By Cara Solomon
Seattle Times
February 10, 2006

The whole thing is still stunning to Susan F. Wood.

She worked so hard, for so long, on so many fronts. She pushed to include more women in medical trials. She helped start a long-term study on women's health, looking at everything from hormones to heart disease.

And now here she is, famous for an issue that rarely captured her attention in the 15 years she was involved in political life. Famous for the stand she took on birth control.

At the University of Washington today, Wood will tell the story of how she resigned her post in August as assistant commissioner for women's health and director of the Office of Women's Health at the Food and Drug Administration.

She was protesting the agency's decision to delay approval of Plan B, also known as "the morning-after pill," for over-the-counter (OTC) sales. That decision to delay approval went against the advice of an expert scientific panel within the FDA, which had recommended the drug for OTC approval years earlier.

Difficult decision

At a Queen Anne cafe Thursday, Wood said she was still trying to grasp the agency's reasoning. "If this were an abortion issue, I would at least understand where it was coming from," said Wood, 47, a scientist by training.

Plan B is a series of higher-dose birth-control pills women can take within the first 72 hours after unprotected sex. Advocates say it will reduce the numbers of unwanted pregnancies and abortions. But opponents believe it would encourage teenage promiscuity. Some also see it as an abortive agent because, like some other forms of birth control, Plan B can prevent a fertilized egg from attaching to the uterine wall.

Public lecture

Dr. Susan F. Wood

The former assistant commissioner for women's health and former director of the Office of Women's Health at the U.S. Food and Drug Administration will speak today at the UW about the importance of science and medical evidence in health-policy decision making by federal agencies.

Topic: "Women's Health: Emergency Contraception and the FDA"

Time: 2 p.m. today.

Place: Hogness Auditorium, A-420 Health Sciences Building on the University of Washington campus.

Cost: The free lecture is open to everyone.

Women have been able to get the emergency contraceptive with a doctor's prescription since 1999. Washington state was among the first to give pharmacists the power to dispense it, provided they had gone through training.

Sen. Patty Murray, D-Wash., among other lawmakers, has pushed hard to make Plan B more readily accessible. Some women find it difficult to get a prescription within the 72-hour time frame when the drug is most effective, advocates say. Other women run into resistance from doctors and pharmacists who oppose the use of Plan B.

An expert panel within the FDA recommended approval of Plan B for OTC use in 2003. But the agency later rejected the application over concerns about safety in the teenage population. The maker of the drug then revised its application to include only people older than 17.

In late August, the final decision came down: The FDA was prepared to approve the drug, but only after developing a federal regulation giving it OTC status for adults but keeping it prescription-only for young teens. That process could take years, Wood said.

In the days after the announcement, Wood said, her slow-burning temper snapped. She was reluctant to leave her colleagues and work. But in the end, she could see no way to change the agency's decision. And she said she could not stand behind a decision that went contrary to the advice of the FDA's scientists.

"I couldn't look at myself in the mirror," she said.

Opponents of Plan B welcomed her decision to leave. They described her as an activist with a pro-choice agenda.

"I think her resignation made a lot of women safer in this country," said Dan Kennedy, CEO of Human Life of Washington, the state affiliate of the National Right to Life.

"Pushed aside"

Wood began her career as a research scientist at Johns Hopkins University, moving into political life in 1990. She worked for the Congressional Caucus for Women's Issues, then became director for policy and program development at the U.S. Health and Human Services' Office on Women's Health. She took the job at the FDA in 2000.

None of this prepared Wood for the cultlike status she has in some circles now. For a mild-mannered scientist, she said, it can be a bit overwhelming. She has found herself on a countrywide speaking tour, sponsored by the Reproductive Health Technologies Project.

The work has taken her far from family in Maryland. One of these days, Wood hopes to get back into government service. For now, the tour is an opportunity to encourage some outrage in the public over what she sees as an abuse of power.

Wood is convinced the agency's decision came from some higher level of the government, that the FDA would not otherwise ignore its own experts.

"Their recommendations, their advice, their knowledge of what was going on was pushed aside," Wood said. "That should worry people."

There have been calls for a congressional investigation into the FDA's decision on Plan B, she said. But there's been no momentum so far.

Wood said it is crucial that the FDA remain independent from outside influence. The agency plays the critical role of deciding which products are safe for use in the country — everything from medications to medical devices to vaccines.