Regulatory Considerations in the Post-Vioxx Era

| 01 December 2009

The US environment for drug development and registration has evolved as a result of many significant and public events that span the course of the past century. In the early 1900s, public outcry following the exposure of deplorable conditions in meat packing plants and false claims about patented medicines prompted enactment of the Pure Food and Drug Act of 1906. This federal law ultimately provided the foundation for what is now the Food and Drug Administration (FDA). In the 1930s, public awareness of the need for greater federal regulation of drug safety resulted from the sale of a poisonous elixir formulation of sulfanilamide: this national tragedy prompted Congress to pass the Federal Food, Drug, and Cosmetic Act of 1938, which required premarket demonstration of a new drug's safety. The 1960s brought a similar public health scare when evidence of the teratologic effects of thalidomide became known. Although never approved for use in the US, thalidomide was available for use in some other countries and was being studied in the US. The Kefauver-Harris Amendments were subsequently passed by Congress, requiring premarket evidence of efficacy and safety of all new drugs, both prescription and OTC, and requiring adverse reaction reporting for the first time in US history. In the early part of the 21st century, another significant set of circumstances again led to increased public awareness about the safety of pharmaceutical products. Media, Congress, consumer advocates, watchdog groups and the pharmaceutical industry were engaged in dialogue. Would the existing drug development and FDA approval process prove to be sufficient to maintain public confidence in marketed drugs?


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