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Drug agency accused of political bias

Women's health director quits over ‘morning after’ pill delays

Washington DC

A top official at the US Food and Drug Administration (FDA) resigned last week in protest at the agency's failure to make a ‘morning after’ contraceptive more readily available. Her departure fuelled charges that the agency has surrendered its scientific independence to conservative pressure from the administration of President George W. Bush.

Susan Wood, who directed the FDA's Office of Women's Health, wrote in a 31 August e-mail to her colleagues: “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 told Nature that the FDA's recent decision to delay making the ‘morning after’ pill Plan B (levonorgestrel) available over the counter bore the hallmarks of political interference. “It was very unusual for the commissioner of the FDA to essentially overrule the recommendation of all of the professional staff,” she says.

Campaigners have found FDA delays over the ‘morning after’ pill Plan B hard to swallow. Credit: WOMEN'S CAPITAL CORP./GETTY

The drug's manufacturer, Barr Pharmaceuticals in Woodcliff Lake, New Jersey, originally applied in 2003 to get Plan B's prescription-only status changed so that it would be available over the counter. The FDA rejected this in 2004, going against its own staff and an outside panel of expert advisers, who voted 23–4 in favour of the change. Barr then followed the FDA's advice by resubmitting the application, this time asking for the contraceptive to be available over the counter only to women over 16.

A promised decision on that application was delayed late last month, when FDA commissioner Lester Crawford announced that Plan B presented “unique” regulatory obstacles.

Activists who believe that life begins at conception have vehemently opposed making access to the contraceptive easier. “Thank goodness there is now one less political activist at the FDA who puts radical feminist ideology above women's health,” says Wendy Wright, senior policy director at Concerned Women for America, a conservative activist group in Washington DC.

Pressure has also come from the other side. Two Democrat senators this spring blocked Crawford's nomination as FDA commissioner until they were guaranteed a final decision on Plan B's over-the-counter availability by 1 September (see Nature 436, 442; 2005). The two senators, Hillary Clinton (New York) and Patty Murray (Washington), expressed outrage over the new delay, calling it “a breach of faith”.

“The president now has his FDA administrator, but the American public still does not have an answer on Plan B,” they wrote in a letter on 30 August to Michael Leavitt, the Secretary of Health and Human Services.

In a similarly angry editorial, published online last week by The New England Journal of Medicine (doi:10.1056/NEJMp058222), editor-in-chief Jeffrey Drazen and others wrote that the FDA's actions have “made a mockery of the process of evaluating scientific evidence, disillusioned many of the participating scientists both inside and outside the agency [and] squandered the public trust.”


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Barr Pharmaceuticals

Susan Wood's resignation press release

FDA's external advisers approve Plan B

Crawford letter on Plan B

Concerned Women for America

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Wadman, M. Drug agency accused of political bias. Nature 437, 179 (2005).

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