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Statement regarding the GAO report on Plan B 

The Federation of American Scientists is deeply troubled about the findings in the November Government Accountability Office report on the decision process used to evaluate the emergency contraception pill “Plan B” for over the counter status.

The GAO specifically found that:

  1. 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.
  2. FDA’s high level management was more involved in the review of Plan B than in those of other over the counter switch applications.
  3. there were reports that the decision to reject the application was made before the scientific review was completed.
  4. the rationale for the acting Director’s decision did not follow the FDA’s traditional practices. The FDA’s decision process was different from the 67 other prescription to over-the-counter decisions made between 1994 and 2004 including unprecedented consideration of the cognitive development of adolescents who might take the drug.

Approval of this particular drug has important political and social implications that should be openly debated. However, these concerns should not skew the scientific review process and the non-traditional approval process and reports of political pressure from FDA management are of deep concern. The nation relies on the FDA to evaluate rigorously the scientific evidence for drug safety prior to approval. Any reports of social or political pressure being placed on the process should be vigorously investigated and steps immediately taken to ensure the integrity of the scientific review process. Moreover, there is a reoccurring pattern of interference in the review of scientific data at many agencies within the government. FAS feels that there is cause for swift action by Congress and the administration to put an end to it.

The full report can be found here.

Report highlights can be found here.

November 16, 2005 10:01 AM

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