FDA official quits in feud over `morning-after' pill

Head of women's health faults unexplained delay in approval of OTC sale

September 01, 2005|By Jonathan D. Rockoff | Jonathan D. Rockoff,SUN NATIONAL STAFF

WASHINGTON - Accusing federal drug regulators of ignoring sound science, a top official at the Food and Drug Administration resigned yesterday to protest the agency's failure to allow sales of the "morning-after" pill without a prescription.

Susan F. Wood said she left her post promoting women's health at the FDA because of the agency's decision last week indefinitely delaying approval of over-the-counter sales of the Plan B pill until it could hear more public comment and study further.

"I couldn't stand by and appear to support the decision the agency made because it wasn't based on science and good clinical evidence," she said.

While Wood emphasized the science in favor of easing access to Plan B, her departure further inflamed political passions surrounding easing access to the pill, which has been caught up in the country's pitched abortion fight.

It reignited the sharp exchanges that followed FDA Commissioner Lester M. Crawford's announcement to delay approval of over-the-counter sales even though the agency had concluded the pill could be sold safely to women 17 and older.

Crawford, who had promised to take action before Sept 1, instead invited 60 days of public comment about how the agency could make sure girls younger than 17 could not obtain the pill without a prescription.

Joining the fray was Sen. Edward M. Kennedy, a Massachusetts Democrat, who praised Wood's resignation as "courageous" while expressing "disappointment" with the FDA's delay.

"When it comes to Plan B, it's high time to put aside right-wing politics and put science and women's needs back in the driver's seat," he said in a statement.

Conservatives countered that advocates of abortion were injecting politics into the FDA's decision-making by rushing Plan B's approval, even though the pill's effect on the health of girls hadn't been studied.

"There are people in the FDA who have put abortion politics above women's health, and thankfully there is one less there now," said Wendy Wright of Concerned Women for America.

In a statement, the FDA expressed its commitment to "protecting and advancing women's health" and cited "significant strides" under Wood's leadership.

"Her decision to leave is unfortunate as we work toward solving the complex policy and regulatory issues related to Plan B. We wish her well in her future endeavors," the statement said.

Plan B is a high dosage of birth control that is supposed to be taken within 72 hours after sex. While some conservatives say taking the pill is essentially equivalent to an abortion, liberals and mainstream medical associations say it's a contraceptive that reduces unwanted pregnancies and abortions.

The drug has been available by prescription since 1999. FDA consideration of its sale over-the-counter has been tied up for two years amid reviews and politicking.

A former postdoctoral researcher at Johns Hopkins, Wood, a biologist, had served as assistant FDA commissioner for women's health for five years. She promoted research into hormone therapy and medication use in pregnancy.

In an interview, Wood emphasized that agency scientists viewed over-the-counter sales of Plan B as safe and effective, the normal standards for approval. A panel of scientists advising the agency had overwhelmingly endorsed the sales.

Wood refused to say FDA officials decided to delay because of politics, instead criticizing them for reaching their decision in private. And she said she was "disturbed" that the issue - and her resignation - was wrapped up in the abortion fight.

"This particular issue shouldn't get caught up in the abortion debate, and the FDA should stick to the standards it's always stuck to," Wood said.

Democratic Sens. Hillary Rodham Clinton of New York and Patty Murray of Washington, who held up Crawford's confirmation until the agency agreed to take action by Sept. 1, repeated their call for Senate hearings.

A spokesman for Sen. Michael B. Enzi, a Wyoming Republican who chairs the Senate Health, Education, Labor, and Pension Committee, said he was reviewing their request and had asked the FDA to explain how it decided to delay.

Seven states have granted some access to the pills without a prescription - Maryland is not among them - and liberal groups are discussing pushing more states to pass such measures or give women advance prescriptions, said Kirsten Moore, president of the Reproductive Health Technologies Project.

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