Normal Limits

"Chance is the very guide of life"

"In practical medicine the facts are far too few for them to enter into the calculus of probabilities... in applied medicine we are always concerned with the individual" -- S. D. Poisson

November 14, 2005

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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