Former FDA assistant commissioner visits U, discusses Plan B controversy

Faith Holschbach

Susan Wood resigned from the Food and Drug Administration as assistant commissioner for women’s health in 2005 because of the agency’s reluctance to approve Plan B, a form of emergency contraception, for over-the-counter availability.

She spoke Monday about her decision and the surrounding controversy at the 3rd Annual Women’s Health Research Conference at McNamara Alumni Center, sponsored by the University’s National Center of Excellence in Women’s Health.

The event drew students, faculty and staff members and medical professionals.

Becky Gams, clinical coordinator at the University’s Deborah E. Powell Center for Women’s Health, staffed the event.

“Three hundred and twenty people are registered, but at least 50 have walked in,” she said.

The event featured speakers on topics such as “Protecting the Reproductive Health of Adolescents” and “Ethical Issues in Medical Genetics.” Wood’s keynote address was on “Women’s Health, Emergency Contraception and the FDA.”

Wood, who has a doctorate in biology, explained that the proposal to make Plan B available over the counter first came to the FDA in December 2003.

The proposal passed every level of advisory committees but stalled at the highest level of the agency.

Wood said she thought science supported the drug and it was safe, and that she did not understand why the FDA did not promptly approve Plan B for over the counter use.

“I resigned when I knew I could not defend that decision,” Wood said.

Wood said approval was announced just a day before the confirmation hearing of the FDA Commissioner Andrew von Eschenbach and that there was no new information to influence this decision.

While Wood didn’t explicitly name politics or religion as the reason for the delay, she showed a political cartoon to that effect and called for an independent FDA.

“We need to have an independent FDA because we depend on it for so many things,” Woods said, citing that 25 cents of every dollar U.S. consumers spend falls under FDA jurisdiction be it for food, cosmetics, medicine or any other product the agency regulates.

Wood, who has spoken in more than 40 cities since resigning, said she thinks the most important message for someone to take is “the critical importance of good science driving our policy.”

Amit Goyal, a biology junior, said he felt Wood was telling the truth about politics influencing the decision.

“When the science is supportive the FDA should make the (supported) decision,” Goyal said.

Wood said much of the controversy surrounding Plan B is the confusion about its actual use. Plan B is not an abortive pill; it will not harm an existing pregnancy, she said.

“The only connection it has to abortion is that it will prevent a need for one,” she said.

Even though Plan B is approved for over-the-counter use by women older than 17, it might not appear on drugstore shelves until 2007.

Barr Pharmaceuticals manufactures Plan B. Carol Cox, vice president of investor relations and corporate communications, explained the delay in an e-mail.

“This new product requires a dual label, new packaging and additional patient materials as a result of its new status (as an over-the-counter drug),” Cox said. “The company is currently preparing for a launch that will be no later than the end of calendar 2006 and hopefully sooner.”