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Former FDA Head Deposed on Plan B

This week, the Center for Reproductive Rights (CRR) released the deposition of former Food and Drug Administration (FDA) Commissioner Lester Crawford, which was made on May 24. CRR 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.

Crawford testified about the August 2005 decision to delay the approval and consider requiring prescriptions for women under 17, saying that “There was no — no talk of denial, there was talk of trying to get straight what the enforcement procedures would be,” according to the Associated Press. Furthermore, he said that he expected Plan B to be approved within six to nine months of the August 2005 delay, once the agency had figured out how to enforce age-based restrictions. Crawford unexpectedly resigned within weeks of the August delay, and still no decision has been made by the FDA on over-the-counter status for Plan B. The deposition of Crawford follows the depositions of two high-level FDA career scientists – Janet Woodcock and Steven Galson – who felt that the Plan B decision was unusually controlled by Crawford and Mark McClellan. McClellan, who was the FDA Commissioner prior to Crawford, was deposed on Tuesday, and his testimony will likely be released in the coming weeks.

In other developments regarding the Plan B application, the FDA denied a citizens’ petition to approve Plan B for over-the-counter sales last week. According to a letter from the FDA, the petition, dated February 14, 2001, was denied because it did not contain “sufficient data to satisfy the statutory requirements.”

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Sources:

Associated Press 6/13/06; Center for Reproductive Rights 6/12/06; Kaiser Network 6/13/06, 6/14/06; Letter from FDA to CRR Representatives, 6/9/06