential
commercial information.
“(5)(A)(i) Except as provided in clause (ii), the notification
program established under this subsection shall not operate in any
fiscal year unless–
“(I) an appropriation equal to or exceeding the applicable
amount under clause (iv) is made for such fiscal year for
carrying out such program in such fiscal year; and
“(II) the Secretary certifies that the amount appropriated
for such fiscal year for the Center for Food Safety and Applied
Nutrition of the Food and Drug Administration (exclusive of the
appropriation referred to in subclause (I)) equals or exceeds
the amount appropriated for the Center for fiscal year 1997,
excluding any amount appropriated for new programs.
“(ii) The Secretary shall, not later than April 1, 1999, begin
accepting and reviewing notifications submitted under the notification
program established under this subsection if–
“(I) an appropriation equal to or exceeding the applicable
amount under clause (iii) is made for the last six months of
fiscal year 1999 for carrying out such program during such
period; and
“(II) the Secretary certifies that the amount appropriated
for such period for the Center for Food Safety and Applied
Nutrition of the Food and Drug Administration (exclusive of the
appropriation referred to in subclause (I)) equals or exceeds an
amount equivalent to one-half the amount appropriated for the
Center for fiscal year 1997, excluding any amount appropriated
for new programs.
“(iii) For the last six months of fiscal year 1999, the applicable
amount under this clause is $1,500,000, or the amount specified in the
budget request of the President for the six-month period involved for
carrying out the notification program in fiscal year 1999, whichever is less.
“(iv) For fiscal year 2000 and subsequent fiscal years, the
applicable amount under this clause is $3,000,000, or the amount
specified in the budget request of the President for the fiscal year
involved for carrying out the notification program under this
subsection, whichever is less.
“(B) For purposes of carrying out the notification program under
this subsection, there are authorized to be appropriated such sums as
may be necessary for each of the fiscal years 1999 through fiscal year
2003, except that such authorization of appropriations is not effective
for a fiscal year for any amount that is less than the applicable amount
under clause (iii) or (iv) of subparagraph (A), whichever is applicable.
“(C) Not later than April 1 of fiscal year 1998 and February 1 of
each subsequent fiscal year, the Secretary shall submit a report to the
Committees on Appropriations of the House of Representatives and the
Senate, the Committee on Commerce of the House of Representatives, and
the Committee on Labor and Human Resources of the Senate that provides
an estimate of the Secretary of the costs of carrying out the
notification program established under this subsection for the next fiscal year.
“(6) In this section, the term `food contact substance’ means any
substance intended for use as a component of materials used in
manufacturing, packing, packaging, transporting, or holding food if such
use is not intended to have any technical effect in such food.”;
(3) in subsection (i), as so redesignated by paragraph (1),
by adding at the end the following: “The Secretary shall by
regulation prescribe the procedure by which the Secretary may
deem a notification under subsection (h) to no longer be
effective.”; and
(4) in subsection (j), as so redesignated by paragraph (1),
by striking “subsections (b) to (h)” and inserting “subsections (b) to (i)”.
TITLE IV–GENERAL PROVISIONS
SEC. 401. DISSEMINATION OF INFORMATION ON NEW USES.
(a) In General.–Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after subchapter C the following:
“Subchapter D–Dissemination of Treatment Information
“SEC. 551. REQUIREMENTS FOR DISSEMINATION OF TREATMENT INFORMATION
ON DRUGS OR DEVICES.
“(a) In General.–Notwithstanding sections 301(d), 502(f), and 505,
and section 351 of the Public Health Service Act (42 U.S.C. 262), a
manufacturer may disseminate to–
“(1) a health care practitioner;
“(2) a pharmacy benefit manager;
“(3) a health insurance issuer;
“(4) a group health plan; or
“(5) a Federal or State governmental agency;
written information concerning the safety, effectiveness, or benefit of
a use not described in the approved labeling of a drug or device if the
manufacturer meets the requirements of subsection (b).
“(b) Specific Requirements.–A manufacturer may disseminate
information under subsection (a) on a new use only if–
“(1)(A) in the case of a drug, there is in effect for the
drug an application filed under subsection (b) or (j) of section
505 or a biologics license issued under section 351 of the
Public Health Service Act; or
“(B) in the case of a device, the device is being
commercially distributed in accordance with a regulation under
subsection (d) or (e) of section 513, an order under subsection
(f) of such section, or the approval of an application under
section 515;
“(2) the information meets the requirements of section 552;
“(3) the information to be disseminated is not derived from
clinical research conducted by another manufacturer or if it was
derived from research conducted by another manufacturer, the
manufacturer disseminating the information has the permission of
such other manufacturer to make the dissemination;
“(4) the manufacturer has, 60 days before such
dissemination, submitted to the Secretary–
“(A) a copy of the information to be disseminated;
and
“(B) any clinical trial information the
manufacturer has relating to the safety or effectiveness
of the new use, any reports of clinical experience
pertinent to the safety of the new use, and a summary of
such information;
“(5) the manufacturer has complied with the requirements of
section 554 (relating to a supplemental application for such
use);
“(6) the manufacturer includes along with the information
to be disseminated under this subsection–
“(A) a prominently displayed statement that
discloses–
“(i) that the information concerns a use of a
drug or device that has not been approved or
cleared by the Food and Drug Administration;
“(ii) if applicable, that the information is
being disseminated at the expense of the
manufacturer;
“(iii) if applicable, the name of any authors
of the information who are employees of,
consultants to, or have received compensation
from, the manufacturer, or who have a significant
financial interest in the manufacturer;
“(iv) the official labeling for the drug or
device and all updates with respect to the
labeling;
“(v) if applicable, a statement that there
are products or treatments that have been approved
or cleared for the use that is the subject of the
information being disseminated pursuant to
subsection (a)(1); and
“(vi) the identification of any person that
has provided funding for the conduct of a study
relating to the new use of a drug or device for
which such information is being disseminated; and
“(B) a bibliography of other articles from a scientific reference publication or scientific or
medical journal that have been previously published about the use of the drug or device covered by the information disseminated (unless the information already includes such
bibliography).
“(c) Additional Information.–If the Secretary determines, after
providing notice of such determination and an opportunity for a meeting
with respect to such determination, that the information submitted by a
manufacturer under subsection (b)(3)(B), with respect to the use of a
drug or device for which the manufacturer intends to disseminate
information, fails to provide data, analyses, or other written matter
that is objective and balanced, the Secretary may require the
manufacturer to disseminate–
“(1) additional objective and scientifically sound
information that pertains to the safety or effectiveness of the
use and is necessary to provide objectivity and balance,
including any information that the manufacturer has submitted to
the Secretary or, where appropriate, a summary of such
information or any other information that the Secretary has
authority to make available to the public; and
“(2) an objective statement of the Secretary, based on data
or other scientifically sound information available to the
Secretary, that bears on the safety or effectiveness of the new
use of the drug or device.
“SEC. 552. INFORMATION AUTHORIZED TO BE DISSEMINATED.
“(a) Authorized Information.–A manufacturer may disseminate
information under section 551 on a new use only if the information–
“(1) is in the form of an unabridged–
“(A) reprint or copy of an article, peer-reviewed
by experts qualified by scientific training or
experience to evaluate the safety or effectiveness of
the drug or device involved, which was published in a
scientific or medical journal (as defined in section
556(5)), which is about a clinical investigation with
respect to the drug or device, and which would be
considered to be scientifically sound by such experts;
or
“(B) reference publication, described in subsection
(b), that includes information about a clinical
investigation with respect to the drug or device that
would be considered to be scientifically sound by
experts qualified by scientific training or experience
to evaluate the safety or effectiveness of the drug or
device that is the subject of such a clinical
investigation; and
“(2) is not false or misleading and would not pose a
significant risk to the public health.
