Plan B intrigue

A report by the Government Accountability Office suggests that the decision to block over-the-counter sales of the contraceptive Plan B was more political than scientific. Observe:

While FDA followed its general procedures for considering the application, four aspects of FDA’s review process were unusual. First, the directors of the offices that reviewed the application, who would normally have been responsible for signing the Plan B action letter, disagreed with the decision and did not sign the not-approvable letter for Plan B. The Director of the Office of New Drugs also disagreed and did not sign the letter. Second, FDA’s high-level management was more involved in the review of Plan B than in those of other OTC switch applications. Third, there are conflicting accounts of whether the decision to not approve the application was made before the reviews were completed. Fourth, the rationale for the Acting Director’s decision was novel and did not follow FDA’s traditional practices.

Four more reasons conservative sexual mores and smart medicine don’t mix.

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