Crawford Reportedly Did Not Cooperate With GAO Plan B Investigation

Former FDA Commissioner Lester Crawford did not respond to requests for an interview by Government Accountability Office staff investigating the agency's 2004 rejection of Barr Pharmaceuticals' application to allow nonprescription sales for the emergency contraceptive Plan B, according to congressional staffers who have read GAO's draft report on the investigation, the Washington Post reports (Kaufman, Washington Post, 10/14).

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 and 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. 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 (California Healthline, 10/13).

The rejection was discussed at a January 2004 staff meeting when Mark McClellan -- now Centers for Medicare and Medicaid Services administrator -- was commissioner of FDA. It is unclear if McClellan spoke with GAO, the Post reports. Crawford served as deputy FDA commissioner and acting commissioner during the period investigated by GAO.

Both FDA and GAO spokesperson Paul Anderson declined to comment on the contents of the draft report, according to the Post. Anderson noted that GAO can demand documents from federal agencies but cannot force an official to speak with investigators.

Sen. Patty Murray (D-Wash.) on Thursday said she is "very disturbed" by the draft report and Crawford's refusal to be interviewed, adding, "Refusing to explain his role in this decision is not acceptable." Sen. Hillary Rodham Clinton (D-N.Y.) in a statement said, "The draft GAO report appears to confirm what we have suspected for some time: Science was compromised in the FDA's decision-making process on Plan B" (Washington Post, 10/14).

Rodham Clinton and Murray earlier this year put a hold on Crawford's nomination to be FDA commissioner because the agency in January delayed making a decision on Barr's revised application for nonprescription Plan B (California Healthline, 9/6).

Crawford, who Congress approved to head FDA in July, resigned from his position late last month. In August, he announced that the agency would indefinitely defer Barr's most recent application for Plan B and opened a 60-day public comment period on the 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, 10/13). FDA has until Oct. 26 to comment on the GAO report, which is scheduled to be released to the public next month (Washington Post, 10/14).