FDA Acting Commissioner Indicates EC OTC Will Be Approved

The nominee to become the next Food and Drug Administration (FDA) Commissioner indicated at a confirmation hearing yesterday that the FDA will approve over-the-counter status for emergency contraception (EC). “The science part is generally done,” said Lester M. Crawford, who is currently serving as acting commission of the FDA, according to the Washington Post. “We’re just now down to what the label will look [like]. This is going to be a very unusual sort of approval.”

Several Senators questioned Crawford aggressively about the FDA’s continued delay on deciding whether or not to approve over-the-counter (OTC) status for Plan B, a brand of emergency contraceptive produced by Barr Laboratories. Barr had to resubmit its application for OTC status in July to include dual-labeling, which would allow nonprescription access for women ages 16 and over, and prescription-only access for those aged 15 and under. In January, the FDA indefinitely delayed its decision.

Senator Hillary Clinton (D-NY) expressed her concern that the agency seemed to be relying on politics rather than science in making this decision. “I’m hopeful we will reverse what appears to be a dangerous slide into political opinion rather than scientific evidence,” she said, according to the Post. Crawford said that he anticipated a decision on EC OTC within weeks, rather than days, and that he could not guarantee a decision before the Senate Health, Education, Labor, and Pensions Committee voted on his nomination on April 13, the New York Times reports.

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Washington Post 3/18/05; New York Times 3/18/05; Reuters 3/17/05; Feminist Majority Foundation

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