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For Your Information: FDA Regulations
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Clinical Testing
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Safety Review of Prescribed Drugs
Vioxx and the COX-2 Family
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Major FDA Laws 1906 - present
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About the Author

This is a purely informational site only, intended to give an overview of current federal FDA drug safety regulations. In no way is this site affiliated with the United States government or the FDA.

           The United States pharmaceutical industry invested $39 billion in research and development of drugs in 2004 alone. Such a profound and growing market needs oversight into product development. The safety of drugs is something which cannot be compromised.

 

           Recently, a shadow of doubt has been cast over the United States’ governing Food and Drug Administration. Most notably, Vioxx, an effective anti-arthritic, has been removed voluntarily by its manufacturer, Merck & Co. Other anti-arthritics in the same class (cyclooxygenase-2, or COX-2, inhibitors) have been found to carry similar cardiac risks.2

 

           How were these risks not detected before the drug was approved for the general public? Research conducted during the FDA-required clinical phases did not appear to alert scientists of its potentially fatal side effects. Were the clinical reports flawed or incomplete? Is the FDA safety testing process successful in preventing unknown harmful side effects?

 

           Despite efforts by clinical researchers and the FDA’s Center for Drug Evaluation and Research (CDER), often no drug can be completely evaluated and approved without carrying a risk of harmful side effects. However, it remains the absolute duty of the FDA to maintain constant watch over pharmaceutical companies to ensure public safety.

 

 

 

 

 

 

 

 

 

 

 

2. Aschenbrenner, D. (2005). Cox-2 inhibitors: cardiovascular risk possibly a 'class effect'. American Journal of Nursing, 105(6), 30-38.

The Food and Drug      Administration
Protective Legislation
  • 1906 - Pure Food and Drug Act was the United States’ first attempt at establishing consumer health protection. It had, by today’s account, minimal standards for purity. In addition, the only regulation in labeling belonged to morphine-based substances. The Act did not empower the growing Office of Drug Control, the precursor to the CDER, to remove unsafe drugs from the market.
  • 1938 - Federal Food, Drug, and Cosmetic Act was instituted by the Department of Health and Welfare. Its’ intention was to not only further identify strengths and purities in prescription and non-prescription drugs, but to institute a drug safety regulation process. This Act is still the overriding law ensuring consumer safety today.
  • 1962 - Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act were passed by President Kennedy. These provisions demanded that pharmaceutical companies demonstrate the safety of their product prior to marketing to the public.

Copyright 2005 C.L. Burrill
 
site last updated 19 August 2005