The F.D.A.

Prashant Bhatt

In a country one needs to maintain a standard for the products an average human consumes. A certain limits to the constituents and a regulation body. In the US. there is such a body that is called as the FDA or the Food and Drug Administration. It is a regulatory body for the food and drug market in the country it also controls fields of medical devices, radiation emitting devices, veterinarian medication, cosmetics, and tobacco products.

This department is a federal agency of the United States Department of Health and Human Services, and was established in June 30, 1906. This body is governed by a commissioner of food and drugs that has been appointed by the president himself/herself. Scott Gottlieb is the current commissioner. This department has its headquarters in White Oak, Maryland. The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico. In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.

This department not only regulates the drugs and other medicinal products but also regulates their advertising in the regular media. It also regulates scams related to the drugs for example the generic drug scam where a major scandal erupted in 1989 involving the procedures used by the FDA to approve generic drugs for sale to the public. Charges of corruption in generic drug approval first emerged in 1988, in the course of an extensive congressional investigation into the FDA. The oversight sub-commitee of the United States House Energy and Commerce Committee resulted from a complaint brought against the FDA by Mylan Laboratories Inc. of Pittsburgh. When its application to manufacture generics were subjected to repeated delays by the FDA, Mylan, convinced that it was being discriminated against, soon began its own private investigation of the agency in 1987. Mylan eventually filed suit against two former FDA employees and four drug-manufacturing companies, charging that corruption within the federal agency resulted in racketeering and in violations of antitrust law. "The order in which new generic drugs were approved was set by the FDA employees even before drug manufacturers submitted applications" and, according to Mylan, this illegal procedure was followed to give preferential treatment to certain companies. During the summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancato, Walter Kletch) pleaded guilty to criminal charges of accepting bribes from generic drugs makers, and two companies (Par Pharmaceutical and its subsidiary Quad Pharmaceuticals)[39] pleaded guilty to giving bribes.

Also in the country there is a difference in FDA cleared and the FDA approved ie. If a product is cleared at a point of time it can’t be trusted whereas an approved product can be used as a standard.


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