GAO - FDA: Decision Process to Deny Initial Application for OTC Marketing of the Emergency Contraceptive Drug Plan B Was (gasp!) Unusual

(via The Health Care Blog, link goes to original GAO report.)

The Plan B decision was not typical of the other 67 proposed prescription-to-OTC switch decisions made by FDA from 1994 through 2004. The Plan B OTC switch application was the only one during this period that was not approved after the advisory committees recommended approval. The Plan B action letter was the only one signed by someone other than the officials who would normally sign the letter.

The Acting Director acknowledged to GAO that considering adolescents� cognitive development as a rationale for a not-approvable decision was unprecedented for an OTC application, and other FDA officials told GAO that the rationale differed from FDA�s traditional practices.

Small, but significant victory for Science.

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