Bush Nominates Health Policy Adviser McClellan as FDA Commissioner
As expected, President Bush yesterday nominated Dr. Mark McClellan, a senior White House health policy adviser, to serve as commissioner of the FDA, the Houston Chronicle reports (Mason, Houston Chronicle, 9/25). Analysts had predicted McClellan's nomination for several months but did not expect Bush to make an official announcement until the end of the congressional session because of McClellan's "high profile" in Congress. McClellan represents the Bush administration on several "hot-button" health care issues, such as a Medicare prescription drug benefit and a Medicare "giveback" bill for providers. White House spokesperson Scott McClellan, the nominee's brother, said that Mark McClellan will "continue in his current role" during the confirmation process. A spokesperson for Sen. Edward Kennedy (D-Mass.), chair of the Senate Health, Labor, Education and Pensions Committee, said that Kennedy "does not anticipate a problem with McClellan's continuing to broker on behalf of the administration." Although analysts expect the Senate to approve McClellan's nomination, the Kennedy spokesperson said that he likely will not receive confirmation before the end of the congressional session (Rovner, CongressDaily, 9/25).
As FDA commissioner, McClellan would face a number of "key issues," the Wall Street Journal reports. For example, the pharmaceutical industry and patient advocacy groups have asked for more expedited reviews of new treatments, as consumer advocates lobby for a "more cautious approach." McClellan also would "step directly into a thorny free-speech issue," the Journal reports. The FDA has begun to review restrictions on commercial speech in areas such as television advertisements for prescription drugs and food labels (Adams, Wall Street Journal, 9/26). Although McClellan's nomination has "elicited positive comments" from industries that the FDA regulates, consumer advocacy group Public Citizen has questioned his management and scientific experience. Peter Lurie, deputy director of the Health Research Group at Public Citizen, said that McClellan has expertise in the use of medical treatments, an area "not directly relevant to the FDA's responsibilities" (Rubin, USA Today, 9/26).
Although Mark McClellan, President Bush's FDA commissioner nominee, appears to be "the sort of able and relatively nonpartisan policy wonk the FDA needs," the Senate should use his confirmation hearing to "let him know that ... the agency needs a leader willing" to make changes, a Los Angeles Times editorial says. The Times recommends that the new FDA chief change the agency so that it can quickly approve "genuinely promising new drugs ... without further demoralizing the agency" by creating a "sweatshop environment." The new FDA head also needs to address the agriculture industry's "indiscriminate use" of antibiotics as growth promoters because of its contribution to the growing resistance of antibiotics in humans. In addition, the FDA chief should help "fix" the problem of childhood vaccine shortages by "expedit[ing] the review" of such vaccines. The Times concludes that the FDA needs "a leader able to produce bold change" (Los Angeles Times, 9/26).
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