Bush To Nominate White House Health Adviser McClellan as FDA Commissioner

President Bush plans to nominate Mark McClellan, a senior White House health policy adviser, to serve as commissioner of the FDA, according to administration officials, the New York Times reports (Gay Stolberg, New York Times, 9/25). An unnamed administration official said that the nomination "announcement is expected soon," and congressional sources said that "it could come as early as today," the Washington Post reports (Kaufman, Washington Post, 9/25). McClellan, a physician with a doctorate in medical economics, has helped develop Bush's Medicare reform and prescription drug benefit proposals (Chen, Los Angeles Times, 9/25). McClellan earlier this month participated in negotiations between the White House and Congress over a Medicare prescription drug benefit and increases in reimbursements to Medicare providers, delaying his nomination (California Healthline, 9/12). McClellan, a native of Austin, Texas, graduated from the University of Texas with degrees in English and biology. He earned his medical degree from Harvard Medical School and received an economics degree from the Massachusetts Institute of Technology (Schatz, Austin American-Statesman, 9/25). McClellan practiced as a physician at Stanford University, where he also taught health care economics, before he joined the administration. McClellan will likely "easily" win confirmation as FDA commissioner, the Los Angeles Times reports (Los Angeles Times, 9/25). The Senate has confirmed him as a member of the President's Council of Economic Advisers, and Republicans on the Senate Health, Education, Labor and Pensions Committee, which would consider his nomination as FDA commissioner, earlier this month predicted no problems with confirmation (American Health Line, 9/12).

McClellan's nomination would end a "tumultuous" 20-month search for an FDA commissioner (Kranish, Boston Globe, 9/25). The Los Angeles Times reports that the "unyielding opposition" of Senate HELP Committee Chair Edward Kennedy (D-Mass.) to nominees with industry ties contributed to the delay (Los Angeles Times, 9/25). Bush in February planned to nominate Dr. Alastair Wood, a prescription drug safety expert at Vanderbilt University, but pharmaceutical companies raised concerns that Wood would take an "aggressive" position against the industry. At that time, Bush named Dr. Lester Crawford, deputy commissioner of the FDA, as interim commissioner. Although HHS Secretary Tommy Thompson supported Crawford, a veterinarian and food safety expert, to serve as FDA commissioner, the "White House was said to want a physician" for the position, the New York Times reports. The delay had raised concerns from lawmakers, as well as representatives from industry and consumer groups, who said that the FDA "needed a leader" (New York Times, 9/25). The pharmaceutical industry "complained vehemently" that the vacancy delayed approval times for new treatments (Boston Globe, 9/25).