FDA turns down OTC status for emergency contraception

The agency rejects an application for broader access to Plan B, despite the recommendations of its advisory panels.

By Victoria Stagg Elliott, AMNews staff. June 7, 2004.

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.