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The United States Food and Drug Administration is the government agency responsible for regulating food, dietary supplements, drugs, cosmetics, medical devices, biologic s and blood products in the United States.One aspect of its jurisdiction over food is regulation of the content of health claims on food labels.
One of the key issues of drug safety dealt with the FDA, and responsible for much recent controversy, is related to the concept of patents. The patenting of a drug gives the creator exclusive right to manufacture those drugs, and if the drug is extremely popular, this motivates other companies to try to invent drugs of their own that are different but accomplish the same effect (because they can't produce the exact same drug in order to compete because it's patented). For example, Cialis was created because of the popularity of Viagra. When new, competing substances come out however, the question is should they be approved, not because of their absolute safety, but because of their relative safety compared to a drug that's already out that does the same thing. For example, say "drug b" was created to compete with "drug a". Now if "drug b" was the first one out, and it had a 5 percent chance of heart attack, the FDA might find this acceptable. However if "drug a" was already out, and it had a 2.5 percent chance of heart attack, then the FDA would be reluctant to approve "b" because the only people who would seemingly take drug b would either be ignorant of that higher risk or might buy it because its cheaper, which creates an unhealthy conflict of interest between profit and health. This phenonemon is at the center of a present controversy over the recall of Vioxx, which is causing more attention to be brought to the FDA.
David J. Graham, a scientist with the FDA, says he was pressured by his supervisors not to warn the public about dangers of drugs like Vioxx, and so recommended to congress that a separate agency be created which is dedicated to continously monitoring drug safety.
1 History
- 1927 The "Bureau of Chemistry" is reorganized into two separate entities. Regulatory functions are located in the "Food, Drug, and Insecticide Administration", and nonregulatory research is located in the "Bureau of Chemistry and Soils".
- 1930 The name of the "Food, Drug, and Insecticide Administration" is shortened to "Food and Drug Administration" (FDA) under an agricultural appropriations act.
The FDA does not protect consumers as much as many people might think. See Leavitt, Fred (2003) The REAL Drug Abusers. Rowman & Littlefield.
2 Related Legislation
- 1951 Food, Drug, and Cosmetics Act Amendments PL 82215
- 1953 Flammable Fabrics Act PL 8388
- 1960 Federal Hazardous Substances Labeling Act PL 86613
- 1962 Food, Drug, and Cosmetics Act Amendments PL 87781
- 1965 Federal Cigarette Labeling and Advertising Act PL 8992
- 1966Events January January 1 In a coup, Colonel Jean-Bedel Bokassa ousts president David Dacko and takes over the Central African Republic. January 2 Strike of public transportation workers in New York City ends January 13 January 3 First Acid Test at the Fil Fair Packaging and Labeling Act PL 89755
- 1966Events January January 1 In a coup, Colonel Jean-Bedel Bokassa ousts president David Dacko and takes over the Central African Republic. January 2 Strike of public transportation workers in New York City ends January 13 January 3 First Acid Test at the Fil Child Protection Act PL 89756
- 1970Events January events January 1 Construction begins on Arcosanti, by Paolo Soleri, in Mayer, Arizona, located 65, miles north of Phoenix, Arizona. January 1 Unix epoch at 00:00:00 UTC. January 12 Biafra capitulates, ending the Nigerian civil war. January Federal Cigarette Labeling and Advertising Act Amendments PL 91222
- 19721972 is a leap year starting on Saturday (click link for calendar). Events January events January 2 the Pierre Hotel Heist Six men rob the safety deposit boxes of the Pierre Hotel in New York City. Loot is at least $4 million January 5 President of the Un Consumer Products Safety Act PL 92573
- 19761976 is a leap year starting on Thursday (link will take you to calendar). Events January January 12 UN Security Council votes 11-1 to admit the Palestinian Liberation Organization January 15 Would-be Gerald Ford presidential assassin Sara Jane Moore is s Medical Device Regulation Act PL 94295
- 19861986 is a common year starting on Wednesday. Events January January 1 Spain and Portugal enter the European Community January 1 Aruba gains increased autonomy from the Netherlands and is separated from the Netherlands Antilles. January 9 After losing a pa Comprehensive Smokeless Tobacco Health Education Act PL 99252
- 19881988 is a leap year starting on Friday (click on link for calendar). Events January January 2 Georgia celebrates its bicentennial statehood. January 9 Connecticut celebrates its bicentennial statehood. January 26 Australia celebrates its bicentennial day. Antidrug Abuse Act PL 100690
- 1990Events January January 3 Former leader of Panama Manuel Noriega surrenders to American forces. January 7 The Leaning Tower of Pisa is closed to the public due to safety concerns. January 9 Lt Gen Bazilio Olara Okello The man who led the coup aginst Dr Apo Nutrition Labeling and Education Act PL 101535
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