“(b) Reference Publication.–A reference publication referred to in
subsection (a)(1)(B) is a publication that–
“(1) has not been written, edited, excerpted, or published
specifically for, or at the request of, a manufacturer of a drug
or device;
“(2) has not been edited or significantly influenced by
such a manufacturer;
“(3) is not solely distributed through such a manufacturer
but is generally available in bookstores or other distribution
channels where medical textbooks are sold;
“(4) does not focus on any particular drug or device of a
manufacturer that disseminates information under section 551 and does not have a primary focus on new uses of drugs or
devices that are marketed or under investigation by a
manufacturer supporting the dissemination of information; and
“(5) presents materials that are not false or misleading.
<> “SEC. 553. ESTABLISHMENT OF LIST OF
ARTICLES AND PUBLICATIONS DISSEMINATED
AND LIST OF PROVIDERS THAT RECEIVED
ARTICLES AND REFERENCE PUBLICATIONS.
“(a) In General.–A manufacturer may disseminate information under
section 551 on a new use only if the manufacturer prepares and submits
to the Secretary biannually–
“(1) a list containing the titles of the articles and
reference publications relating to the new use of drugs or
devices that were disseminated by the manufacturer to a person
described in section 551(a) for the 6-month period preceding the
date on which the manufacturer submits the list to the
Secretary; and
“(2) a list that identifies the categories of providers (as
described in section 551(a)) that received the articles and
reference publications for the 6-month period described in
paragraph (1).
“(b) Records.–A manufacturer that disseminates information under
section 551 shall keep records that may be used by the manufacturer
when, pursuant to section 555, such manufacturer is required to take
corrective action and shall be made available to the Secretary, upon
request, for purposes of ensuring or taking corrective action pursuant
to such section. Such records, at the Secretary’s discretion, may
identify the recipient of information provided pursuant to section 551
or the categories of such recipients.
<> “SEC. 554. REQUIREMENT REGARDING
SUBMISSION OF SUPPLEMENTAL APPLICATION
FOR NEW USE; EXEMPTION FROM REQUIREMENT.
“(a) In General.–A manufacturer may disseminate information under
section 551 on a new use only if–
“(1)(A) the manufacturer has submitted to the Secretary a
supplemental application for such use; or
“(B) the manufacturer meets the condition described in
subsection (b) or (c) (relating to a certification that the
manufacturer will submit such an application); or
“(2) there is in effect for the manufacturer an exemption
under subsection (d) from the requirement of paragraph (1).
“(b) Certification on Supplemental Application; Condition in Case
of Completed Studies.–For purposes of subsection (a)(1)(B), a
manufacturer may disseminate information on a new use if the
manufacturer has submitted to the Secretary an application containing a
certification that–
“(1) the studies needed for the submission of a
supplemental application for the new use have been completed;
and
“(2) the supplemental application will be submitted to the
Secretary not later than 6 months after the date of the initial
dissemination of information under section 551.
“(c) Certification on Supplemental Application; Condition in Case
of Planned Studies.–
“(1) In general.–For purposes of subsection (a)(1)(B), a
manufacturer may disseminate information on a new use if–
“(A) the manufacturer has submitted to the
Secretary an application containing–
“(i) a proposed protocol and schedule for
conducting the studies needed for the submission
of a supplemental application for the new use; and
“(ii) a certification that the supplemental
application will be submitted to the Secretary not
later than 36 months after the date of the initial
dissemination of information under section 551
(or, as applicable, not later than such date as
the Secretary may specify pursuant to an extension
under paragraph (3)); and
“(B) the Secretary has determined that the proposed
protocol is adequate and that the schedule for
completing such studies is reasonable.
“(2) Progress reports on studies.–A manufacturer that
submits to the Secretary an application under paragraph (1)
shall submit to the Secretary periodic reports describing the
status of the studies involved.
“(3) Extension of time regarding planned studies.–The
period of 36 months authorized in paragraph (1)(A)(ii) for the
completion of studies may be extended by the Secretary if–
“(A) the Secretary determines that the studies
needed to submit such an application cannot be completed
and submitted within 36 months; or
“(B) the manufacturer involved submits to the
Secretary a written request for the extension and the
Secretary determines that the manufacturer has acted
with due diligence to conduct the studies in a timely
manner, except that an extension under this subparagraph
may not be provided for more than 24 additional months.
“(d) Exemption From Requirement of Supplemental Application.–
“(1) In general.–For purposes of subsection (a)(2), a
manufacturer may disseminate information on a new use if–
“(A) the manufacturer has submitted to the
Secretary an application for an exemption from meeting
the requirement of subsection (a)(1); and
“(B)(i) the Secretary has approved the application
in accordance with paragraph (2); or
“(ii) the application is deemed under paragraph
(3)(A) to have been approved (unless such approval is
terminated pursuant to paragraph (3)(B)).
“(2) Conditions for approval.–The Secretary may approve an
application under paragraph (1) for an exemption if the
Secretary makes a determination described in subparagraph (A) or
(B), as follows:
“(A) The Secretary makes a determination that, for
reasons defined by the Secretary, it would be
economically prohibitive with respect to such drug or
device for the manufacturer to incur the costs necessary
for the submission of a supplemental application. In
making such determination, the Secretary shall consider
(in addition to any other considerations the Secretary
finds appropriate)–
“(i) the lack of the availability under law
of any period during which the manufacturer would
have exclusive marketing rights with respect to
the new use involved; and
“(ii) the size of the population expected to
benefit from approval of the supplemental
application.
“(B) The Secretary makes a determination that, for
reasons defined by the Secretary, it would be unethical
to conduct the studies necessary for the supplemental
application. In making such determination, the Secretary
shall consider (in addition to any other considerations
the Secretary finds appropriate) whether the new use
involved is the standard of medical careMedical Care Treatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by health care professionals. Also called best practice, standard of care, and standard therapy. for a health
condition.
“(3) Time for consideration of application; deemed
approval.–
“(A) In general.–The Secretary shall approve or
deny an application under paragraph (1) for an exemption
not later than 60 days after the receipt of the
application. If the Secretary does not comply with the
preceding sentence, the application is deemed to be
approved.
“(B) Termination of deemed approval.–If pursuant
to a deemed approval under subparagraph (A) a
manufacturer disseminates written information under
section 551 on a new use, the Secretary may at any time
terminate such approval and under section 555(b)(3)
order the manufacturer to cease disseminating the
information.
“(e) Requirements Regarding Applications.–Applications under this
section shall be submitted in the form and manner prescribed by the
Secretary.
<> “SEC. 555. CORRECTIVE ACTIONS; CESSATION OF
DISSEMINATION.
“(a) Postdissemination Data Regarding Safety and Effectiveness.–
“(1) Corrective actions.–With respect to data received by
the Secretary after the dissemination of information under
section 551 by a manufacturer has begun (whether received
pursuant to paragraph (2) or otherwise), if the Secretary
determines that the data indicate that the new use involved may
not be effective or may present a significant risk to public
health, the Secretary shall, after consultation with the
manufacturer, take such action regarding the dissemination of
the information as the Secretary determines to be appropriate
for the protection of the public health, which may include
ordering that the manufacturer cease the dissemination of the
information.
“(2) Responsibilities of manufacturers to submit data.–
After a manufacturer disseminates information under section 551,
the manufacturer shall submit to the Secretary a notification of
any additional knowledge of the manufacturer on clinical
research or other data that relate to the safety or
effectiveness of the new use involved. If the manufacturer is in
possession of the data, the notification shall include the
data. <> The Secretary shall by regulation
establish the scope of the responsibilities of manufacturers
under this paragraph, including such limits on the
responsibilities as the Secretary determines to be appropriate.
