Bulletin: FDA delays decision on Plan B

The decision to move the levonorgestrel emergency contraceptive pill Plan B (Barr Laboratories, Pomona, NY) to over-the-counter status (OTC) has been delayed by the Food and Drug Administration (FDA).

The agency announced Feb. 13, 2004, that it was extending its review of the company’s request, which allows it to analyze additional data on adolescent use submitted by Barr Labs and Plan B’s former owner, Women’s Capital Corp. of Washington, DC. Based on its ongoing dialogue with the FDA, Barr Laboratories says it expects a decision regarding the OTC status within 90 days of the original Feb. 20, 2004, review deadline.

Two FDA advisory committees voted 23-4 in December 2003 that the agency approves the company’s request, based on the strength of the scientific evidence presented at the meeting.

Barr Laboratories will continue to work closely with the FDA to assist in the timely completion of the review, according to a statement issued by the company.

"We believe that availability of the Plan B emergency contraceptive as an OTC product meets a significant unmet medical need, and that OTC status will remove barriers that currently delay the timely availability of Plan B for women who have had unprotected sexual intercourse or experienced a contraceptive failure," states Bruce Downey, Barr’s chairman and chief executive officer.

The fact that the FDA has postponed the decision raises concern that the decision could be affected by ideology, observes James Trussell, PhD, professor of economics and public affairs and director of the Office of Population Research at Princeton (NJ) University. He was a member of one of the FDA committees that voted in favor of the OTC proposal.

"I had expected, after the very positive reviews by FDA staff presented at the advisory committee meeting and the overwhelmingly positive 23-4 vote to take Plan B over-the-counter and the extraordinarily positive editorial coverage across the country urging the FDA to base its decision on science and not ideology, that the FDA would approve the application by the Feb. 20 deadline," says Trussell. "The advisory committee vote was to take Plan B OTC with no age restrictions."