How the FDA grew from one chemist to today

The U.S. Food and Drug Administration began as a single chemist in the U.S. Department of Agriculture in 1862. It is a scientific, regulatory, and public health agency whose jurisdiction covers most foods except meat and poultry, drugs for people and animals, biological therapeutic agents, medical devices, radiation-emitting products, cosmetics, and animal feed. According to an FDA History Office account, those items account for 20 cents of every dollar spent by consumers.

From one chemist to a bureau

President Lincoln appoints chemist Charles M. Wetherill to serve in the Department of Agriculture in 1862. The FDA says that appointment started the Bureau of Chemistry, later the predecessor of the Food and Drug Administration. The office begins as the Division of Chemistry and, after July 1901, becomes the Bureau of Chemistry.

Federal drug controls are older than that office. The first federal biologics law, aimed at reliable smallpox vaccine, passes in 1813. In 1848, the Drug Importation Act orders the U.S. Customs Service to inspect shipments so adulterated drugs do not enter from abroad.

Dr. Harvey W. Wiley becomes chief chemist in 1883 and expands the bureau’s food adulteration studies. The FDA record calls him the “Crusading Chemist” and “Father of the Pure Food and Drugs Act.” He retires from government service in 1912.

The 1906 statute and a regulatory mission

The modern era of the FDA dates to 1906 and the Federal Food and Drugs Act, according to the FDA History Office. Congress passes the original Food and Drugs Act on June 30, 1906, and President Theodore Roosevelt signs it. The law prohibits interstate commerce in misbranded and adulterated foods, drinks, and drugs, and the Bureau of Chemistry enforces it.

There is no requirement that information be submitted before marketing. The law requires only that drugs match standards for strength and purity. The government bears the burden of showing that a drug’s labeling is false and misleading before the drug can be taken off the market.

In U.S. v. Johnson in 1911, the Supreme Court rules that the 1906 act does not prohibit false therapeutic claims, only false and misleading statements about ingredients or identity. In 1912, the Sherley Amendment prohibits labeling medicines with false therapeutic claims intended to defraud the purchaser.

In July 1927, regulatory functions move to the Food, Drug, and Insecticide Administration, and nonregulatory research goes elsewhere in the department. In July 1930, the name is shortened to Food and Drug Administration under an agricultural appropriations act.

Safety before marketing

In 1937, a product called Elixir of Sulfanilamide, made with the toxic solvent diethylene glycol, causes the deaths of 107 people, many of them children. Congress passes the Federal Food, Drug, and Cosmetic Act, and President Franklin Roosevelt signs it on June 25, 1938. For the first time, manufacturers must show that a drug is safe before it can be marketed.

The 1938 act also extends control to cosmetics and therapeutic devices. It drops the Sherley Amendment’s demand that prosecutors show a purpose to defraud in cases of misbranded drugs. It authorizes factory inspections, food standards, and safe tolerances for unavoidable poisonous substances.

The FDA transfers from the Department of Agriculture to the Federal Security Agency in June 1940, and Walter G. Campbell is appointed the first Commissioner of Food and Drugs. In April 1953, the agency moves to the Department of Health, Education, and Welfare. A 1968 reorganization places it in the Public Health Service, and in May 1980 that department becomes the Department of Health and Human Services.

Effectiveness, devices, and user fees

In October 1962, Congress passes the Kefauver-Harris Drug Amendments. Manufacturers must prove to the FDA the effectiveness of their products before marketing them. The amendments also require the FDA to approve the marketing application before a drug can be marketed, and they move oversight of ads for prescription drugs from the Federal Trade Commission to the FDA.

The Medical Device Amendments of 1976 require manufacturers to register with the FDA and follow quality control procedures. Some products must have pre-market approval, and others must meet performance standards before marketing. The Orphan Drug Act of 1983 enables the FDA to encourage study and sale of medicines used to treat uncommon illnesses.

The Drug Price Competition and Patent Term Restoration Act of 1984 permits the FDA to approve generic copies of brand-name drugs without redoing the studies that showed the originals were safe and worked. The Prescription Drug User Fee Act of 1992 requires drug and biologics manufacturers to pay fees for product applications, supplements, and other services, and requires the FDA to use those funds to hire more reviewers. The Food and Drug Administration Modernization Act of 1997 reauthorizes that fee law.

The Food and Drug Administration Act of 1988 officially establishes the FDA as an agency of the Department of Health and Human Services. A Commissioner of Food and Drugs is appointed by the President with the advice and consent of the Senate.

Safety reports and the scale of the work

In 1993, the FDA launches MedWatch for voluntary reporting of problems associated with medical products. In 2005, the FDA forms the Drug Safety Oversight Board to advise the Center for Drug Evaluation and Research. Board members include FDA staff and representatives from the National Institutes of Health and the Veterans Administration.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 follows the events of Sept. 11, 2001. Among its provisions is a requirement that the FDA write rules to tighten oversight of imported and U.S.-made goods the agency regulates. The Project BioShield Act of 2004 authorizes the FDA to speed up review procedures so treatments can be distributed rapidly as countermeasures to chemical, biological, and nuclear agents.

According to the FDA History Office, the agency employs roughly 15,000 people in 2014 and has a budget of $4.4 billion. That account says the FDA watches how about $1 trillion worth of products are made, brought in, moved, stored, and sold each year, and that investigators and inspectors visit more than 16,000 facilities a year. About one-third of employees are stationed outside the Washington, D.C., area, staffing over 150 field offices and laboratories.