16 November 2005

Plan B, the FDA, and "controversial"

As many of you probably know, the Government Accountability Office released a report yesterday outlining their conclusions following an investigation into the FDA's initial decision to deny Over-The-Counter (OTC) status to the emergency contraceptive "Plan B". The GAO concluded that the decision to deny approval for OTC sales of the drug was unusual for several different reasons. The involvement of high-level FDA officials was unusual, as were reports that the decision to deny approval was made prior to the conclusion of the review process. The decision to overrule lower-level FDA offices was unusual, and the justification that was used in denying approval was "novel and did not follow FDA's traditional practices" (GAO report, page 1).

All of those things are troubling, all of them indicate a level of political involvement in a medical decision that is totally unacceptable, and all of them demand further investigation, particularly in light of the foot dragging that is still going on at the FDA.

Here's the part of the GAO report that I find most troubling:
In its comments on a draft of this report, FDA disagreed with three of our findings. First, FDA disagreed with our finding that the involvement of high-level management in the Plan B decision was unusual because their involvement is likely in high-profile and controversial regulatory decisions. (p.6)

The Plan B OTC request was controversial - politically controversial. It was not scientifically controversial. The joint advisory committee and lower ranking FDA officials from three offices that normally would have had the final say on approving the application were all in agreement that the application should be approved. In such cases, it is the job of the FDA management to insulate the approval process from political pressure. It is not their job to bow to it.

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