The United States Food and Drug Administration is the government agency responsible for regulating food, dietary supplements, drugs, cosmetics, medical devices, biologics and blood products in the United States. The agency is authorized by the government to inspect, test, approve, and set safety standards for foods, chemicals, medical devices, cosmetics, and household devices (britanica.org). Made up of 2,100 scientist including chemists, pharmacologists, physicians, microbiologists, pharmacists, and lawyers, the FDA oversees the production of safe foods and the manufacturing of safe and effective drugs and is responsible in protecting the rights and safety of patients who are used in clinical trials for medical products. (allgov.com). They
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It was first called The Division of Chemistry, then changed to The Bureau of Chemistry then renamed to The Food, Drug, and Insecticide Administration, and then finally changed to what it is called today, The United States Food and Administration. The FDA is the oldest consumer protection agency in the United States Federal Government. At first the agency focused on the regulation of food, but over the years it has changed its focus to the regulation of drugs, with some emphasis on patent medicines (allgov.com). The FDA’s regulatory functions began with the passage of the 1906 Pure Food and Drugs …show more content…
By 1962, the drug had been sold in 46 countries and it became clear that the pill was damaging the fetus and was causing birth defects such as still birth and phocomelia. This pill ended up affecting thousands of babies in Europe. In the United States, a NDA for the pill was submitted in 1960 but was delayed due to the FDA investigating another issue somewhere else. The FDA did not even suspect that the pill was causing birth defects. The FDA’s delay on the NDA of this pill saved many lives in the U.S., because officials then saw what was happening in Europe and did everything they could to ban the drug from the American market. President Kennedy then gave “The Distinguished Federal Civil Service Award” to the FDA physician who delayed the NDA approval on this drug. The FDA then created the Kefauver-Harris Amendments in response to this situation. According to these amendments, drug manufacturers were required to prove the effectiveness of drugs before they started marketing campaigns. It authorized the FDA to require companies to conduct tests determining safety and efficacy. This increased the FDA’s regulatory power over manufacturing and also increased the FDA staff from one thousand members to sixty-five hundred members over 10 years
It was first called The Division of Chemistry, then changed to The Bureau of Chemistry then renamed to The Food, Drug, and Insecticide Administration, and then finally changed to what it is called today, The United States Food and Administration. The FDA is the oldest consumer protection agency in the United States Federal Government. At first the agency focused on the regulation of food, but over the years it has changed its focus to the regulation of drugs, with some emphasis on patent medicines (allgov.com). The FDA’s regulatory functions began with the passage of the 1906 Pure Food and Drugs …show more content…
By 1962, the drug had been sold in 46 countries and it became clear that the pill was damaging the fetus and was causing birth defects such as still birth and phocomelia. This pill ended up affecting thousands of babies in Europe. In the United States, a NDA for the pill was submitted in 1960 but was delayed due to the FDA investigating another issue somewhere else. The FDA did not even suspect that the pill was causing birth defects. The FDA’s delay on the NDA of this pill saved many lives in the U.S., because officials then saw what was happening in Europe and did everything they could to ban the drug from the American market. President Kennedy then gave “The Distinguished Federal Civil Service Award” to the FDA physician who delayed the NDA approval on this drug. The FDA then created the Kefauver-Harris Amendments in response to this situation. According to these amendments, drug manufacturers were required to prove the effectiveness of drugs before they started marketing campaigns. It authorized the FDA to require companies to conduct tests determining safety and efficacy. This increased the FDA’s regulatory power over manufacturing and also increased the FDA staff from one thousand members to sixty-five hundred members over 10 years