Depositions Show FDA Subject to Political Pressure in EC Approval

The Food and Drug Administration’s decision not to approve Barr Laboratories’ 2004 petition to make emergency contraception (EC) over-the-counter was unduly influenced by political pressure, depositions of several FDA scientists indicate. The depositions, released on Thursday, are part of the Center for Reproductive Rights’ lawsuit against the FDA for not following standard procedure when reviewing Barr Laboratories’ original petition to make EC over-the-counter for all women.

The deposition of senior agency scientist Florence Houn reveals that then acting deputy commissioner of the FDA, Dr. Janet Woodcock, told Houn that she should “issue a non-approval letter to appease the administration’s constituents,” and that the application to make EC over-the-counter could be reconsidered later. Other FDA scientists, Dr. Curtis Rosebraugh and Dr. Donna Greibel, testified that senior FDA management were actively involved in the review process from the very beginning, which is highly unusual, according to CRR.

“The evidence we have uncovered in the course of deposing a number of FDA scientists and officials reveals that the FDA submitted to political pressure from the Bush Administration in rejecting over-the-counter status from Plan B,” said Simon Heller, the lead attorney for the CRR’s case against the FDA, according to a press release.

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Center for Reproductive Rights 8/3/06; Kaiser Daily WomenÕs Health Policy Report 8/4/06; Deposition of Dr. Florence Houn, released 8/3/06; NPR 8/9/06; Associated Press 8/3/06

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