“(b) Cessation of Dissemination.–
“(1) Failure of manufacturer to comply with requirements.–
The Secretary may order a manufacturer to cease the
dissemination of information pursuant to section 551 if the Secretary determines that the information being disseminated does not comply with the requirements established in this
subchapter. Such an order may be issued only after the Secretary
has provided notice to the manufacturer of the intent of the
Secretary to issue the order and (unless paragraph (2)(B)
applies) has provided an opportunity for a meeting with respect
to such intent. If the failure of the manufacturer constitutes a
minor violation of this subchapter, the Secretary shall delay
issuing the order and provide to the manufacturer an opportunity
to correct the violation.
“(2) Supplemental applications.–The Secretary may order a
manufacturer to cease the dissemination of information pursuant
to section 551 if–
“(A) in the case of a manufacturer that has
submitted a supplemental application for a new use
pursuant to section 554(a)(1), the Secretary determines
that the supplemental application does not contain
adequate information for approval of the new use for
which the application was submitted;
“(B) in the case of a manufacturer that has
submitted a certification under section 554(b), the
manufacturer has not, within the 6-month period
involved, submitted the supplemental application
referred to in the certification; or
“(C) in the case of a manufacturer that has
submitted a certification under section 554(c) but has
not yet submitted the supplemental application referred
to in the certification, the Secretary determines, after
an informal hearing, that the manufacturer is not acting
with due diligence to complete the studies involved.
“(3) Termination of deemed approval of exemption regarding
supplemental applications.–If under section 554(d)(3) the
Secretary terminates a deemed approval of an exemption, the
Secretary may order the manufacturer involved to cease
disseminating the information. A manufacturer shall comply with
an order under the preceding sentence not later than 60 days
after the receipt of the order.
“(c) Corrective Actions by Manufacturers.–
“(1) In general.–In any case in which under this section
the Secretary orders a manufacturer to cease disseminating
information, the Secretary may order the manufacturer to take
action to correct the information that has been disseminated,
except as provided in paragraph (2).
“(2) Termination of deemed approval of exemption regarding
supplemental applications.–In the case of an order under
subsection (b)(3) to cease disseminating information, the
Secretary may not order the manufacturer involved to take action
to correct the information that has been disseminated unless the
Secretary determines that the new use described in the
information would pose a significant risk to the public health.
<> “SEC. 556. DEFINITIONS.
“For purposes of this subchapter:
“(1) The term `health care practitioner’ means a physician,
or other individual who is a provider of health care, who is
licensed under the law of a State to prescribe drugs or devices.
“(2) The terms `health insurance issuer’ and `group health
plan’ have the meaning given such terms under section 2791 of
the Public Health Service Act.
“(3) The term `manufacturer’ means a person who
manufactures a drug or device, or who is licensed by such person
to distribute or market the drug or device.
“(4) The term `new use’–
“(A) with respect to a drug, means a use that is
not included in the labeling of the approved drug; and
“(B) with respect to a device, means a use that is
not included in the labeling for the approved or cleared
device.
“(5) The term `scientific or medical journal’ means a
scientific or medical publication–
“(A) that is published by an organization–
“(i) that has an editorial board;
“(ii) that utilizes experts, who have
demonstrated expertise in the subject of an
article under review by the organization and who
are independent of the organization, to review and
objectively select, reject, or provide comments
about proposed articles; and
“(iii) that has a publicly stated policy, to
which the organization adheres, of full disclosure
of any conflict of interest or biases for all
authors or contributors involved with the journal
or organization;
“(B) whose articles are peer-reviewed and published
in accordance with the regular peer-review procedures of
the organization;
“(C) that is generally recognized to be of national
scope and reputation;
“(D) that is indexed in the Index Medicus of the
National Library of Medicine of the National Institutes
of Health; and
“(E) that is not in the form of a special
supplement that has been funded in whole or in part by
one or more manufacturers.
<> “SEC. 557. RULES OF CONSTRUCTION.
“(a) Unsolicited Request.–Nothing in section 551 shall be
construed as prohibiting a manufacturer from disseminating information
in response to an unsolicited request from a health care practitioner.
“(b) Dissemination of Information on Drugs or Devices Not Evidence
of Intended Use.–Notwithstanding subsection (a), (f), or (o) of section
502, or any other provision of law, the dissemination of information
relating to a new use of a drug or device, in accordance with section
551, shall not be construed by the Secretary as evidence of a new
intended use of the drug or device that is different from the intended
use of the drug or device set forth in the official labeling of the drug
or device. Such dissemination shall not be considered by the Secretary
as labeling, adulteration, or misbranding of the drug or device.
“(c) Patent Protection.–Nothing in section 551 shall affect patent
rights in any manner.
“(d) Authorization for Dissemination of Articles and Fees for
Reprints of Articles.–Nothing in section 551 shall be construed as
prohibiting an entity that publishes a scientific journal
[[Page 111 STAT. 2364]]
(as defined in section 556(5)) from requiring authorization from the
entity to disseminate an article published by such entity or charging
fees for the purchase of reprints of published articles from such
entity.”.
(b) Prohibited Act.–Section 301 (21 U.S.C. 331), as amended by
section 210, is amended by adding at the end the following:
“(z) The dissemination of information in violation of section
551.”.
<> (c) Regulations.–Not later than 1
year after the date of enactment of this Act, the Secretary of Health
and Human Services shall promulgate regulations to implement the
amendments made by this section.
<> (d) Effective Date.–The amendments
made by this section shall take effect 1 year after the date of
enactment of this Act, or upon the Secretary’s issuance of final
regulations pursuant to subsection (c), whichever is sooner.
<> (e) Sunset.–The amendments made by
this section cease to be effective September 30, 2006, or 7 years after
the date on which the Secretary promulgates the regulations described in
subsection (c), whichever is later.
<> (f) Studies and Reports.–
(1) General accounting office.–
(A) In general.–The Comptroller General of the
United States shall conduct a study to determine the
impact of subchapter D of chapter V of the Federal Food,
Drug, and Cosmetic Act, as added by this section, on the
resources of the Department of Health and Human
Services.
(B) Report.–Not later than January 1, 2002, the
Comptroller General of the United States shall prepare
and submit to the Committee on Labor and Human Resources
of the Senate and the Committee on Commerce of the House
of Representatives a report of the results of the study.
(2) Department of health and human services.–
(A) In general.–In order to assist Congress in
determining whether the provisions of such subchapter
should be extended beyond the termination date specified
in subsection (e), the Secretary of Health and Human
Services shall, in accordance with subparagraph (B),
arrange for the conduct of a study of the scientific
issues raised as a result of the enactment of such
subchapter including issues relating to–
(i) the effectiveness of such subchapter with
respect to the provision of useful scientific
information to health care practitioners;
(ii) the quality of the information being
disseminated pursuant to the provisions of such
subchapter;
(iii) the quality and usefulness of the
information provided, in accordance with such
subchapter, by the Secretary or by the
manufacturer at the request of the Secretary; and
(iv) the impact of such subchapter on research
in the area of new uses, indications, or dosages,
particularly the impact on pediatric indications
and rare diseases.
(3) Procedure for study.–
(A) In general.–The Secretary shall request the
Institute of Medicine of the National Academy of
Sciences to conduct the study required by paragraph (2),
and to prepare and submit the report required by
subparagraph (B), under an arrangement by which the
actual expenses incurred by the Institute of Medicine in
conducting the study and preparing the report will be
paid by the Secretary. If the Institute of Medicine is
unwilling to conduct the study under such an
arrangement, the Comptroller General of the United
States shall conduct such study.
(B) Report.–Not later than September 30, 2005, the
Institute of Medicine or the Comptroller General of the
United States, as appropriate, shall prepare and submit
to the Committee on Labor and Human Resources of the
Senate, the Committee on Commerce of the House of
Representatives, and the Secretary a report of the
results of the study required by paragraph (2). The
Secretary, after the receipt of the report, shall make
the report available to the public.
