 |
 |
Produced for LMC-TVbyFran Snedeker |
|
|
Produced for LMC-TVbyFran Snedeker |
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
(Kaiser
Daily Women's Health Policy Report, 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 (Kaiser Daily Women's Health Policy Report, 9/26).
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. At least two people have resigned from their positions with FDA in protest of the Plan B decision. Frank Davidoff, a consultant and former member of FDA's Nonprescription Drugs Advisory Committee, resigned in September, and Susan Wood resigned from her position as FDA assistant commissioner for women's health in late August (Kaiser Daily Women's Health Policy Report, 10/14). 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).
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=33102