Several members of the Food and Drug Administration’s (FDA) expert advisory committees are speaking out against the agency’s delay of its decision to make the emergency contraceptive Plan B available without a prescription. Two doctors on the advisory committee and Jeffrey M. Drazen, MD, the editor of New England Journal of Medicine, published an opinion piece in this week’s issue of the journal charging that the postponement of the FDA’s decision on making EC available over-the-counter “suggests that the FDA’s decision-making process is being influenced by political considerations.”
The doctors further argue that “treatment for any other condition, from hangnail to headache to heart disease, with a similar record of safety and efficacy would be approved quickly. Why has the FDA adopted its own plan B with respect to approval for over-the-counter use, instead of going ahead with the recommended approval?”
An overwhelming 23 out of the 27 FDA Reproductive Health Drugs and Nonprescription Advisory Committee members agreed that Emergency Contraception is safe, effective and meets all the requirements for over-the-counter status. Despite the recommendations of these expert medical committees made in December 2003, the FDA announced that it would delay its Feb. 20 decision on the status of the emergency contraceptive Plan B by 90 days.
Meanwhile, Barr Laboratories, the distributor of Plan B, and the FDA have been working on a compromise that would greatly restrict the accessibility of EC. According to the Washington Post, the compromise could include setting a minimum age to buy Plan B and keeping the drug behind-the-counter so that pharmacists can control sales.
Emergency contraception is safe, and most effective if taken within 24 hours after unprotected intercourse, contraceptive failure, or rape. “To deny women unrestricted over-the-counter access is simply unacceptable from a feminist and public health standpoint. Responsible women seeking to avoid an unintended pregnancy must be able to access this drug quickly. Access delayed is access denied,” said Feminist Majority Foundation Medical Director Beth Jordan, MD