TortsProf Blog

Editor: Christopher J. Robinette
Widener Commonwealth Law School

Tuesday, May 22, 2007

Hearing on FDA's Role In Evaluating Drug Safety

Thanks to Bill for the welcome!  I am delighted to join him. 

Now for an interesting tidbit about the FDA:  An article in yesterday's New England Journal of Medicine (NEJM) concerning the diabetes drug Avandia is prompting a closer look at the FDA's role in ensuring drug safety.   

  • On Monday, Representative Henry A. Waxman announced that the Committee on Oversight and Government Reform will hold a hearing on June 6, 2007, on the FDA's role in evaluating the safety of Avandia. 
  • Consumers Union also is pointing to the NEJM research on Avandia as support for legislation limiting the FDA's post-market review system. 
  • The FDA has issued a safety alert on Avandia, urging patients to talk to their doctor about continued use of the drug. 
  • Today's New York Times has an article on this issue, which includes a response by the drug's manufacturer, GlaxoSmithKline (Bill adds: GSK has statements on its media page, including a fairly detailed discussion of its long-term clinical trials).


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