The Food and Drug Administration touches the lives of virtually every American every day. The Food and Drug Administration Modernization Act, enacted Nov. 21, 1997, amended the Federal Food, Drug, and Cosmetic Act relating to the regulation of food, drugs, devices, and biological products. With the passage of FDAMA, Congress enhanced FDA’s mission in ways that recognized the Agency would be operating in a 21st century characterized by increasing technological, trade and public health complexities. For it is FDA’s job to see that the food we eat is safe and wholesome, the cosmetics we use won’t hurt us, the medicines and medical devices we use are safe and effective, and that radiation-emitting products such as microwave ovens won’t do us harm. Feed and drugs for pets and farm animals also come under FDA scrutiny. FDA also ensures that all of these products are labeled truthfully with the information that people need to use them properly.
FDA is one of our nation’s oldest consumer protection agencies. The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, expands the FDA’s authorities and strengthens the agency’s ability to safeguard and advance public health. FDASIA gave FDA a new and powerful expedited drug development tool, known as the “breakthrough therapy” designation.
First and foremost, FDA is a public health agency, charged with protecting American consumers by enforcing the Federal Food, Drug, and Cosmetic Act and several related public health laws. To carry out this mandate of consumer protection, FDA has more than 1,100 investigators and inspectors who cover the country’s almost 195,000 FDA-regulated businesses. These employees are located in district and local offices in cities across the country. With nearly 40 percent of finished drugs being imported, and nearly 80 percent of active ingredients coming from overseas sources, protecting the global drug supply chain and making sure that patients have access to the drugs they need is a priority for FDA.
Inspections and Legal Sanctions
These investigators and inspectors visit more than 5,0000 facilities a year, seeing that products are made right and labeled truthfully. As part of their inspections, they collect about 180,000 domestic and imported product samples for examination by FDA scientists or for label checks.
If a company is found violating any of the laws that FDA enforces, FDA can encourage the firm to voluntarily correct the problem or to recall a faulty product from the market. A recall is generally the fastest and most effective way to protect the public from an unsafe product.
When a company can’t or won’t correct a public health problem with one of its products voluntarily, FDA has legal sanctions it can bring to bear. The agency can go to court to force a company to stop selling a product and to have items already produced seized and destroyed. When warranted, criminal penalties–including prison sentences–are sought against manufacturers and distributors.
About 13,000 products a year are found to be unfit for consumers and are withdrawn from the marketplace, either by voluntary recall or by court-ordered seizure. In addition, about 50,000 import shipments a year are detained at the port of entry because the goods appear to be unacceptable.
The scientific evidence needed to back up FDA’s legal cases is prepared by the agency’s scientists, including chemists and microbiologists, who work in multiple laboratories in the Washington, D.C., area and around the country. Some of these scientists analyze samples to see, for example, if products are contaminated with illegal substances. Other scientists review test results submitted by companies seeking agency approval for drugs, vaccines, food additives, coloring agents and medical devices.
FDA also operates the National Center for Toxicological Research at Jefferson, Arkansas, which investigates the biological effects of widely used chemicals. The agency also runs the Engineering and Analytical Center at Winchester, Massachusetts, which tests medical devices, radiation-emitting products, and radioactive drugs.
Assessing risks–and, for drugs and medical devices, weighing risks against benefits–is at the core of FDA’s public health protection duties. By ensuring that products and producers meet certain standards, FDA protects consumers and enables them to know what they’re buying. For example, the agency requires that drugs–both prescription and over-the-counter–be proven safe and effective.
In deciding whether to approve new drugs, FDA does not itself do research, but rather examines the results of studies done by the manufacturer. The agency must determine that the new drug produces the benefits it’s supposed to without causing side effects that would outweigh those benefits.
Another major FDA mission is to protect the safety and wholesomeness of food. The agency’s scientists test samples to see if any substances, such as pesticide residues, are present in unacceptable amounts. If contaminants are identified, FDA takes corrective action. FDA also sets labeling standards to help consumers know what is in the foods they buy.
The nation’s food supply is protected in yet another way as FDA sees that medicated feeds and other drugs given to animals raised for food are not threatening to the consumer’s health.
The safety of the nation’s blood supply is another FDA responsibility. The agency’s investigators routinely examine blood bank operations, from record-keeping to testing for contaminants. FDA also ensures the purity and effectiveness of biologicals (medical preparations made from living organisms and their products), such as insulin and vaccines.
Medical devices are classified and regulated according to their degree of risk to the public. Devices that are life-supporting, life-sustaining or implanted, such as pacemakers, must receive agency approval before they can be marketed.
FDA’s scrutiny does not end when a drug or device is approved for marketing; the agency collects and analyzes tens of thousands of reports each year on drugs and devices after they have been put on the market to monitor for any unexpected adverse reactions.
Cosmetic safety also comes under FDA’s jurisdiction. The agency can have unsafe cosmetics removed from the market. The dyes and other additives used in drugs, foods and cosmetics also are subject to FDA scrutiny. The agency must review and approve these chemicals before they can be used.
FDA is an agency within the Department of Health and Human Services.
Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144)
18 sections of Title VII are summarized below.
Sec. 701-702, Registration of Domestic and Foreign Drug Establishments
Sec. 703, Identification of Drug Excipient Information with Product Listing
Sec. 704, Electronic System for Registration and Listing
Sec. 705, Risk-based Inspection Frequency
Sec. 706, Records for Inspection
Sec. 707, Prohibition Against Delaying, Denying, Limiting or Refusing Inspection
Sec. 708, Destruction of Adulterated, Misbranded or Counterfeit Drugs Offered for Import
Sec. 709, Administrative Detention
Sec. 710, Exchange of Information
Sec. 711, Enhancing the Safety and Quality of the Drug Supply
Sec. 712, Recognition of Foreign Government Inspections
Sec. 713, Standards for Admission of Imported Drugs
Sec. 714, Registration of Commercial Importers
Sec. 715, Notification
Sec. 716, Protection against Intentional Adulteration
Sec. 717, Penalties for Counterfeiting Drugs
Sec. 718, Extraterritorial Jurisdiction