Permanent Commissioner Pick Called For By Senate Health Committee
This article was originally published in The Tan Sheet
Executive Summary
President Bush needs to nominate a permanent FDA commissioner "as soon as possible," members of the Senate Health, Education, Labor & Pensions Committee urge in a Feb. 1 letter
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President Bush needs to nominate a permanent FDA commissioner "as soon as possible," members of the Senate Health, Education, Labor & Pensions Committee urge in a Feb. 1 letter. "An Acting Commissioner, regardless of his or her qualifications and accomplishments, simply lacks the mandate for action that comes only through the constitutional process that includes the Commissioner's nomination by the President and subsequent confirmation by the Senate," the letter says. FDA is at "a crucial juncture in its history," the senators state. The letter cites the current environment of congressional and public scrutiny of drug safety and approval issues. "At the same time, advances in genetics, pharmacology and related fields soon will challenge our conventional regulatory approaches," the members add. As a result, FDA "needs a leader with the vision to guide the agency through this critical period and maintain the public's confidence in its work," the senators conclude. The letter is signed by committee Chair Michael Enzi (R-Wyo.), Ranking Member Edward Kennedy (D-Mass.) and most members of the committee. The lawmakers promise to hold a hearing "expeditiously" upon the President's nomination. Lester Crawford, PhD, has led the agency as Acting Commissioner since Mark McClellan, MD/PhD, left to head the Centers for Medicare & Medicaid Services. Crawford is understood to be the Administration's choice to fill the permanent role following a Jan. 27 meeting with President Bush (1 (Also see "FDA Pick Appears To Be Crawford; HHS Secretary Leavitt Takes Office" - Pink Sheet, 31 Jan, 2005.), p. 3). The HELP Committee letter maintains a permanent commissioner is needed to support HHS Secretary Michael Leavitt, who was unanimously approved by the panel. "So that Secretary Leavitt can do his job most effectively, you and he need to identify a nominee for FDA commissioner who has demonstrated leadership capabilities, a strong knowledge of science and an unwavering commitment to promoting and protecting the public health," the HELP members state. Leavitt has indicated that the White House will handle the process of selecting a nominee. He said during the confirmation process that he expected the Administration to name a nominee shortly. The Administration is reportedly considering a drug-safety initiative that would be announced in the near future. There may be plans to pair the commissioner pick and the safety program announcements together. Leavitt outlined a cautious approach to evaluating the state of drug safety at FDA in response to written questions from Finance Committee Chair Charles Grassley (R-Iowa). Regarding the necessity of making the drug safety office independent from CDER, as advocated by Grassley, Leavitt stressed that the Office of Drug Safety "is already an independent office separate from the Office of New Drugs." "I believe we should move carefully before undertaking any restructuring," the secretary said. Leavitt maintained FDA's drug review "is a gold standard" in response to an inquiry from Grassley about the agency's ability to assess drug safety. The question was asked in light of recent issues surrounding the COX-2 inhibitors and antidepressants. The secretary refers to the Institute of Medicine study of the drug safety system and other efforts undertaken by FDA to strengthen the system (2 (Also see "FDA Drug Safety Process Subject To IoM Review Under Agency Initiative" - Pink Sheet, 8 Nov, 2004.), p. 3). "I look forward to reviewing the results of this study and to working with the FDA and the Congress to further improve the ability of the FDA to monitor and respond to drug safety issues," Leavitt said. |