FDA turns down OTC status for emergency contraception

When the Food and Drug Administration took the unusual step in May of going against the advice of two of its expert committees by denying Plan B emergency contraception's over-the-counter status, reproductive health advocates cried foul but others exhaled with relief.

The same people who cheered in December 2003 when the advisory committees voted 24-4 in favor of the switch suggested that politics were superseding science.

"I hold the FDA indirectly responsible for the hundreds if not thousands of unintended pregnancies with their consequences," said David Grimes, MD, vice president of biomedical affairs for Family Health International, a nonprofit organization supporting abortion rights located in Research Triangle Park, N.C. He spoke in favor of the switch at the FDA hearing.

Opponents, though, anti-abortion activists as well as those who argued emergency contraception should only be available as it is now -- with physician advice -- applauded the decision, saying it took into account unknowns about whether availability without doctor involvement could be detrimental to women's health, particularly that of younger women.

"There are concerns sufficient enough for them to wait and get more information," said Gene Rudd, MD, associate executive director of the Christian Medical Assn. "I don't think the FDA is kowtowing to political pressure. I think they're doing their job."

The door to this product's OTC status, however, is not completely closed. The FDA asked Barr Pharmaceuticals Inc., the manufacturer, to either provide data about whether adolescent women can effectively use it or apply for it to be made available over the counter to those older than 16 and by prescription for those younger.

"Although we did not have sufficient data to approve this application now, I will be working toward the expeditious evaluation of Barr's response to the Not Approvable letter," said Steven Galson, MD, acting director of FDA's Center for Drug Evaluation and Research.

Few on either side of the issue are particularly happy with the possible compromise. Some say the age restriction does not address the potential for misuse.

"It's better than not having any age limits, but I would feel more comfortable if the patient talked to someone who was knowledgeable in health care," said M. LeRoy Sprang, MD, associate professor of obstetrics and gynecology at Northwestern University Feinberg School of Medicine, Chicago.

OTC supporters doubt that the compromise plan is workable.

"I don't think it's going to work," said Valerie Montgomery Rice, MD, an advisory committee member who voted in favor of the switch. She is chair of ob-gyn department at Meharry Medical College in Nashville. "But at least we'll have the opportunity to make it more available to some women."

There are also questions about the feasibility of the studies that the FDA requested.

"There is no scientific data to support concerns," said Melanie A. Gold, DO, associate professor in pediatrics and adolescent medicine at the University of Pittsburgh School of Medicine. She authored a study in the April Journal of Pediatric and Adolescent Gynecology concluding that sexual activity of minors who are provided access to Plan B through advance prescriptions did not increase.

"These are hard and expensive studies to do because it's really challenging to recruit sexually active kids, and it's really unreasonable for a medication that is safe," she said.

Meanwhile, the questions swirling around why the agency did what it did prompted a coalition of House of Representatives members who support abortion rights to demand a General Accounting Office investigation.

"The panel meeting was so well done and the votes were so overwhelming that one would have assumed that it was a slam dunk," said Linda Suydam, DPA, president of the Consumer Healthcare Products Assn., the trade association for over-the-counter medications. "My concern is with the integrity of the process. One would expect that, as much as possible, that it would be an open and transparent process. This was not open."

The FDA is not bound by the recommendations of its advisory committees and has on rare occasions gone against their wishes.