FDA Decision on Application for Emergency Contraceptive Plan B Unusual, GAO Draft Report Finds
FDA's 2004 rejection of Barr Pharmaceuticals' application to allow nonprescription sales for the emergency contraceptive Plan B was an atypical decision made with uncharacteristic involvement from leading agency officials and might have been decided several months prior to its formal announcement, according to a draft report from the Government Accountability Office released Wednesday to some congressional staffers, the Washington Post reports (Kaufman, Washington Post, 10/13).
FDA in May 2004 issued a "not approvable" letter in response to Barr's original application to allow Plan B to be sold without a doctor's prescription, citing inadequate data on Plan B use among girls under age 16. The agency's 2004 decision was unusual because it contradicted the recommendations of two FDA advisory panels, which in December 2003 voted 23-4 to recommend that Plan B be sold without a prescription.
In addition, the letter was unusual in that it was signed only by Steven Galson, then-acting director of FDA's Center for Drug Evaluation and Research, and not by members of the FDA review team, as is routine. Galson later acknowledged that he made the decision to reject the application on his own and did not follow the recommendations of his staff (California Healthline, 5/13/04).
However, the GAO report found that the decision to reject the application involved other top agency officials and was made months before the official announcement, the Post reports. The report says that "such unusual high-level involvement was justified by the perceived sensitivity of the issue," the Post reports.
Critics of the decision have accused the agency of giving in to political pressure from conservatives who opposed the application, according to the Post. The draft report, which was requested by Congress in the summer of 2004, is scheduled to be finalized and released to the public by the end of the month (Washington Post, 10/13).
Former FDA Commissioner Lester Crawford, who resigned from his position last month, in August announced that the agency would indefinitely defer Barr's most recent application for nonprescription sales of Plan B and opened a 60-day public comment period on the application. FDA in January delayed a ruling on Barr's revised application, which would allow Plan B to be sold without a doctor's prescription only to women ages 17 and older.
Crawford said that science supports giving nonprescription access to Plan B to women ages 17 and older but added that the application presented FDA "with many difficult and novel policy and regulatory issues," including how to keep girls age 16 and younger from obtaining the drug. Susan Wood resigned from her position as FDA assistant commissioner for women's health in late August in protest of the Plan B decision (California Healthline, 9/21).
NPR's "All Things Considered" on Wednesday reported on recent events at FDA that could affect the agency's credibility, including its delay of a decision on Plan B. The complete segment is available online in RealPlayer.