Vioxx Recall Leads to Regulatory Changes

November 6, 2004

FDA officials announced that they will order a review of the agency's drug monitoring policies in the wake of the withdrawal of Vioxx. The FDA also said it is installing new procedures that will enable their scientists to formally challenge regulatory decisions when they are concerned that public health could be at risk. The new procedure will allow FDA scientists to formally address concerns over safety decisions to a three-member panel that includes outside experts. The panel would then have 30 days to issue a decision on how to proceed with the review in light of the objections.

The FDA was been widely criticized for allegedly ignoring staff warnings about the safety of Vioxx long before it was pulled from the market on September 30, 2004, by its manufacturer, Merck & Co. due to new evidence that Vioxx increases the possibility of heart attacks and stroke.

There is increased pressure from lawmakers and outside groups for the FDA to provide more transparency of its drug review process.

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