Former FDA official says politics trumps science

If the U.S. Food and Drug Administration (FDA) can be swayed by political pressure rather than scientific evidence, is public health in danger?

That’s the question that Susan Wood, then FDA assistant commissioner for women’s health and director of its Office of Women’s Health, asked her employer shortly before she quit last August, after the agency held up approval of the emergency contraceptive pill Plan B, known as the “morning-after” pill, as an over-the-counter-drug, for reasons that Wood believes were primarily political.

As keynote speaker of the annual Women in Medical Sciences luncheon, held at the School of Medicine on March 6, Wood (CAS’89) outlined the way drugs are normally reviewed and approved or not approved by the FDA and talked about how the process was corrupted in the case of Plan B.

At first, said Wood, the FDA review of Plan , which has been approved for sale with a physician’s prescription, was relatively free of controversy, and the drug was unanimously approved for safety by two review committees. Yet when it came time to issue a decision, she said, twice high-level members of the FDA who don’t normally take part in the regulatory process stepped in.

The first application was for approval to make Plan B available over the counter. That plan, she said, was rejected because a study of label comprehension did not include enough young teens. The second application sought to allow the pill to be available over the counter to anyone over the age of 17, and by prescription only to anyone younger. Wood said FDA officials deemed that two-tiered plan so complicated that it would require new regulations, even though other drugs have two-tiered plans without the special rules. Wood acknowledged that rule-making is sometimes necessary, but pointed out that at the FDA it is often a process that takes years. “To throw an application into rule-making,” she said, “is to throw it into a black hole.”

“What is so scary about contraception for adults that makes it necessary to hijack the entire FDA and disregard the opinions of its professional staff?” she asked.

Wood suspects that approval of Plan B was denied in part because of pressure from anti-abortion groups, who harbor a misconception that the drug can cause abortions. “Its only relation to abortion,” she said, “is that it can prevent the need for one.”

Plan B is a contraceptive. “It is not RU-486,” Wood said. “Contraception is widely used across this country. It’s not controversial.”

She also believes that pressure came from activists who wrongly fear that contraception encourages promiscuity. Years of studies have shown, she said, that making contraception available does not influence people to change their behavior and become more promiscuous; the behavior it changes is that people will use contraceptives if it is easy to obtain.

The fate of Plan B led Wood to question whether the FDA could be trusted with its mission of protecting public health. She began to wonder if the agency would make similar moves to block the approval of a vaccination against HPV (human papilloma virus), a sexually transmitted disease that can cause cervical cancer, or an AIDS vaccine.

Wood told the audience that she could not be sure the answer would be no. And, she said, she has heard no recent assurances from Andrew C. von Eschenbach, the new acting director of the FDA.

Karen Freund, a MED professor of medicine and chief of the Women’s Health Unit at Boston Medical Center, shares Wood’s concern.

“If the FDA isn’t basing their decisions largely on scientific evidence,” she said, “then it’s not just a contraception issue, an abortion issue, or a women’s health issue. It’s a public health issue.”

The Women in Medical Sciences series, sponsored by the BU Medical Center, the Center of Excellence in Women’s Health, and the Women’s Health Interdisciplinary Research Center, was initiated to bring prominent speakers to Boston Medical Center and provide a forum for junior faculty and postdocs to meet with senior-level women in the medical community and discuss common areas of interest related to clinical and research work.