FDA
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U.S. Food and Drug Administration(FDA)
The United States Food and Drug Administration (FDA) falls within the executive branch of the US government, under the Department of Health and Human Services (DHHS). FDA is headed by the Commissioner of Food and Drugs, who is appointed by the President of the United States, confirmed by the US Senate, and serves at the President’s discretion. The Office of the Commissioner (OC) oversees all the Agency’s components and is responsible for the efficient and effective implementation of FDA’s mission.
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, United States food supply, cosmetics, and products that emit radiation.
The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
The United States Food and Drug Administration (FDA) headquarters is located at: 5600 Fishers Lane, Rockville MD 20857 1-888-INFO-FDA (1-888-463-6332)
FDA history
1800s
Federal controls over the US drug supply began in 1848 with the Drug Importation Act, which required US Customs to stop the importation of adulterated drugs. Due to the growing necessity for safe food and drug products, in 1862 President Abraham Lincoln appointed chemist Charles M. Wetherill to head the chemical division in the newly created Department of Agriculture. This division conducted numerous food adulteration studies. Late in the 1800s, more than 100 food and drug bills were introduced in Congress.
Early 1900s
In 1902, the Biologics Control Act was passed to ensure purity and safety of serums, vaccines, and similar products used to prevent or treat diseases in humans. Shocking disclosures of insanitary conditions in meatpacking plants, the use of poisonous preservatives and dyes in foods, and cure-all claims for worthless and dangerous patent medicines prompted Congress to pass the Food and Drugs Act in 1906. This federal law prohibited interstate commerce in misbranded and adulterated foods, drinks, and drugs. In 1930, what had become the Food, Drug, and Insecticide Administration was renamed the Food and Drug Administration (FDA).
1938
FDA was involved in a five-year legislative struggle to completely revise the Food and Drugs Act. Following the death of 107 persons, mostly children, who took a poisonous Elixir of Sulfanilamide, Congress greatly strengthened the public health protection by passing the Federal Food, Drug, and Cosmetic Act (FD&C Act). This new Act: extended FDA’s control to cosmetics and therapeutic devices; required new drugs to be proven safe before marketing; authorized standards of identity, quality, and fill-of-container for foods; authorized factory inspections; and increased the legal tools available to enforce provisions of the Act.
Mid 1900s
After the passage of the FD&C Act, numerous amendments, standards, and laws were passed, and court cases set precedents to further define FDA’s role in protecting the public health. These covered areas such as food sanitation standards, prosecution for violations, drug labeling and effectiveness, pesticide residues, biologics, food additives, packaging and labeling, low-acid canned foods, medical devices, infant formula, nutrition labeling, and dietary supplements. In 1949, FDA published its first guidance to industry.
1997
The Food and Drug Administration Modernization Act (FDAMA) mandated the most wide-ranging reforms in Agency practices since 1938. In FDAMA, Congress recognized that the protection of public health is a responsibility shared by the entire health care community. The law directs the Agency to carry out its mission in consultation and cooperation with all FDA stakeholders, including consumer and patient groups, the regulated industry, healthcare professionals, and FDA’s regulatory counterparts abroad. Provisions of FDAMA include measures to accelerate review of devices, regulate advertising of unapproved uses of approved drugs and devices, and regulate health claims for foods.
FDA today
With a more than 80% favorable rating in public opinion polls, the Agency is cooperating with its stakeholders in the US and abroad to continue protecting consumers and the public health in the new era of technological and scientific advances.
In the wake of the terrorist attacks on September 11, 2001, FDA has also been entrusted with two critical functions in the nation’s war on terrorism:
to prevent the willful contamination of all regulated products, including food.
to improve the availability of medications to prevent or treat injuries caused by biological, chemical, or nuclear agents.
Past FDA Commissioners
Mark B. McClellan (11/14/2002 - 3/26/2004)
Jane E. Henney (1/17/99 - 1/19/2001)
David A. Kessler (11/8/1990 - 2/28/1997)
Frank E. Young (07/15/1984 - 12/17/1989)
Arthur Hull Hayes Jr (4/13/1981 - 9/11/1983)
Jere E. Goyan (10/21/1979 - 1/20/1981)
Donald Kennedy (4/4/1977 - 6/30/1979)
Alexander M. Schmidt (7/20/1973 - 11/30/1976)
Charles Edwards (12/13/1969 - 3/15/1973)
Herbert Ley Jr (7/1/1968 - 12/12/1969)
James L. Goddard (1/17/1966 - 7/1/1968)
George P. Larrick (8/12/1954 - 12/27/1965)
Charles Crawford (6/1/1951 - 7/31/1954)
Paul B. Dunbar (5/6/1944 - 5/31/1951)
Walter G. Campbell (7/16/1921 - 6/30/1924; 7/1/1927 - 4/30/1944)
Carl L. Alsberg (12/16/1912 - 7/15/1921)
Harvey Washington Wiley (1/1/1907 - 3/15/1912)
Laws enforced by the FDA and related statutes
Federal Food, Drug, and Cosmetic Act
Additional Laws:
Animal Drug User Fee Act of 2003
Best Pharmaceuticals for Children Act
Congressional Reports Elimination Act of 1982
Controlled Substances Import and Export Act
Delegations of Authority to the Commissioner of Food and Drugs
Department of Education Organization Act
Dietary Supplement Health and Education Act of 1994
Fair Packaging and Labeling Act
Federal Advisory Committee Act
Federal Advisory Committee Amendments
Federal Food and Drugs Act of 1906
Federal Fines and Sentencing Laws
Federal Trade Commission Act
Filled Milk Act
Food Quality Protection Act of 1996
Foods and Drugs
GATT Uruguay Round Patent Provisions
Generic Animal Drug and Patent Term Restoration Act of 1988 (Summary)
Government in the Sunshine Act
Laws Delegating Authority -- Patents
Lead Based Paint Poisoning Prevention Act
Mammography Quality Standards Act (MQSA)
Medical Device User Fee and Modernization Act (MDUFMA) of 2002
Miscellaneous Provisions Relating to Orphan Drugs
The National Environmental Policy Act of 1969
Pediatric Research Equity Act of 2003
Poultry Products Inspection Act
Prescription Drug User Fee Act
Project BioShield Act of 2004
Public Health Service Act
Reorganization Plan 1 of 1953
Sanitary Food Transportation Act
Sentencing Guidelines
Tea Importation Act The Tea Importation Act was repealed in 1996 by Public Law 104-128
Trademark Act of 1946
Additional Enforcement Laws
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