SEC. 402. EXPANDED ACCESS TO INVESTIGATIONAL THERAPIES AND DIAGNOSTICS.
Chapter V (21 U.S.C. 351 et seq.), as amended in section 401, is
further amended by adding at the end the following:
“Subchapter E–General Provisions Relating to Drugs and Devices
<> “SEC. 561. EXPANDED ACCESS TO UNAPPROVED
THERAPIES AND DIAGNOSTICS.
“(a) Emergency Situations.–The Secretary may, under appropriate
conditions determined by the Secretary, authorize the shipment of
investigational drugs or investigational devices for the diagnosis,
monitoring, or treatment of a serious disease or condition in emergency
situations.
“(b) Individual Patient Access to Investigational Products Intended
for Serious Diseases.–Any person, acting through a physician licensed
in accordance with State law, may request from a manufacturer or
distributor, and any manufacturer or distributor may, after complying
with the provisions of this subsection, provide to such physician an
investigational drug or investigational device for the diagnosis,
monitoring, or treatment of a serious disease or condition if–
“(1) the licensed physician determines that the person has
no comparable or satisfactory alternative therapy available to
diagnose, monitor, or treat the disease or condition involved,
and that the probable risk to the person from the
investigational drug or investigational device is not greater
than the probable risk from the disease or condition;
“(2) the Secretary determines that there is sufficient
evidence of safety and effectiveness to support the use of the
investigational drug or investigational device in the case
described in paragraph (1);
“(3) the Secretary determines that provision of the
investigational drug or investigational device will not
interfere with the initiation, conduct, or completion of
clinical investigations to support marketing approval; and
“(4) the sponsor, or clinical investigator, of the
investigational drug or investigational device submits to the
Secretary a clinical protocol consistent with the provisions of
section 505(i) or 520(g), including any regulations promulgated
under section 505(i) or 520(g), describing the use of the
investigational drug or investigational device in a single
patient or a small group of patients.
“(c) Treatment Investigational New Drug Applications and Treatment
Investigational Device Exemptions.–Upon submission by a sponsor or a
physician of a protocol intended to provide widespread access to an
investigational drug or investigational device for eligible patients
(referred to in this subsection as an `expanded access protocol’), the
Secretary shall permit such investigational drug or investigational
device to be made available for expanded access under a treatment
investigational new drug application or treatment investigational device
exemption if the Secretary determines that–
“(1) under the treatment investigational new drug
application or treatment investigational device exemption, the
investigational drug or investigational device is intended for
use in the diagnosis, monitoring, or treatment of a serious or
immediately life-threatening disease or condition;
“(2) there is no comparable or satisfactory alternative
therapy available to diagnose, monitor, or treat that stage of
disease or condition in the population of patients to which the
investigational drug or investigational device is intended to be
administered;
“(3)(A) the investigational drug or investigational device
is under investigation in a controlled clinical trial for the
use described in paragraph (1) under an investigational drug
application in effect under section 505(i) or investigational
device exemption in effect under section 520(g); or
“(B) all clinical trials necessary for approval of that use
of the investigational drug or investigational device have been
completed;
“(4) the sponsor of the controlled clinical trials is
actively pursuing marketing approval of the investigational drug
or investigational device for the use described in paragraph (1)
with due diligence;
“(5) in the case of an investigational drug or
investigational device described in paragraph (3)(A), the
provision of the investigational drug or investigational device
will not interfere with the enrollment of patients in ongoing
clinical investigations under section 505(i) or 520(g);
“(6) in the case of serious diseases, there is sufficient
evidence of safety and effectiveness to support the use
described in paragraph (1); and
“(7) in the case of immediately life-threatening diseases,
the available scientific evidence, taken as a whole, provides a
reasonable basis to conclude that the investigational drug or
investigational device may be effective for its intended use and
would not expose patients to an unreasonable and significant
risk of illness or injury.
A protocol submitted under this subsection shall be subject to the
provisions of section 505(i) or 520(g), including regulations
promulgated under section 505(i) or 520(g). The Secretary may inform
national, State, and local medical associations and societies, voluntary health associations, and other appropriate persons about the
availability of an investigational drug or investigational device under
expanded access protocols submitted under this subsection. The
information provided by the Secretary, in accordance with the preceding
sentence, shall be the same type of information that is required by
section 402(j)(3) of the Public Health Service Act.
“(d) Termination.–The Secretary may, at any time, with respect to
a sponsor, physician, manufacturer, or distributor described in this
section, terminate expanded access provided under this section for an
investigational drug or investigational device if the requirements under
this section are no longer met.
“(e) Definitions.–In this section, the terms `investigational
drug’, `investigational device’, `treatment investigational new drug
application’, and `treatment investigational device exemption’ shall
have the meanings given the terms in regulations prescribed by the
Secretary.”.
<> SEC. 403. APPROVAL OF SUPPLEMENTAL
APPLICATIONS FOR APPROVED PRODUCTS.
(a) Standards.–Not later than 180 days after the date of enactment
of this Act, the Secretary of Health and Human Services shall publish in
the Federal Register standards for the prompt review of supplemental
applications submitted for approved articles under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or section 351 of the
Public Health Service Act (42 U.S.C. 262).
(b) Guidance to Industry.–Not later than 180 days after the date of
enactment of this Act, the Secretary shall issue final guidances to
clarify the requirements for, and facilitate the submission of data to
support, the approval of supplemental applications for the approved
articles described in subsection (a). The guidances shall–
(1) clarify circumstances in which published matter may be
the basis for approval of a supplemental application;
(2) specify data requirements that will avoid duplication of
previously submitted data by recognizing the availability of
data previously submitted in support of an original application;
and
(3) define supplemental applications that are eligible for priority review.
(c) Responsibilities of Centers.–The Secretary shall designate an
individual in each center within the Food and Drug Administration
(except the Center for Food Safety and Applied Nutrition) to be responsible for–
(1) encouraging the prompt review of supplemental applications for approved articles; and
(2) working with sponsors to facilitate the development and submission of data to support supplemental applications.
(d) Collaboration.–The Secretary shall implement programs and
policies that will foster collaboration between the Food and Drug
Administration, the National Institutes of Health, professional medical
and scientific societies, and other persons, to identify published and
unpublished studies that may support a supplemental application, and to
encourage sponsors to make supplemental applications or conduct further
research in support of a supplemental application based, in whole or in
part, on such studies.
SEC. 404. DISPUTE RESOLUTION.
Subchapter E of chapter V, as added by section 402, is amended by
adding at the end the following:
<> “SEC. 562. DISPUTE RESOLUTION.
“If, regarding an obligation concerning drugs or devices under this
Act or section 351 of the Public Health Service Act, there is a
scientific controversy between the Secretary and a person who is a
sponsor, applicant, or manufacturer and no specific provision of the Act
involved, including a regulation promulgated under such Act, provides a
right of review of the matter in controversy, the Secretary shall, by
regulation, establish a procedure under which such sponsor, applicant,
or manufacturer may request a review of such controversy, including a
review by an appropriate scientific advisory panel described in section
505(n) or an advisory committee described in section 515(g)(2)(B). Any
such review shall take place in a timely manner. The Secretary shall
promulgate such regulations within 1 year after the date of the
enactment of the Food and Drug Administration Modernization Act of
1997.”.
SEC. 405. INFORMAL AGENCY STATEMENTS.
Section 701 (21 U.S.C. 371) is amended by adding at the end the
following:
“(h)(1)(A) The Secretary shall develop guidance documents with
public participation and ensure that information identifying the
existence of such documents and the documents themselves are made
available to the public both in written form and, as feasible, through
electronic means. Such documents shall not create or confer any rights
for or on any person, although they present the views of the Secretary
on matters under the jurisdictionJurisdiction Authority by which courts receive and decide cases. Limited Jurisdiction: the authority over only particular types of cases, or cases under a prescribed amount in controversy, or seeking only certain types of relief, the District Court is a court of limited jurisdiction. Original Jurisdiction: Jurisdiction of the first court to hear a case. of the Food and Drug Administration.
