The GAO Report on the FDA's Plan B Rejection

So there's been real news on Plan B which I discussed breifly last week and it comes in the form of a GAO report on how the FDA decided not to approve Plan B for over the counter use. The following comes from the report abstract which you can reach here.

GAO was asked to examine (1) how the decision was made to not approve the switch of Plan B from prescription to OTC, (2) how the Plan B decision compares to the decisions for other proposed prescription-to-OTC switches from 1994 through 2004, and (3) whether there are age-related marketing restrictions for prescription Plan B and other prescription and OTC contraceptives. To conduct this review, GAO examined FDA's actions prior to the May 6, 2004, not-approvable letter for the initial application.

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.

The third count is the one that has really come to life as several people have said that the decision to reject the OTC (over the counter) use of Plan B may have been made before the scientific information (the information that the FDA is suposed to make its decision on) had come in. Sources: Report Abstract GAO - November 14 Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual GAO - November 1