Dying for Regulatory Reform

Dying for Regulatory Reform

Miller article in FDLI Update
February 28, 2005

 Full article available in pdf format

Congress has a long and ignoble history of exaggerated legislative responses to perceived health crises. They seem to be at it again.<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />

 

In 1938, after a hastily-marketed drug containing an untested solvent (diethylene glycol, a potent poison) killed more than a hundred people within a few days, Congress introduced a requirement for the premarketing demonstration of safety (but not effectiveness) for new drugs.

 

The next pivotal event in <?xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" />U.S. drug regulation came a quarter-century later in response to birth defects caused by the sedative thalidomide—although the drug was never approved for marketing in the United States, and the vast majority of adverse events occurred in Europe. Whereas under the 1938 statute a product could be marketed unless the Food and Drug Administration (FDA) actually denied approval of the new drug application (NDA), the 1962 drug legislation imposed important new constraints and requirements on drug sponsors. For the fi rst time, all human testing of new drugs, all drug advertising, and all labeling had to be reviewed and precleared by FDA, and the agency also promulgated regulations for good manufacturing practices (GMPs).