“(B) Although guidance documents shall not be binding on the
Secretary, the Secretary shall ensure that employees of the Food and
Drug Administration do not deviate from such guidances without
appropriate justification and supervisory concurrence. The Secretary
shall provide training to employees in how to develop and use guidance
documents and shall monitor the development and issuance of such
documents.
“(C) For guidance documents that set forth initial interpretations
of a statute or regulation, changes in interpretation or policy that are
of more than a minor nature, complex scientific issues, or highly
controversial issues, the Secretary shall ensure public participation
prior to implementation of guidance documents, unless the Secretary
determines that such prior public participation is not feasible or
appropriate. In such cases, the Secretary shall provide for public
comment upon implementation and take such comment into account.
“(D) For guidance documents that set forth existing practices or
minor changes in policy, the Secretary shall provide for public comment
upon implementation.
“(2) In developing guidance documents, the Secretary shall ensure
uniform nomenclature for such documents and uniform internal procedures
for approval of such documents. The Secretary shall ensure that guidance
documents and revisions of such documents are properly dated and
indicate the nonbinding nature of the documents. The Secretary shall
periodically review all guidance documents and, where appropriate,
revise such documents.
“(3) The Secretary, acting through the Commissioner, shall maintain
electronically and update and publish periodically in the Federal
Register a list of guidance documents. All such documents shall be made
available to the public.
“(4) The Secretary shall ensure that an effective appeals mechanism
is in place to address complaints that the Food and Drug Administration
is not developing and using guidance documents in accordance with this
subsection.
<> “(5) Not later than July 1, 2000, the
Secretary after evaluating the effectiveness of the Good Guidance
Practices document, published in the Federal Register at 62 Fed. Reg.
8961, shall promulgate a regulation consistent with this subsection
specifying the policies and procedures of the Food and Drug
Administration for the development, issuance, and use of guidance
documents.”.
SEC. 406. FOOD AND DRUG ADMINISTRATION MISSION AND ANNUAL REPORT.
(a) Mission.–Section 903 (21 U.S.C. 393) is amended–
(1) by redesignating subsections (b) and (c) as subsections
(d) and (e), respectively; and
(2) by inserting after subsection (a) the following:
“(b) Mission.–The Administration shall–
“(1) promote the public health by promptly and efficiently
reviewing clinical research and taking appropriate action on the
marketing of regulated products in a timely manner;
“(2) with respect to such products, protect the public
health by ensuring that–
“(A) foods are safe, wholesome, sanitary, and
properly labeled;
“(B) human and veterinary drugs are safe and
effective;
“(C) there is reasonable assurance of the safety
and effectiveness of devices intended for human use;
“(D) cosmetics are safe and properly labeled; and
“(E) public health and safety are protected from
electronic product radiation;
“(3) participate through appropriate processes with
representatives of other countries to reduce the burden of
regulation, harmonize regulatory requirements, and achieve
appropriate reciprocal arrangements; and
“(4) as determined to be appropriate by the Secretary,
carry out paragraphs (1) through (3) in consultation with
experts in science, medicine, and public health, and in
cooperation with consumers, users, manufacturers, importers,
packers, distributors, and retailers of regulated products.”.
(b) Annual Report.–Section 903 (21 U.S.C. 393), as amended by
subsection (a), is further amended by adding at the end the following:
“(f) Agency Plan for Statutory Compliance.–
<> “(1) In
general.–Not later than 1 year after the date of enactment of
the Food and Drug Administration Modernization Act of 1997, the
Secretary, after consultation with appropriate scientific and
academic experts, health care professionals, representatives of
patient and consumer advocacy groups, and the regulated
industry, shall develop and publish in the Federal Register a
plan bringing the Secretary into compliance with each of the
obligations of the Secretary under this Act. The Secretary shall review the plan biannually and shall revise the
plan as necessary, in consultation with such persons.
“(2) Objectives of agency plan.–The plan required by
paragraph (1) shall establish objectives and mechanisms to
achieve such objectives, including objectives related to–
“(A) maximizing the availability and clarity of
information about the process for review of applications
and submissions (including petitions, notifications, and
any other similar forms of request) made under this Act;
“(B) maximizing the availability and clarity of
information for consumers and patients concerning new
products;
“(C) implementing inspection and postmarket
monitoring provisions of this Act;
“(D) ensuring access to the scientific and
technical expertise needed by the Secretary to meet
obligations described in paragraph (1);
“(E) establishing mechanisms, by July 1, 1999, for
meeting the time periods specified in this Act for the
review of all applications and submissions described in
subparagraph (A) and submitted after the date of
enactment of the Food and Drug Administration
Modernization Act of 1997; and
“(F) eliminating backlogs in the review of
applications and submissions described in subparagraph
(A), by January 1, 2000.
<> “(g) Annual Report.–The
Secretary shall annually prepare and publish in the Federal Register and
solicit public comment on a report that–
“(1) provides detailed statistical information on the
performance of the Secretary under the plan described in
subsection (f);
“(2) compares such performance of the Secretary with the
objectives of the plan and with the statutory obligations of the
Secretary; and
“(3) identifies any regulatory policy that has a
significant negative impact on compliance with any objective of
the plan or any statutory obligation and sets forth any proposed
revision to any such regulatory policy.”.
SEC. 407. INFORMATION SYSTEM.
(a) Amendment.–Chapter VII (21 U.S.C. 371 et seq.) is amended by
adding at the end the following:
“Subchapter D–Information and Education
<> “SEC. 741. INFORMATION SYSTEM.
“The Secretary shall establish and maintain an information system
to track the status and progress of each application or submission
(including a petition, notification, or other similar form of request)
submitted to the Food and Drug Administration requesting agency
action.”.
<> (b) Report.–Not later than 1 year
after the date of enactment of this Act, the Secretary of Health and
Human Services shall submit a report to the Committee on Labor and Human
Resources of the Senate and the Committee on Commerce of the House of
Representatives on the status of the system to be established under the amendment made by subsection (a), including the projected costs of
the system and concerns about confidentiality.
SEC. 408. EDUCATION AND TRAINING.
(a) Food and Drug Administration.–Chapter VII (21 U.S.C. 371 et
seq.), as amended by section 407, is further amended by adding at the
end the following section:
<> “SEC. 742. EDUCATION.
“(a) In General.–The Secretary shall conduct training and
education programs for the employees of the Food and Drug Administration
relating to the regulatory responsibilities and policies established by
this Act, including programs for–
“(1) scientific training;
“(2) training to improve the skill of officers and
employees authorized to conduct inspections under section 704;
“(3) training to achieve product specialization in such
inspections; and
“(4) training in administrative process and procedure and
integrity issues.
“(b) Intramural Fellowships and Other Training Programs.–The
Secretary, acting through the Commissioner, may, through fellowships and
other training programs, conduct and support intramural research
training for predoctoral and postdoctoral scientists and physicians.”.
(b) Centers for Disease Control and Prevention.–
(1) In general.–Part B of title III of the Public Health
Service Act is amended by inserting after section 317F (42
U.S.C. 247b-7) the following:
<> “SEC. 317G. FELLOWSHIP AND TRAINING PROGRAMS.
“The Secretary, acting through the Director of the Centers for
Disease Control and Prevention, shall establish fellowship and training
programs to be conducted by such Centers to train individuals to develop
skills in epidemiology, surveillance, laboratory analysis, and other
disease detection and prevention methods. Such programs shall be
designed to enable health professionals and health personnel trained
under such programs to work, after receiving such training, in local,
State, national, and international efforts toward the prevention and
control of diseases, injuries, and disabilities. Such fellowships and
training may be administered through the use of either appointment or
nonappointment procedures.”.
