Agency official's departure is a troubling sign, observers warn.

The US Food and Drug Administration (FDA)'s refusal to endorse the controversial 'morning-after' pill signals a troubling shift in the agency's approach to women's health, experts warn.

I found it deeply disturbing that science was not a part of the decision. Susan Wood,, former director, FDA's Office of Women's Health

The FDA's Reproductive Health Drugs Advisory Committee concluded in 2003 that the Plan B contraceptive—a high dose of hormones that prevents pregnancy after unprotected sex—is safe and effective. But in late August, FDA commissioner Lester Crawford overruled both agency scientists and outside advisors and announced that the FDA would seek more public comment before allowing girls 17 years of age and older to buy the drug without a prescription. The drug must be taken within 72 hours to be effective.

Four days later, Susan Wood, director of the FDA's Office of Women's Health, resigned in protest. “Since I was the face of women at the FDA, I couldn't stand by when I found it deeply disturbing that the science was not a part of the decision,” she says.

Some observers predict that her departure will leave the FDA without a strong proponent for women's health. The Office of Women's Health, launched in 1994, does not have regulatory powers, but its staff help shape FDA policies on issues such as guidelines for mammography and the participation of pregnant women in clinical trials.

Wood says she acted to maintain her credibility. It is not unusual for agency officials to reject recommendations, she says, but she found it improper for the commissioner to do so without consulting staff. “The thing that disturbed me is that it didn't appear that any of the professional staff knew what was going to happen,” she says.

The FDA's decision is a clear example of science losing out to the Bush administration's conservative social agenda, some activists note. “Politics is overwhelming science more often than ever before,” says Diana Zuckerman, president of the nonprofit activist group National Research Center for Women & Families in Washington, DC.

But at least one group is applauding Wood's departure. Wendy Wright of the Washington, DC–based Concerned Women for America, which pledges to apply biblical principles to public policy, says birth-control patches and abortion drugs are unsafe, but Wood did nothing to remove them from the market.

In a statement on 26 August, Crawford said that the FDA needs to review potential legal and logistical issues, such as how to enforce age restrictions. But those details could have been worked out in earlier deliberations, notes committee chair Linda Giudice.

In any case, Giudice says, Wood's departure is a loss for women. “Without that voice, I'm concerned that women's health is not going to get the focus that it has in the past.”