McClellan Confirmation as FDA Commissioner Expected Before Senate Recess

Dr. Mark McClellan, President Bush's nominee for FDA commissioner, yesterday "breezed through" a confirmation hearing before the Senate Health, Education, Labor and Pensions Committee, the Washington Post reports (Kaufman, Washington Post, 10/8). During the hearing, committee Chair Edward Kennedy (D-Mass.) announced his support for McClellan and said that the committee would vote as early as Wednesday on his confirmation. Kennedy added that he hoped the Senate would confirm McClellan before lawmakers adjourn at the end of next week (Stolberg, New York Times, 10/8). McClellan, a physician with a doctorate in medical economics, has served as a White House health policy adviser and as a member of the Council of Economic Advisers in the Bush administration. He has represented the Bush administration in negotiations with Congress on a Medicare prescription drug benefit and proposals to extend health coverage to the uninsured. 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. McClellan practiced as a physician at Stanford University, where he also taught health care economics, before he joined the Bush administration (California Healthline, 9/25).

During the hearing, McClellan did not outline "specific positions" that he would take on issues as FDA commissioner, but he offered "themes" that the Wall Street Journal reports the pharmaceutical industry would likely support (Adams, Wall Street Journal, 10/8). For example, McClellan said that he would work with FDA staff to speed the approval process for new prescription drugs, adding that he does not "think there needs to be a conflict between stressing safety concerns and handling them appropriately, and approving drugs quickly." McClellan also said that he supports expanding a program under which the FDA charges pharmaceutical companies a fee in exchange for an expedited review of new treatments to other products, such as medical devices and veterinary medications, the Post reports (Washington Post, 10/8). He added that he favors the use of outside consultants to review new medical devices (Cohen, Newark Star-Ledger, 10/8). In addition, McClellan said that he would not address whether the FDA should regulate tobacco products, and he said that direct-to-consumer advertising of prescription drugs helps promote "treatment of conditions that are seriously undertreated." Although the hearing "seemed to clear the way" for McClellan's confirmation, the Times reports that he "disappointed" some consumer advocates. Diana Zuckerman, president of the National Center for Policy Research for Women and Families, said, "He didn't make any commitment to strengthen the authority of the FDA" (New York Times, 10/8).

Former Senate staffer Doug Badger will replace McClellan as White House health policy adviser, the White House confirmed last week, CongressDaily reports. Badger, a Washington Council Ernst & Young lobbyist, in the past has served as chief of staff to Sen. Don Nickles (R-Okla.). "Mr. Badger has almost two decades of policy experience, particularly involving health care issues," the White House said in a statement (CongressDaily, 10/7).