DID THE FDA PLAY DIRTY?

Pharmacy Times, Volume 0,0

Did politics take precedence overscience in the ongoing debate onwhether the morning-after pill, levonorgestrel(sold under the brand Plan B),should be given OTC status? TheGovernment Accountability Office(GAO) is pointing fingers again at theFDA, claiming that the agency rejectedan application to allow OTC sales ofthe morning-after pill months before agovernment scientific review of theapplication was finished. In a statement,the FDA stood by its rejectionand said that the GAO's audit "mischaracterizesfacts."

The GAO's investigation of theFDA's initial rejection found that minutesof a January 15, 2004, meetingindicate that Steven Galson, MD,then acting drug chief, informedemployees that rejection was "recommended"because of the agequestion, even though a review ofthe science was not complete. Wasthere unusual involvement fromhigh-ranking officials in this controversy?During a February 18, 2004,meeting, reviewers told then-Commissioner Mark B. McClellan,MD, PhD, that there was no evidenceto confirm Dr. Galson's concernsabout young teens.

Under normal circumstances, 3 FDA directorswould be responsible for signingoff on the approval or rejection of Plan B.The FDA directors did not do so. Evidenceshowed that they were not asked to signoff, and Dr. Galson did instead, because itwas known that the directors would disagreewith the decision.

The long-running debate stems backto 2003. In December 2003, the FDA'sscientific advisors supported OTC salesof Barr Laboratories' Plan B for all ages.FDA officials rejected the OTC switch inMay 2004, citing no data proving thatanyone under 16 years old could safelyuse the pill without a physician's guidance.In July 2004, Barr amended itsapplication, asking for OTC status onlyfor females ≥16 and by prescription forthose under 16.

In August 2005, the FDA indefinitelypostponed a decision on Plan B becauseagency officials were not surewhether the age restriction was legal orenforceable. Congressional lawmakershave asked Health and Human ServicesSecretary Michael Leavitt to getinvolved to guarantee that the agency'sfinal decision on Plan B is not based onideology.