REPORT BY GAO BLASTS FDA'S PLAN B DECISIONMAKING
An unreleased federal report bolsters allegations that the FDA made a political rather than a scientific decision when it delayed Barr Pharmaceuticals' application to sell the Plan B contraceptive without a prescription, congressional sources say.
The Government Accountability Office's (GAO) initial report on the FDA's handling of Plan B (levonorgestrel) shows the agency took numerous unprecedented steps to inject politics into its decision, according to congressional staff who have reviewed the GAO's findings. While the report will not be publicly available until November, the document was on display for lawmakers and their staff beginning Oct. 12. Staffers say the GAO didn't distribute copies of its preliminary findings due to the "sensitivity" of the subject.
The GAO concluded the FDA took authority for the Plan B decision away from the staffers that usually make such decisions, made an initial decision to reject the application before internal and external reviews were completed, and delayed its decision to consider issues such as adolescent promiscuity, one Hill staffer said.
Specifically, the report found the FDA gave final decisionmaking over Plan B to Center for Drug Evaluation and Research Director Steven Galson, instead of granting that authority to officials in the Offices of Drug Evaluation III and V, and the Office of New Drugs, which typically handle drug approvals.
The GAO concluded that the FDA's actions on Plan B represented a significant departure from standard agency policy and indicated potential problems in the agency's review of Barr's application. The FDA's later rejection of an independent advisory panel's recommendation that Plan B be sold OTC also was unprecedented, the GAO found. According to the report, of 23 drugs recommended for OTC sale by FDA advisory panels over a 10-year period from 1994 to 2004, Plan B was the only one the agency later rejected.
Former FDA Commissioner Lester Crawford recently announced that the agency was delaying Barr's OTC application, citing lingering questions. Crawford had argued that the most pressing question the agency is facing is whether or not it would be possible to ensure that only people 17 and older would be able to buy the drug without a prescription.
The agency has been under fire for its handling of Plan B, with building congressional pressure on the FDA to reconsider its decision. A bipartisan coalition of 62 House members sent a letter last week to the agency demanding that the FDA grant the drug OTC status.