Food and Drug Administration (U.S.)

Food and Drug Administration

Food and Drug Administration (FDA), agency of the Public Health Service division of the U.S. Department of Health and Human Services. It is charged with protecting public health by ensuring that foods are safe and pure, cosmetics and other chemical substances harmless, and products safe, effective, and honestly labeled. The Food, Drug, and Cosmetic Act of 1938 and various bills since have strengthened government control by requiring prior-evidence-of-safety tests and procedures for new drugs, pesticides, and additives and colorings in foods and cosmetics. The FDA was first established in 1931; in 1940 it was transferred from the Dept. of Agriculture to the Federal Security Agency and in 1953 to the Dept. of Health, Education and Welfare, which was redesignated as Health and Human Services in 1979. The FDA consists of the centers for Drug Evaluation and Research, Biologics Evaluation and Research, Food Safety and Applied Nutrition, Veterinary Medicine, Devices and Radiological Health, and Toxicological Research. In the early 1990s, in response to criticism that its time-consuming approval processes penalized people with AIDS, it extended the classification system it uses to prioritize drugs in order to give AIDS drugs the highest priority; it also subsequently sped up the approval process for cancer drugs. Congressional legislation in 1997 mandated an overhaul of the FDA in order to speed review of new drugs and medical devices.

See P. J. Hilt, Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation (2003) and D. Carpenter, Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (2010).

The Columbia Encyclopedia, 6th ed. Copyright© 2014, The Columbia University Press.

Selected full-text books and articles on this topic

Pill Politics: Drugs and the FDA
Stephen J. Ceccoli.
Lynne Rienner, 2004
Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA
Daniel Carpenter.
Princeton University Press, 2010
The New Medicines: How Drugs Are Created, Approved, Marketed, and Sold
Bernice Schacter.
Praeger, 2006
Librarian’s tip: Chap. 2 "How Did the FDA Get to Be in Charge? The History of Regulation of Human Drugs," Chap. 13 "Everybody Holds Their Breath: Will the FDA File the NDA?," and Chap. 14 "The FDA Review"
New Drug Research, the Extraterritorial Application of FDA Regulations, and the Need for International Cooperation
DuBois, William.
Vanderbilt Journal of Transnational Law, Vol. 36, No. 1, January 2003
Federal Food and Drug Act Violations
Baer, Megan Hanley; Moore, Whitney.
American Criminal Law Review, Vol. 40, No. 2, Spring 2003
Military Use of Drugs Not Yet Approved by the FDA for CW/BW Defense: Lessons from the Gulf War
Richard A. Rettig.
Rand, 1999
Peddling Poison: The Tobacco Industry and Kids
Clete Snell.
Praeger, 2005
Librarian’s tip: Chap. 3 "The FDA Investigation of Big Tobacco"
Regulatory Encounters: Multinational Corporations and American Adversarial Legalism
Robert A. Kagan; Lee Axelrad.
University of California Press, 2000
Librarian’s tip: Chap. Ten "Licensing Biologics in Europe and the United States"
Sometimes the Silence Can Be like the Thunder: Access to Pharmaceutical Data at the FDA
Lurie, Peter; Zieve, Allison.
Law and Contemporary Problems, Vol. 69, No. 3, Summer 2006
Human Cloning and the FDA. (at Law)
Dresser, Rebecca.
The Hastings Center Report, Vol. 33, No. 3, May-June 2003
A Historical Guide to the U. S. Government
George Thomas Kurian.
Oxford University Press, 1998
Librarian’s tip: "Food and Drug Administration" begins on p. 248
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