Does the FDA Need to be Overhauled?
By John Mack (Bio)
SUMMARY
The Vioxx withdrawal put the Food and Drug Administration (FDA) under the spotlight. There were allegations that the FDA was in cahoots with Merck in keeping Vioxx problems under wraps (see, for example, “Will COX-2 Inhibitors Crash and Burn?“). A New York Times story reported that “Members of Congress, an internal F.D.A. whistleblower and prominent medical journals have said the agency is incapable of uncovering the perils of drugs that have been approved and are in wide distribution.” (“At F.D.A., Strong Drug Ties and Less Monitoring,” NYT, December 6, 2004).
Pharma Marketing News recently hosted a survey of pharmaceutical professionals, healthcare professionals, and the general public to get a better idea which reforms, if any, they would like to see implemented at FDA. The results are summarized in this article.
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PMN42-05
Issue: Vol. 4, No. 2: February 2005
Word Count: 2131
TOPICS: Corporate Compliance/Government Regulation/Industry Guidelines | Direct-to-Consumer (DTC) Advertising & Marketing
