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COPYRIGHT 2004 International Medical News Group
The Food and Drug Administration's recent decision against over-the-counter status for the emergency contraceptive pill known as Plan B enraged many women's health advocates, who say the decision marks a departure from science and represents a Bush administration agenda that seeks to diminish women's reproductive rights.
Labeling changes for combined oral contraceptives as proposed in a recent and controversial FDA draft guidance would further fuel that agenda, they say.
The decision against OTC status for Plan B came on May 7, 3 days after the comment period for the OC labeling changes ended. Despite an FDA advisory panel vote of 23-4 in favor of OTC status for Plan B, Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, decided against OTC approval.
He cited a lack of sufficient evidence regarding the effects of OTC availability of emergency contraception on women who were 14-16 years old and a lack of any data in those younger than 14 years as the reason for his decision. He acknowledged during a teleconference sponsored by the FDA that he was not in agreement with his review staff or the FDA advisory committee with regard to the sufficiency of...
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