by Brian Wolfman
Federal prescription drug oversight was significantly deregulated by the Food and Drug Modernization Act of 1997 (FDAMA), which was signed by President Clinton on November 21, 1997. Among other things, section 127 of FDAMA eliminated FDA authority over drug compounding companies, leaving regulatory oversight to state law. In theory, compounding involves only the production of a particular drug to fit the unique needs
of a patient by combining or processing already approved ingredients. For instance, a compounder might re-process an FDA-approved drug to eliminate an inactive ingredient to which the patient is allergic.
Before FDAMA was enated, then FDA Commissioner David Kessler testified against exempting compounders from FDA regulation. Current FDA Commissioner Margaret Hamburg wants FDA oversight restored.
Last night, "60 Minutes" aired an expose on compounding, focusing on one compounding company that, absent any FDA oversight, produced unsterile drugs that killed and permanently injured many people. To watch the story, go here or click on the embedded video below.
