FDA Panel Backs Easier Access to Morning-After Pill

On Tuesday, an advisory panel of the Food and Drug Administration voted 23-4 to recommend allowing the Plan B "morning after" contraceptive to be sold without a prescription.

The medication is intended for use by women within 72 hours of intercourse. Plan B is made by Women's Capital Corp., a privately held company that is in the process of selling the drug to Barr Laboratories Inc. The vote was preceded by testimony from the manufacturer, FDA staff members and members of the public.

"We need to decrease the barriers" so women can access the product in time for it to work, said panel member Dr. Abby Berenson, chief of pediatric and adolescent gynecology at the University of Texas Medical Branch-Galveston. The pills should be available over the counter, supporters said, to give women a second chance to avoid pregnancy after unprotected sex, rape, or when a condom breaks.

But opponents argued that women relying on Plan B would abandon other contraceptives. If women do not use condoms, they said, women will put themselves at risk of STDs. "Over-the-counter availability of the morning-after pill will lead to increased promiscuity and its attendant physical and psychological damage," testified Robert Carroll, a retired Pittsburgh physician. Others rejected Plan B as the equivalent of abortion.

The treatment involves two tablets taken 12 hours apart. Members of the advisory panel said Plan B's instructions should say it is a backup method and not a substitute for regular birth control. FDA staffers said Plan B's risks are "very limited" and posed no clear danger to a fetus if a woman was already pregnant.

Feb. 20 is the deadline for FDA to rule on Plan B, Barr said. FDA usually follows the advice of its advisory panels.

Back to other news for December 17, 2003