<> (2) Effective date.–The
amendment made by this subsection is deemed to have taken effect
July 1, 1995.
SEC. 409. CENTERS FOR EDUCATION AND RESEARCH ON THERAPEUTICS.
Title IX of the Public Health Service Act (42 U.S.C. 299 et seq.) is
amended by adding at the end of part A the following new section:
<> “SEC. 905. DEMONSTRATION PROGRAM
REGARDING CENTERS FOR EDUCATION AND
RESEARCH ON THERAPEUTICS.
“(a) In General.–The Secretary, acting through the Administrator
and in consultation with the Commissioner of Food and Drugs, shall
establish a demonstration program for the purpose of making one or more
grants for the establishment and operation of one or more centers to carry out the activities specified in
subsection (b).
“(b) Required Activities.–The activities referred to in subsection
(a) are the following:
“(1) The conduct of state-of-the-art clinical and
laboratory research for the following purposes:
“(A) To increase awareness of–
“(i) new uses of drugs, biological products,
and devices;
“(ii) ways to improve the effective use of
drugs, biological products, and devices; and
“(iii) risks of new uses and risks of
combinations of drugs and biological products.
“(B) To provide objective clinical information to
the following individuals and entities:
“(i) Health care practitioners or other
providers of health care goods or services.
“(ii) Pharmacy benefit managers.
“(iii) Health maintenance organizations or
other managed health care organizations.
“(iv) Health care insurers or governmental
agencies.
“(v) Consumers.
“(C) To improve the quality of health care while
reducing the cost of health care through–
“(i) the appropriate use of drugs, biological
products, or devices; and
“(ii) the prevention of adverse effects of
drugs, biological products, and devices and the
consequences of such effects, such as unnecessary
hospitalizations.
“(2) The conduct of research on the comparative
effectiveness and safety of drugs, biological products, and
devices.
“(3) Such other activities as the Secretary determines to
be appropriate, except that the grant may not be expended to
assist the Secretary in the review of new drugs.
“(c) Application for Grant.–A grant under subsection (a) may be
made only if an application for the grant is submitted to the Secretary
and the application is in such form, is made in such manner, and
contains such agreements, assurances, and information as the Secretary
determines to be necessary to carry out this section.
“(d) Peer Review.–A grant under subsection (a) may be made only if
the application for the grant has undergone appropriate technical and
scientific peer review.
“(e) Authorization of Appropriations.–For the purpose of carrying
out this section, there are authorized to be appropriated $2,000,000 for
fiscal year 1998, and $3,000,000 for each of fiscal years 1999 through
2002.”.
SEC. 410. MUTUAL RECOGNITION AGREEMENTS AND GLOBAL HARMONIZATION.
(a) Good Manufacturing Practice Requirements.–Section 520(f)(1)(B)
(21 U.S.C. 360j(f)(1)(B)) is amended–
(1) in clause (i), by striking “, and” at the end and
inserting a semicolon;
(2) in clause (ii), by striking the period and inserting “;
and”; and
(3) by inserting after clause (ii) the following:
“(iii) ensure that such regulation conforms, to the extent
practicable, with internationally recognized standards defining
quality systems, or parts of the standards, for medical
devices.”.
(b) Harmonization Efforts.–Section 803 (21 U.S.C. 383) is amended
by adding at the end the following:
“(c)(1) The Secretary shall support the Office of the United States
Trade Representative, in consultation with the Secretary of Commerce, in
meetings with representatives of other countries to discuss methods and
approaches to reduce the burden of regulation and harmonize regulatory
requirements if the Secretary determines that such harmonization
continues consumer protections consistent with the purposes of this Act.
“(2) The Secretary shall support the Office of the United States
Trade Representative, in consultation with the Secretary of Commerce, in
efforts to move toward the acceptance of mutual recognition agreements
relating to the regulation of drugs, biological products, devices,
foods, food additives, and color additives, and the regulation of good
manufacturing practices, between the European Union and the United
States.
“(3) The Secretary shall regularly participate in meetings with
representatives of other foreign governments to discuss and reach
agreement on methods and approaches to harmonize regulatory
requirements.
“(4) The Secretary shall, not later than 180 days after the date of
enactment of the Food and Drug Administration Modernization Act of 1997,
make public a plan that establishes a framework for achieving mutual
recognition of good manufacturing practices inspections.
“(5) Paragraphs (1) through (4) shall not apply with respect to
products defined in section 201(ff).”.
SEC. 411. ENVIRONMENTAL IMPACT REVIEW.
Chapter VII (21 U.S.C. 371 et seq.), as amended by section 407, is
further amended by adding at the end the following:
“Subchapter E–Environmental Impact Review
<> “SEC. 746. ENVIRONMENTAL IMPACT.
“Notwithstanding any other provision of law, an environmental
impact statement prepared in accordance with the regulations published
in part 25 of title 21, Code of Federal Regulations (as in effect on
August 31, 1997) in connection with an action carried out under (or a
recommendation or report relating to) this Act, shall be considered to
meet the requirements for a detailed statement under section 102(2)(C)
of the National Environmental Policy Act of 1969 (42 U.S.C.
4332(2)(C)).”.
SEC. 412. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND
COSMETICS.
(a) Nonprescription Drugs.–Chapter VII (21 U.S.C. 371 et seq.), as
amended by section 411, is further amended by adding at the end the
following:
[[Page 111 STAT. 2374]]
“Subchapter F–National Uniformity for Nonprescription Drugs and
Preemption for Labeling or Packaging of Cosmetics
<> “SEC. 751. NATIONAL UNIFORMITY FOR
NONPRESCRIPTION DRUGS.
“(a) In General.–Except as provided in subsection (b), (c)(1),
(d), (e), or (f), no State or political subdivision of a State may
establish or continue in effect any requirement–
“(1) that relates to the regulation of a drug that is not
subject to the requirements of section 503(b)(1) or
503(f)(1)(A); and
“(2) that is different from or in addition to, or that is
otherwise not identical with, a requirement under this Act, the
Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et
seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et
seq.).
“(b) Exemption.–
“(1) In general.–Upon application of a State or political
subdivision thereof, the Secretary may by regulation, after
notice and opportunity for written and oral presentation of
views, exempt from subsection (a), under such conditions as may
be prescribed in such regulation, a State or political
subdivision requirement that–
“(A) protects an important public interest that
would otherwise be unprotected, including the health and
safety of children;
“(B) would not cause any drug to be in violation of
any applicable requirement or prohibition under Federal
law; and
“(C) would not unduly burden interstate commerce.
“(2) Timely action.–The Secretary shall make a decision on
the exemption of a State or political subdivision requirement
under paragraph (1) not later than 120 days after receiving the
application of the State or political subdivision under
paragraph (1).
“(c) Scope.–
“(1) In general.–This section shall not apply to–
“(A) any State or political subdivision requirement
that relates to the practice of pharmacy; or
“(B) any State or political subdivision requirement
that a drug be dispensed only upon the prescription of a
practitioner licensed by law to administer such drug.
“(2) Safety or effectiveness.–For purposes of subsection
(a), a requirement that relates to the regulation of a drug
shall be deemed to include any requirement relating to public
information or any other form of public communication relating
to a warning of any kind for a drug.
“(d) Exceptions.–
“(1) In general.–In the case of a drug described in
subsection (a)(1) that is not the subject of an application
approved under section 505 or section 507 (as in effect on the
day before the date of enactment of the Food and Drug
Administration Modernization Act of 1997) or a final regulation
promulgated by the Secretary establishing conditions under which
the drug is generally recognized as safe and effective and not
misbranded, subsection (a) shall apply only with respect to a
requirement of a State or political subdivision of a State that relates to the same subject as, but is different from or in
addition to, or that is otherwise not identical with–
“(A) a regulation in effect with respect to the
drug pursuant to a statute described in subsection
(a)(2); or
“(B) any other requirement in effect with respect
to the drug pursuant to an amendment to such a statute
made on or after the date of enactment of the Food and
Drug Administration Modernization Act of 1997.
