Anger over the U.S. rejection of over-the-counter sales of a “morning-after” pill simmered in Congress on Wednesday as 41 lawmakers urged regulators to immediately reconsider the decision.
Critics charged the U.S. Food and Drug Administration with putting politics before science in denying Barr Pharmaceuticals Inc.‘s bid to sell its emergency contraceptive, Plan B, without a prescription.
Rep. Louise Slaughter called for the resignation of acting FDA Commissioner Lester Crawford and Dr. Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research.
“It is appalling that a nation with one of the highest teen pregnancy rates in the industrialized world would deny women this safe contraceptive option,” said Slaughter, a New York Democrat.
Slaughter also asked the non-partisan General Accounting Office “to investigate the serious allegations that the FDA allowed political considerations to affect its decision.”
Peter Pitts, FDA associate commissioner for external relations, said the agency stood by its decision but would consider any new application from Barr.
“We presented to Barr a bright path forward to approval,” he said.
FDA officials are willing to meet with Slaughter and other lawmakers to discuss the matter, Pitts said.
Plan B is an emergency contraceptive that can prevent pregnancy if taken within 72 hours after sexual intercourse.
Women’s groups and other supporters of switching Plan B from a prescription to over-the-counter drug argue that wider access would decrease abortions.
Opponents, including conservative groups and lawmakers, said easy access would lead to more promiscuity and sexually transmitted diseases, particularly among teenagers.
An outside advisory panel had recommended approval by a 23-4 vote, and FDA staff scientists also supported an over-the-counter switch.
Galson said last week he decided to reject Barr’s application because there were not enough data on use of the pills by girls under 16. He said politics played no role in the decision.
Forty-one House members, most of them Democrats, sent a letter to Crawford urging the agency to quickly rethink the matter.
“This decision ignores the significant need for access to emergency contraception, including by young women,” the letter said.
Revision date: July 5, 2011
Last revised: by Sebastian Scheller, MD, ScD