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FDA official quits over plan decision

WASHINGTON – The head of the Food and Drug Administration Office of Women's Health resigned Tuesday over the agency's failure to approve over-the-counter sales of the morning-after birth control pill Plan B for females 16 and older.

Susan F. Wood said FDA Commissioner Lester Crawford disregarded advice of the agency's professional staff when he announced Friday that the agency would delay a decision on the pill for at least 60 more days.

"I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled," Wood said in an e-mail to other FDA employees.

The e-mail was made public by the Society for Women's Health Research, an advocacy group, which also lined up press interviews for Wood.

She said late Tuesday that Crawford told her he was sorry she was quitting but respected her decision.

The agency issued a brief statement, saying Wood's decision to quit was "unfortunate."

Democratic Sens. Hillary Rodham Clinton of New York and Patty Murray of Washington immediately called for committee hearings into FDA's handling of a manufacturer's request for permission to market Plan B over-the-counter to females 16 and over.

Currently licensed for use under a doctor's prescription, the drug can reduce the likelihood of becoming pregnant by 89 percent when taken within 72 hours of a single episode of unprotected sex, according to Barr Pharmaceuticals Inc.

Barr, one of two companies that market the drug, has been trying since 2003 to get it approved for nonprescription use. Women's health groups and choice advocates have supported the request, claiming Plan B reduces the incidence of unintended pregnancies and abortions.

In announcing that the agency would seek public comment on the issue for 60 days before going ahead with a decision, Crawford said he was concerned about how to enforce a rule that would make the pill freely available to some females while requiring others to use it only under a doctor's orders.

Jeff Nesmith can be e-mailed jeffn(at)coxnews.com