“(2) State initiatives.–This section shall not apply to a
State requirement adopted by a State public initiative or
referendum enacted prior to September 1, 1997.
“(e) No Effect on Product Liability Law.–Nothing in this section
shall be construed to modify or otherwise affect any action or the
liability of any person under the product liability law of any State.
“(f) State Enforcement Authority.–Nothing in this section shall
prevent a State or political subdivision thereof from enforcing, under
any relevant civil or other enforcement authority, a requirement that is
identical to a requirement of this Act.”.
(b) Inspections.–Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended
by striking “prescription drugs” each place it appears and inserting
“prescription drugs, nonprescription drugs intended for human use,”.
(c) Misbranding.–Subparagraph (1) of section 502(e) (21 U.S.C.
352(e)(1)) is amended to read as follows:
“(1)(A) If it is a drug, unless its label bears, to the exclusion
of any other nonproprietary name (except the applicable systematic
chemical name or the chemical formula)–
“(i) the established name (as defined in subparagraph (3))
of the drug, if there is such a name;
“(ii) the established name and quantity or, if determined
to be appropriate by the Secretary, the proportion of each
active ingredient, including the quantity, kind, and proportion
of any alcohol, and also including whether active or not the
established name and quantity or if determined to be appropriate
by the Secretary, the proportion of any bromides, ether,
chloroform, acetanilide, acetophenetidin, amidopyrine,
antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis,
digitalis glucosides, mercury, ouabain, strophanthin,
strychnine, thyroid, or any derivative or preparation of any
such substances, contained therein, except that the requirement
for stating the quantity of the active ingredients, other than
the quantity of those specifically named in this subclause,
shall not apply to nonprescription drugs not intended for human
use; and
“(iii) the established name of each inactive ingredient
listed in alphabetical order on the outside container of the
retail package and, if determined to be appropriate by the
Secretary, on the immediate container, as prescribed in
regulation promulgated by the Secretary, except that nothing in
this subclause shall be deemed to require that any trade secret
be divulged, and except that the requirements of this subclause
with respect to alphabetical order shall apply only to
nonprescription drugs that are not also cosmetics and that this
subclause shall not apply to nonprescription drugs not intended
for human use.
“(B) For any prescription drug the established name of such drug or
ingredient, as the case may be, on such label (and on any labeling on which a name for such drug or ingredient is used) shall
be printed prominently and in type at least half as large as that used
thereon for any proprietary name or designation for such drug or
ingredient, except that to the extent that compliance with the
requirements of subclause (ii) or (iii) of clause (A) or this clause is
impracticable, exemptions shall be established by regulations
promulgated by the Secretary.”.
(d) Cosmetics.–Subchapter F of chapter VII, as amended by
subsection (a), is further amended by adding at the end the following:
<> “SEC. 752. PREEMPTION FOR LABELING OR
PACKAGING OF COSMETICS.
“(a) In General.–Except as provided in subsection (b), (d), or
(e), no State or political subdivision of a State may establish or
continue in effect any requirement for labeling or packaging of a
cosmetic that is different from or in addition to, or that is otherwise
not identical with, a requirement specifically applicable to a
particular cosmetic or class of cosmetics under this Act, the Poison
Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair
Packaging and Labeling Act (15 U.S.C. 1451 et seq.).
“(b) Exemption.–Upon application of a State or political
subdivision thereof, the Secretary may by regulation, after notice and
opportunity for written and oral presentation of views, exempt from
subsection (a), under such conditions as may be prescribed in such
regulation, a State or political subdivision requirement for labeling or
packaging that–
“(1) protects an important public interest that would
otherwise be unprotected;
“(2) would not cause a cosmetic to be in violation of any
applicable requirement or prohibition under Federal law; and
“(3) would not unduly burden interstate commerce.
“(c) Scope.–For purposes of subsection (a), a reference to a State
requirement that relates to the packaging or labeling of a cosmetic
means any specific requirement relating to the same aspect of such
cosmetic as a requirement specifically applicable to that particular
cosmetic or class of cosmetics under this Act for packaging or labeling,
including any State requirement relating to public information or any
other form of public communication.
“(d) No Effect on Product Liability Law.–Nothing in this section
shall be construed to modify or otherwise affect any action or the
liability of any person under the product liability law of any State.
“(e) State Initiative.–This section shall not apply to a State
requirement adopted by a State public initiative or referendum enacted
prior to September 1, 1997.”.
SEC. 413. FOOD AND DRUG ADMINISTRATION STUDY OF MERCURY COMPOUNDS IN DRUGS AND
FOOD.
(a) List and Analysis.–The Secretary of Health and Human Services
shall, acting through the Food and Drug Administration–
(1) compile a list of drugs and foods that contain
intentionally introduced mercury compounds, and
(2) provide a quantitative and qualitative analysis of the
mercury compounds in the list under paragraph (1).
The Secretary shall compile the list required by paragraph (1) within 2
years after the date of enactment of the Food and Drug Administration
Modernization Act of 1997 and shall provide the analysis required by paragraph (2) within 2 years after such date of enactment.
(b) Study.–The Secretary of Health and Human Services, acting
through the Food and Drug Administration, shall conduct a study of the
effect on humans of the use of mercury compounds in nasal sprays. Such
study shall include data from other studies that have been made of such use.
(c) Study of Mercury Sales.–
(1) Study.–The Secretary of Health and Human Services,
acting through the Food and Drug Administration and subject to
appropriations, shall conduct, or shall contract with the
Institute of Medicine of the National Academy of Sciences to
conduct, a study of the effect on humans of the use of
elemental, organic, or inorganic mercury when offered for sale
as a drug or dietary supplement. Such study shall, among other things, evaluate–
(A) the scope of mercury use as a drug or dietary supplement; and
(B) the adverse effects on health of children and other sensitive populations resulting from exposure to,
or ingestion or inhalation of, mercury when so used.
In conducting such study, the Secretary shall consult with the
Administrator of the Environmental Protection Agency, the Chair
of the Consumer Product Safety Commission, and the Administrator
of the Agency for Toxic Substances and Disease Registry, and, to
the extent the Secretary believes necessary or appropriate, with
any other Federal or private entity.
(2) Regulations.–If, in the opinionOpinion A judge's written explanation of a decision of the court. In an appeal, multiple opinions may be written. The court’s ruling comes from a majority of judges and forms the majority opinion. A dissenting opinion disagrees with the majority because of the reasoning and/or the principles of law on which the decision is based. A concurring opinion agrees with the end result of the court but offers further comment possibly because they disagree with how the court reached its conclusion. of the Secretary, the
use of elemental, organic, or inorganic mercury offered for sale
as a drug or dietary supplement poses a threat to human health,
the Secretary shall promulgate regulations restricting the sale
of mercury intended for such use. At a minimum, such regulations
shall be designed to protect the health of children and other
sensitive populations from adverse effects resulting from
exposure to, or ingestion or inhalation of, mercury. Such
regulations, to the extent feasible, should not unnecessarily
interfere with the availability of mercury for use in religious ceremonies.
SEC. 414. INTERAGENCY COLLABORATION.
Section 903 (21 U.S.C. 393), as amended by section 406, is further amended by inserting after subsection (b) the following:
“(c) Interagency Collaboration.–The Secretary shall implement
programs and policies that will foster collaboration between the
Administration, the National Institutes of Health, and other science-
based Federal agencies, to enhance the scientific and technical
expertise available to the Secretary in the conduct of the duties of the
Secretary with respect to the development, clinical investigation,
evaluation, and postmarket monitoring of emerging medical therapies,
including complementary therapies, and advances in nutrition and food science.”.
