FDA official quits; policy on ‘morning after’ pill cited

A senior women's health official at the Food and Drug Administration resigned on Wednesday to protest the agency's failure to approve over-the-counter sales of a "morning-after" contraceptive despite favorable recommendations from staff scientists.

The FDA said Friday it was indefinitely postponing a decision on Barr Pharamceuticals Inc.'s bid to sell the Plan B contraceptive without a prescription.

A decision that "continues to limit women's access to a product that would reduce unintended pregnancies and reduce abortions is contrary to my core commitment to improving and advancing women's health," said Susan Wood, the FDA's assistant commissioner for women's health and director of its office of women's health.

"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. I therefore have submitted my resignation effective today," Wood said in an e-mail to colleagues, reports Reuters.

According to Bloomberg, the FDA has put off since January a decision on Barr's current application for over-the-counter sales of Plan B to women 17 and older. The agency on Aug. 26 said it would seek further comment, saying it didn't know how to ensure that people 16 or younger could get the drug only with a prescription.

An FDA statement said Wood's “decision to leave is unfortunate as we work toward solving the complex policy and regulatory issues related to Plan B.”

Woods was the FDA's director of the Office of Women's Health and assistant commissioner for women's health. The FDA said it had made “significant strides” in advancing women's health under Wood's leadership. “We wish her well in her future endeavors,” the statement said.

Clinton and U.S. Senator Patty Murray, Democrat of Washington, said in a joint statement the resignation confirms that “the science has taken a backseat to politics.”

“It is deeply disturbing that an agency long recognized for making decisions based on sound science has become so politicized that one of its most widely respected, long-serving veterans would feel disillusioned enough to quit in protest,” they said in a joint statement.