WASHINGTON (AP) -- The highly regarded women's health chief at the
Food and Drug Administration resigned Wednesday in protest of her agency's refusal
to allow over-the-counter sales of emergency contraception.
Assistant Commissioner Susan Wood charged that FDA's leader overruled his own
scientists' determination that the morning-after pill could safely be sold without
a prescription, and stunned his employees last week by instead postponing indefinitely
a decision on whether to let that happen.
''There's fairly widespread concern about FDA's credibility''
among agency veterans as a result, Wood told The Associated Press hours after
submitting her resignation Wednesday.
''I have spent the last 15 years working to ensure that science informs
good health-policy decisions,'' Wood, director of FDA's Office of Women's Health,
wrote in an e-mail about her departure to agency colleagues. ''I can no longer
serve as staff when scientific and clinical evidence, fully evaluated and recommended
by the professional staff here, has been overruled.''
It was an unprecedented public show of discord for the FDA, and prompted lawmakers
to call for congressional hearings into whether the nation's leading public
health agency allowed politics to trump science in determining the fate of the
morning-after pill called Plan B.
''It is time for the FDA to stop playing games with the health and
well-being of millions of American women,'' said Sens. Patty Murray, D-Wash.,
and Hillary Rodham Clinton, D-N.Y. ''Day by day, the public's confidence in
the FDA's ability to make decisions based on scientific evidence of safety and
efficacy is eroding.''
Sen. Michael Enzi, R-Wyo., who heads a Senate health committee that oversees
FDA, is considering their request for a hearing, and separately has asked the
FDA to explain how and why it reached Friday's decision, a spokesman said.
Another letter from four House Democrats asks President Bush to issue ''a clear
directive'' to federal agencies that all health-related decisions be based on
FDA Commissioner Lester Crawford is out of town, but the agency issued a statement
Wednesday saying Wood had helped make ''significant strides'' in advancing women's
health and that ''her decision to leave is unfortunate as we work toward solving
the complex policy and regulatory issues related to Plan B.''
The morning-after pill is a high dose of regular birth control that, taken
within 72 hours of unprotected sex, can lower the risk of pregnancy by up to
The sooner it's used, the better it works. But because it can be difficult
for women to get a prescription in time, Plan B's maker has been trying for
two years to begin nonprescription sales -- and FDA's latest delay was a surprise:
Crawford won Senate confirmation to begin his job this summer only after promising
senators to make a final decision by Sept. 1.
Instead, Crawford announced Friday that while over-the-counter sales to women
17 and older would be safe, younger teens would still need a prescription because
of concern about whether they could use the drug properly -- and that the agency
didn't how know how to enforce an age limit. So he opened the question to public
comment for 60 days, but wouldn't say how soon after that FDA would rule.
Plan B opponents, who consider the drug tantamount to abortion and have intensely
lobbied the Bush administration to reject over-the-counter sales, praised Crawford's
move, saying easier access to emergency contraception may encourage teen sex.
But contraception advocates decried it, saying easier access could halve the
nation's 3 million annual unintended pregnancies. FDA scientists have publicly
called the pill safe, used by millions of women with few side effects, and in
December 2003 the agency's scientific advisers overwhelmingly backed over-the-counter
sales for all ages.
When FDA first raised the teen concern last year, maker Barr Pharmaceuticals
proposed the age limit, saying it could be enforced just like drugstores enforce
age limits on cigarette sales.
This time around, Wood said the final decision was made not in FDA's usual
manner but ''at the commissioner level ... where most if not all of the professional
staff were excluded.'' Nor has FDA ever raised questions about teen use of other
drugs, she said.
Wood, a biologist, joined FDA's women's health office in 2000, after directing
women's health programs at its parent agency, the Department of Health and Human
Services. She has worked as a research scientist and a prominent congressional