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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