OC label changes also at issue: FDA draws fire on failed OTC bid for Plan B; Government official cites lack of safety data, denies bowing to political pressure.(News)

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Labeling changes for combined oral contraceptives as proposed in a recent and controversial FDA draft guidance would further fuel that agenda, they say.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 data concerning safety, and that his signature on the "not-approvable" letter sent to Barr Research, the maker of Plan B. marks a departure from usual protocol. Dr. Galson does not usually sign regulatory action letters. Because his opinion on the adequacy of the data in young adolescents differed from that of the review staff, he made the decision to take final action within the Office of the Center Director, according to information on the FDA Web site.

Dr. Galson also denied bowing to political pressure, stating that the decision was made entirely within the Center for Drug Evaluation and Research, and that the decision does not preclude future OTC approval for Plan B. He declined to elaborate on the specific type of data required for such approval, however.

Obtaining any data in those under age 14 years will be a daunting task, said Dr. David F. Archer, professor of ob.gyn. at Eastern Virginia, Medical School. Norfolk. "The government is setting up a dual standard," he said, explaining that institutional review boards are "very unhappy" to do studies in younger women.

Furthermore, women younger than age 16 who are menstruating are biologically considered adults in terms of ovarian function, and related data from women older than age 16 are applicable to those younger than age 16, he said.