SEC. 415. CONTRACTS FOR EXPERT REVIEW.
Chapter IX (21 U.S.C. 391 et seq.), as amended by section 214, is further amended by adding at the end the following:
“SEC. 907. CONTRACTS FOR EXPERT REVIEW.
“(a) In General.–
“(1) Authority.–The Secretary may enter into a contract
with any organization or any individual (who is not an employee
of the Department) with relevant expertise, to review and
evaluate, for the purpose of making recommendations to the
Secretary on, part or all of any application or submission
(including a petition, notification, and any other similar form
of request) made under this Act for the approval or
classification of an article or made under section 351(a) of the
Public Health Service Act (42 U.S.C. 262(a)) with respect to a
biological product. Any such contract shall be subject to the
requirements of section 708 relating to the confidentiality of
information.
“(2) Increased efficiency and expertise through
contracts.–The Secretary may use the authority granted in
paragraph (1) whenever the Secretary determines that use of a
contract described in paragraph (1) will improve the timeliness
of the review of an application or submission described in
paragraph (1), unless using such authority would reduce the
quality, or unduly increase the cost, of such review. The
Secretary may use such authority whenever the Secretary
determines that use of such a contract will improve the quality
of the review of an application or submission described in
paragraph (1), unless using such authority would unduly increase
the cost of such review. Such improvement in timeliness or
quality may include providing the Secretary increased scientific
or technical expertise that is necessary to review or evaluate
new therapies and technologies.
“(b) Review of Expert Review.–
“(1) In general.–Subject to paragraph (2), the official of
the Food and Drug Administration responsible for any matter for
which expert review is used pursuant to subsection (a) shall
review the recommendations of the organization or individual who
conducted the expert review and shall make a final decision
regarding the matter in a timely manner.
“(2) Limitation.–A final decision by the Secretary on any
such application or submission shall be made within the
applicable prescribed time period for review of the matter as
set forth in this Act or in the Public Health Service Act (42 U.S.C. 201 et seq.).”.
SEC. 416. PRODUCT CLASSIFICATION.
Subchapter E of chapter V, as amended by section 404, is further
amended by adding at the end the following:
“SEC. 563. CLASSIFICATION OF PRODUCTS.
“(a) Request.–A person who submits an application or submission
(including a petition, notification, and any other similar form of
request) under this Act for a product, may submit a request to the
Secretary respecting the classification of the product as a drug,
biological product, device, or a combination product subject to section
503(g) or respecting the component of the Food and Drug Administration
that will regulate the product. In submitting the request, the person
shall recommend a classification for the product, or a component to
regulate the product, as appropriate.
“(b) Statement.–Not later than 60 days after the receipt of the
request described in subsection (a), the Secretary shall determine the
classification of the product under subsection (a), or the component of
the Food and Drug Administration that will regulate the product, and
shall provide to the person a written statement that identifies such classification or such component, and the reasons for such determination. The Secretary may not modify such statement
except with the written consent of the person, or for public health reasons based on scientific evidence.
“(c) Inaction of Secretary.–If the Secretary does not provide the
statement within the 60-day period described in subsection (b), the
recommendation made by the person under subsection (a) shall be
considered to be a final determination by the Secretary of such
classification of the product, or the component of the Food and Drug
Administration that will regulate the product, as applicable, and may
not be modified by the Secretary except with the written consent of the
person, or for public health reasons based on scientific evidence.”.
SEC. 417. REGISTRATION OF FOREIGN ESTABLISHMENTS.
Section 510(i) (21 U.S.C. 360(i)) is amended to read as follows:
“(i)(1) Any establishment within any foreign country engaged in the
manufacture, preparation, propagation, compounding, or processing of a
drug or a device that is imported or offered for import into the United
States shall register with the Secretary the name and place of business
of the establishment and the name of the United States agentAgent An agent is a person employed to do any act for another or to represent another in dealings with third persons. The person for whom such act is done, or who is so represented, is called the principal. Indian Contract Act for the
establishment.
“(2) The establishment shall also provide the information required
by subsection (j).
“(3) The Secretary is authorized to enter into cooperative
arrangements with officials of foreign countries to ensure that adequate
and effective means are available for purposes of determining, from time
to time, whether drugs or devices manufactured, prepared, propagated,
compounded, or processed by an establishment described in paragraph (1),
if imported or offered for import into the United States, shall be
refused admission on any of the grounds set forth in section 801(a).”.
SEC. 418. CLARIFICATION OF SEIZURE AUTHORITY.
Section 304(d)(1) (21 U.S.C. 334(d)(1)) is amended–
(1) in the fifth sentence, by striking “paragraphs (1) and
(2) of section 801(e)” and inserting “subparagraphs (A) and
(B) of section 801(e)(1)”; and
(2) by inserting after the fifth sentence the following:
“Any person seeking to exportExport How to export: Canada-India-USA an imported article pursuant to
any of the provisions of this subsection shall establish that
the article was intended for export at the time the article
entered commerce.”.
SEC. 419. INTERSTATE COMMERCE.
Section 709 (21 U.S.C. 379a) is amended by striking “a device” and
inserting “a device, food, drug, or cosmetic”.
SEC. 420. SAFETY REPORT DISCLAIMERS.
Chapter VII (21 U.S.C. 371 et seq.), as amended by section 412, is
further amended by adding at the end the following:
“Subchapter G–Safety Reports
“SEC. 756. SAFETY REPORT DISCLAIMERS.
“With respect to any entity that submits or is required to submit a
safety report or other information in connection with the safety of a
product (including a product that is a food, drug, device, dietary supplement, or cosmetic) under this Act (and any release
by the Secretary of that report or information), such report or
information shall not be construed to reflect necessarily a conclusion
by the entity or the Secretary that the report or information
constitutes an admission that the product involved malfunctioned, caused
or contributed to an adverse experience, or otherwise caused or
contributed to a death, serious injury, or serious illness. Such an
entity need not admit, and may deny, that the report or information
submitted by the entity constitutes an admission that the product
involved malfunctioned, caused or contributed to an adverse experience,
or caused or contributed to a death, serious injury, or serious
illness.”.
SEC. 421. LABELING AND ADVERTISING REGARDING COMPLIANCE WITH
STATUTORY REQUIREMENTS.
Section 301 (21 U.S.C. 331) is amended by striking paragraph (l).
<> SEC. 422. RULE OF CONSTRUCTION.
Nothing in this Act or the amendments made by this Act shall be
construed to affect the question of whether the Secretary of Health and
Human Services has any authority to regulate any tobacco product,
tobacco ingredient, or tobacco additive. Such authority, if any, shall
be exercised under the Federal Food, Drug, and Cosmetic Act as in effect
on the day before the date of the enactment of this Act.
TITLE V–EFFECTIVE DATE
SEC. 501. EFFECTIVE DATE.
Except as otherwise provided in this Act, this Act and the amendments made by this Act, other than the provisions of and the amendments made by sections 111, 121, 125, and 307, shall take effect 90
days after the date of enactment of this Act.
Approved November 21, 1997.
LEGISLATIVE HISTORY–S. 830 (H.R. 1411):
HOUSE REPORTS: Nos. 105-310, accompanying H.R. 1411 (Comm. on Commerce)
and 105-399 (Comm. of Conference).
SENATE REPORTS: No. 105-43 (Comm. on Labor and Human Resources).
CONGRESSIONAL RECORD, Vol. 143 (1997):
Sept. 11, 16, 18, 19, 23, 24, considered and passed Senate.
Oct. 7, considered and passed House, amended, in lieu of
H.R. 1411.
Nov. 9, Senate and House agreed to conference report.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 33 (1997):
Nov. 21, Presidential remarks.
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