September 01, 2005
FDA official quits over pill delay
Wood blames politics for refusal to approve morning-after drug
By Diedtra Henderson, Globe StaffWASHINGTON -- A senior Food and Drug Administration official resigned yesterday to protest the agency's refusal to allow over-the-counter sales of emergency contraception.
Susan F. Wood, director of the FDA's Office of Women's Health, detailed her decision in an e-mail to co-workers that was quickly distributed by Reproductive Health Technologies Project, a Washington group that lobbies for access to contraception.
Wood, in an interview, said the FDA's credibility was at stake since it has twice overruled staff's recommendation to permit the morning-after pill Plan B to be purchased without a prescription. She said those decisions will undermine women's health.
Last summer, the FDA overruled agency reviewers and federal advisers in denying Barr Laboratories' application to sell Plan B over the counter without age restrictions. In July, Barr tweaked its application, targeting over-the-counter sales to women 16 and older. Late Friday, FDA commissioner Lester Crawford said the agency would indefinitely delay its decision. FDA scientists determined women 17 and older could use the pill safely without a doctor's guidance, but the agency is unclear about how to enforce the age restriction.
''I'm not one to seek out this attention. The decision [to resign] was symbolic," Wood said. ''We've really let FDA down, and we've let the public down if we let this kind of decision move forward unchallenged." The FDA had been slated to decide whether to allow the sale of Plan B by Jan. 21, the eve of the anniversary of the Supreme Court's Roe v. Wade decision that legalized abortion. But the prospect of young girls purchasing pills without a prescription has become a moral and political land mine for regulators.
''This is talked about as a delay but, in reality, it's a denial for all women," Wood said. She said Crawford's pronouncement on Friday was so closely guarded that most FDA staffers -- including herself -- did not learn of it until that afternoon.
Politics has trumped science in other FDA decisions, Wood said, but two years of maneuvering on Plan B has taken it to ''a new height." Crawford's disclosure is ''not based on the science and it's not based on the reality that use of this product prevents abortion if you can prevent an unintended pregnancy," she said.
The FDA, in a press release, called Wood's resignation ''unfortunate" and described the agency as ''committed to protecting and advancing women's health."
The morning-after pill packs the potency of a high dose of regular birth control. It is most effective when taken shortly after unprotected sex. FDA scientists concluded the pills, already used by more than 2.4 million American women, are safe. Federal advisers overwhelmingly agreed, and in December 2003 they backed over-the-counter sales with no age limitations.
Seven states already permit women to buy the pills directly from certain pharmacies where pharmacists write the prescriptions. Massachusetts is poised to become the eighth state to permit such purchases if legislators override Governor Mitt Romney's veto of legislation allowing the sales.
Some observers say Wood's departure is especially significant because she championed women's health issues inside and outside the FDA. It also fuels ongoing criticism that the agency ignored science in its handling of Plan B.
''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 wrote in her e-mail, echoing qualms expressed by Dr. John K. Jenkins, director of the FDA's Office of New Drugs, when FDA leaders overruled staff last summer.
''The FDA and the American people lost a strong voice for scientific integrity," said US senators Patty Murray, Democrat of Washington, and Hillary Rodham Clinton, Democrat of New York, in a press release. ''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."
Murray and Clinton are seeking a congressional hearing on the FDA's handling of Plan B, but the Senate Health, Education, Labor and Pensions Committee has not set a date.
US Senator Edward M. Kennedy, Democrat of Massachusetts, called Wood's resignation ''courageous" and criticized the FDA's delays as ''indefensible."
A women's health advocate who has known Wood since the 1990s said her departure amounts to a vote of no-confidence in the FDA.
''Losing somebody like that is a big deal," said Diana Zuckerman, president of the National Research Center for Women and Families. ''It shows such a lack of confidence in the agency. If she thought she could do good there, she would have stayed."
Wood, a former research scientist at Johns Hopkins University School of Medicine's department of neuroscience, worked for the Congressional Caucus for Women's Issues from 1990 to 1995.
After helping to develop women's health policy at the US Department of Health and Human Services, she became FDA's director of the Office of Women's Health in November 2000.
Among other issues, Wood highlighted the public health implications of pregnant women metabolizing drugs differently than women who typically test drugs in clinical trials.
While she ended her resignation letter with the hope of working with FDA ''in a different capacity," for now, Wood is unemployed.
''You close these sort of things with 'and I'll be doing x and y.' Well, I don't have that x and y yet," she said. ''I don't have a soft landing plan."
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