Vioxx: FDA Statement on Recent Allegations (cont.)

Fourth, FDA has a well-documented and longstanding commitment to openness and transparency in its review of marketed drugs. Indeed, the post-market review of Vioxx and antidepressants were initiated and funded by FDA and managed by its Office of Drug Safety. That is evidence that the system is working. Even so, two weeks ago I announced additional steps to strengthen that program in the form of a major initiative designed to improve the monitoring of drug products recently on the market.

The major components of that FDA initiative include:

  • Sponsoring a major study of the Drug Safety System by the prestigious Institute of Medicine;
  • Appointing a permanent director for the Office of Drug Safety;
  • Conducting a series of workshops and meetings on drug safety and risk management; and
  • Publishing risk management guidances

Let me emphasize the importance of scientific peer review in the management of drug risks. Peer review is so important that, as part of this drug safety initiative, we are also improving our process for ensuring that internal differences of scientific opinion are fully incorporated into the FDA's decision-making process.

Science at FDA, as elsewhere, typically proceeds by frank discussion and open exchange, followed by a consensus. The organization reaches its conclusion and everyone carries it out.

There are times when honest scientific disagreement cannot be resolved, however, and such disagreements can have a potentially significant public health impact. That is why our new program provides for a review by an ad hoc panel not directly involved in the decisions, by FDA, and by outside experts.

FDA encourages open and vigorous internal debate about the often difficult scientific questions it routinely faces. In the end, we must weigh the evidence -- in this case the benefits and risks of cox-2 inhibitors -- and then decide on behalf of our citizens whether the products should be available. It is a daunting task, and it is one that the FDA has been -- and continues to be -- committed to carrying out every day.

Source: FDA Press Release, November 17, 2004

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Last Editorial Review: 11/22/2004