The Food and Drug Administration (FDA) is an agency that falls under the umbrella of the U.S. Department of Health and Human Services.
It was officially formed in 1906, at the same time as the passage of the Pure Food and Drugs Act, an act whose goal was to prevent longstanding and serious abuses of consumer products—both food and drugs.
Appointed by the President, Dr. Margaret A. Hamburg is the FDA commissioner of food and drugs, and has run the agency since 2009.
The FDA is headquartered in Silver Spring, Md., but has 223 field offices and 13 laboratories around the country. In 2008 the FDA also began opening offices in foreign countries including China and India.
The primary mission of these foreign FDA posts is to help obtain information that will help FDA centers and border officials make better-informed decisions about the admission of foreign products into the U.S.
The FDA consists of six product centers, one research center, and two offices, several of which pertain to the drug industry:
• Center for Biologics Evaluation and Research, which regulates products such as vaccines, blood, and gene therapy.
• Center for Devices and Radiological Health, which regulates medical devices ranging from thermometers to kidney dialysis machines, and electronic products that give off radiation, such as microwave ovens.
• Center for Drug Evaluation and Research, which regulates over-the-counter and prescription medications.
• Center for Food Safety and Applied Nutrition, which regulates most foods, dietary supplements, and cosmetics.
• Center for Tobacco Products.
• Center for Veterinary Medicine.
• National Center for Toxicological Research.
• Office of Regulatory Affairs, which conducts inspections and enforces FDA regulations.
• Office of the Commissioner, which provides leadership and direction to FDA’s product centers, research center, and Office of Regulatory Affairs.
In terms of drugs, the FDA is responsible for protecting the health of the American public, by ensuring that drugs, vaccines, biological products and medical devices are safe, effective and properly labeled. It also aims to advance public health by helping to speed product innovations; and help the public get the information they need about medicines.
Of interest to pharmacists, the FDA regulates:
• dietary supplements
• human drugs
• vaccines, blood products, and other biologics
• medical devices, from items like tongue depressors, to complex technologies such as heart pacemakers
• electronic products that give off radiation, such as X-ray equipment cosmetics
The FDA approves every drug (branded, generic and over-the-counter) that is sold in the United States. It also has the authority to recall drugs or remove them from the market.
The FDA removes approved drugs from the market when it has discovered that the drug’s risks outweigh its benefits. But since completely removing a unique product from the market could be very dangerous to people who depend on the drug, these decisions are made very carefully, especially if people would be in danger without the product.
In the past 10 years only about a dozen drugs have been removed from the market.Manufacturers usually voluntarily stop marketing products at FDA’s request. But if the manufacturer disagrees with FDA’s decision, then FDA can take legal action to remove the unsafe drug from the marketplace and withdraw approval.
Usually any issues cause only minor concern and the FDA ensures that information and warnings are added to the label of the product to inform the public.