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Glossary

Saturday, September 17, 2011

Food and Drug Administration (FDA)

 

The Food and Drug Administration (FDA or USFDA) is a US regulatory agency that is supposed to protect and promote public health. It has as its purview food, tobacco, drugs, vaccines, cosmetics, etc. The FDA is led by the Commissioner of Food and Drugs, which today is Dr. Margaret A. Hamburg who has served as Commissioner since February 2009.

The agency is headquartered in Maryland with field offices and laboratories throughout the US. FDA, surprisingly, has started opening offices in foreign countries, including China, India, Costa Rica, Chile, Belgium and the United Kingdom.

The Office of Regulatory Affairs of the FDA is the agency's main workhorse. Its investigators are inspectors that investigate complaints, illnesses and outbreaks and review necessary documentation. The Office of Regulatory Affairs has five regions divided into 13 districts

There is also an Office of Criminal Investigations started in 1991. OCI Special Agents are armed and can pursue actions the FDA considers to be criminal, such as fraudulent claims or shipping questionable products interstate.

The FDA works with numerous other agencies including the Department of Agriculture, Drug Enforcement Administration, Customs and Border Protection and Consumer Product Safety Commission, as well as the FBI. The FDA's federal budget is in the area of $2.5 billion.

New drugs receive a good deal of attention from the FDA via the New Drug Application or NDA. The drug must be approved and once approved is said to be "safe and effective when used as directed." Also, an advertisement for a drug must exhibit a "fair balance" between benefits and risks.

Critics of the FDA are not convinced that the agency does a good job of keeping the American public safe and healthy. For many free-market thinkers the idea that a government agency can perform such a task is highly questionable.

Then there is the issue of the subterranean agenda of the FDA, which seems to involve ensuring that drug companies are able to market their products at the expense of traditional holistic treatments and nutritional supplements.

Anything that is not drug related seems to come under attack by the FDA sooner or later. The agency recently helped put a number of Amish farmers in jail for producing raw, unpasteurized milk. For such reasons, the FDA is increasingly seen as a rogue agency, out of control, vindictive and abusive of its tremendous authority. It is not likely, according to the critics, that the FDA will change in any significant way, but will continue to deprive consumers of choices and reduce the health potential of millions of people.


Food and Drug Administration (FDA): Site Contributions


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