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More Evidence of Improper Involvement in FDA’s EC Decisions

Court transcripts released today indicate that the most recent Commissioners of the Food and Drug Administration (FDA) were unusually involved in decisions regarding the over-the-counter application for the emergency contraceptive Plan B. The Center for Reproductive (CRR) rights has filed suit against the FDA over the delay in a decision on the Plan B application for over-the-counter status, and the case is moving forward in New York. The suit alleges that the Food and Drug Administration (FDA) violated a statutory deadline for making a decision on whether to allow over-the-counter sales of the emergency contraceptive Plan B, and in doing so, violated women’s constitutional rights to privacy and equal protection.

The depositions of two senior FDA officials, made public by CRR, revealed that the normal decision-making process was ignored, as former Commissioner Mark McClellan raised objections about the drug’s safety for adolescents during his tenure, and Lester Crawford personally took the decision out of the hands of senior staff. Dr. Janet Woodcock, a deputy FDA commissioner, testified that her questions about the application were brushed off, saying, “Ordinarily, I would have been more involved, but not in all cases. In this case, I was not involved,” reports Reuters. Dr. Steve Galson, director of the FDA’s Center for Drug Evaluation and Research, said, “Dr. Crawford … told me that he was concerned about where we were heading because he knew that I was heading toward this recommendation, and he told me that he was going to make the decision on what to do with the application,” according to the Los Angeles Times. This testimony supports the findings of the Government Accountability Office (GAO) report, which found that the process surrounding Plan B was “unusual” and marked by the involvement of high-level officials. Crawford was to be deposed yesterday, and McClellan will be deposed month.

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Sources:

Center for Reproductive Rights 5/2/06; Feminist Daily News 11/15/05, 1/11/06; Los Angeles Times 5/25/06; Reuters 5/25/06