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Produced for LMC-TVbyFran Snedeker |
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Produced for LMC-TVbyFran Snedeker |
Eighteen Democratic House members on Monday (November 14, 2005) sent a letter to HHS Secretary Mike Leavitt questioning former FDA Commissioner Mark McClellan's role in the agency's 2004 decision to reject Barr Laboratories' original application to allow nonprescription sales of the emergency contraceptive Plan B, CQ HealthBeat reports (CQ HealthBeat, 11/15). The letter followed the release of a Government Accountability Office report on Monday that concluded that FDA's rejection of Barr's application was "unusual" and "not typical" of FDA's regular review process. According to the report, high-level officials at FDA told some staff members as early as January 2004 that the agency would reject the application even though the scientific review was not completed until April 2004. The report also found conflicting reports about whether McClellan instructed officials to reject the application after a December 2003 meeting. McClellan in a written document to investigators said his involvement in Barr's application was typical and that the decision was made after he left FDA (Kaiser Daily Women's Health Policy Report, 11/15). However, the lawmakers in the letter said McClellan's role in the decision remains "unclear" and that McClellan "himself did not cooperate with GAO's investigation." The letter called on Leavitt to provide an explanation as to why FDA was "unable to provide for GAO investigators any communications to or from the office" of McClellan, who is now chief administrator of CMS. The lawmakers said the FDA commissioner's office could not provide such documents because it said it "deleted e-mails daily and ... did not retain written correspondence, including memos," practices that raise "serious questions about the agency's compliance with federal records management law." The lawmakers said that the GAO report's conclusion that a decision to reject the application appeared to be "preordained from the outset" shows "an agency that placed political considerations ahead of its obligation to evaluate drugs based on the scientific evidence" (Waxman et al. letter, 11/14).
Waxman Letter
Rep. Henry Waxman (D-Calif.) in a separate letter to the House Committee on Government Reform Chair Tom Davis (R-Va.) urged the committee to investigate FDA's decision to indefinitely delay a decision on nonprescription sales of Plan B, calling the decision "an egregious example of the politicization of science." Waxman said the GAO report "did not examine" whether officials at HHS or the White House played any role in this "apparent subversion of science," and he asked Davis to join him in requesting from FDA, HHS and the White House documents regarding Plan B, including communications, written or electronic, and records of phone conversations and meetings between FDA and other HHS officials (Waxman letter, 11/15).
WBUR's "On Point" on 11/16/05 in the first hour of the program was scheduled to include a discussion of the GAO report on Plan B. Guests on the program are to include Marc Kaufman, national health reporter for the Washington Post; Chris Mooney, Washington correspondent for Seed Magazine and author of "The Republican War on Science;" and Susan Wood, who resigned from her position as FDA assistant commissioner for women's health earlier this year because of the agency's handling of the issue (Ashbrook, "On Point," WBUR, 11/16). The complete segment will be available online in RealPlayer and Windows Media after the broadcast.