DID THE FDA PLAY DIRTY?

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Did politics take precedence over science in the ongoing debate on whether the morning-after pill, levonorgestrel (sold under the brand Plan B), should be given OTC status? The Government Accountability Office (GAO) is pointing fingers again at the FDA, claiming that the agency rejected an application to allow OTC sales of the morning-after pill months before a government scientific review of the application was finished. In a statement, the FDA stood by its rejection and said that the GAO's audit "mischaracterizes facts."

The GAO's investigation of the FDA's initial rejection found that minutes of a January 15, 2004, meeting indicate that Steven Galson, MD, then acting drug chief, informed employees that rejection was "recommended" because of the age question, even though a review of the science was not complete. Was there unusual involvement from high-ranking officials in this controversy? During a February 18, 2004, meeting, reviewers told then- Commissioner Mark B. McClellan, MD, PhD, that there was no evidence to confirm Dr. Galson's concerns about young teens.

Under normal circumstances, 3 FDA directors would be responsible for signing off on the approval or rejection of Plan B. The FDA directors did not do so. Evidence showed that they were not asked to sign off, and Dr. Galson did instead, because it was known that the directors would disagree with the decision.

The long-running debate stems back to 2003. In December 2003, the FDA's scientific advisors supported OTC sales of Barr Laboratories' Plan B for all ages. FDA officials rejected the OTC switch in May 2004, citing no data proving that anyone under 16 years old could safely use the pill without a physician's guidance. In July 2004, Barr amended its application, asking for OTC status only for females ≥16 and by prescription for those under 16.

In August 2005, the FDA indefinitely postponed a decision on Plan B because agency officials were not sure whether the age restriction was legal or enforceable. Congressional lawmakers have asked Health and Human Services Secretary Michael Leavitt to get involved to guarantee that the agency's final decision on Plan B is not based on ideology.