FDA Slammed on Contraceptive Case

Drug Policy

The FDA decision to not approve the emergency contraceptive Plan B for over-the-counter sales was unusual, according to a lengthy investigation by the Government Accountability Office.

In a blunt assessment, GAO reports that FDA did not follow its normal practices in several ways, including unusual involvement by high agency officials in the 2004 decision. The report also hints that the decision to reject the switch from prescription to over-the-counter (OTC) status might have been made before all of the agencys reviews were completed. This suggestion has been denied by Stephen Galson, then-acting director of FDAs Center for Drug Evaluation & Research, who signed the letter saying the switch was not approvable.

GAO points out that Plan B is the only product out of 67 proposed prescription-to-OTC switch applications between 1994 and 2004 that was not approved after FDA advisory committees okayed the switch.

Because the product is a contraceptive, even the possibility that conservative ideology may have been a factor in the decision has raised serious concerns in Congress. Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.), who were among the 48 members of Congress who requested the GAO investigation, are convinced of political interference. The long-awaited report leaves no question that science was compromised in the FDAs decision-making process on Plan B, the two senators said in a statement.

The products manufacturer, Barr Pharmaceuticals, has submitted additional data to FDA since the disapproval. Despite promises to Congress that a new decision would be made before Sept. 1, FDA has not announced its decision.