After a long delay, President George W. Bush nominated Dr. Mark McClellan, a senior White House health policy advisor, to serve as commissioner of the Food and Drug Administration (FDA).
Currently, McClellan is a member of the White House Council of Economic Advisors. Before joining the Bush administration, he was an associate professor of both economics and medicine at Stanford University. McClellan has a degree in medicine from Harvard Medical School and a Ph.D. in economics from MIT.
McClellan has represented the Bush administration on several controversial health care issues, including Medicare prescription drug benefit proposals and the “giveback” bill for health care providers.
As FDA commissioner, McClellan would face a number of major issues. For example, the pharmaceutical industry and patient advocacy groups have asked for more expedited reviews of new drug-based treatments, as consumer advocates lobby for a more cautious approach.
McClellan also would step into a thorny free-speech issue. The FDA has begun to review restrictions on commercial speech in areas such as television advertisements for prescription drugs and food labels.
Support Is There
White House spokesperson Scott McClellan, the nominee’s brother, said Mark McClellan would continue in his current role at the Council of Economic Advisors during the confirmation process. Although analysts expect the Senate to approve McClellan’s nomination, it is unlikely he would receive confirmation before the end of the congressional session.
McClellan’s primary expertise is in the economics of health care. Some industry spokesmen welcomed his nomination. “We are pleased that the Bush administration has made a selection to fill this critical position, and from Dr. McClellan’s educational background and experience in medicine, health care, and economic policy, he appears to be an excellent candidate,” Biotechnology Industry Organization President Carl B. Feldbaum said.
The Pharmaceutical Research & Manufacturers of America (PhRMA) expressed pleasure that the White House had finally selected a candidate, but also said it needs to learn more about McClellan and his career before commenting on his suitability for the position.
Although McClellan’s nomination has received positive nods from industries regulated by the FDA, consumer advocacy groups like Public Citizen have questioned his management and scientific experience.
Peter Lurie, deputy director of the Health Research Group at Public Citizen, told USA Today McClellan has expertise in the use of medical treatments, an area “not directly relevant to the FDA’s responsibilities.”
Grace-Marie Turner, president of The Galen Institute, disagreed with Lurie’s take on the nominee. “There aren’t enough superlatives to describe how invaluable Mark has been to shaping the Bush administration’s free-market agenda during less than 20 months as the President’s chief health policy advisor and member of his Council of Economic Advisors,” she said.
Turner also noted the evidence indicates McClellan quickly masters any task he tackles. “Mark put into policy language the President’s broad vision of a patient-centered health system that combines high quality with universal accessibility. His prior research into the value and costs of new technologies will be particularly relevant at the FDA,” she said.
An article in The Washington Post quoted Sen. Edward Kennedy (D-Massachusetts), chair of the Senate Health, Labor, Education and Pensions Committee, as saying McClellan has “impressive credentials both as a physician and as an economist.” Senator Judd Gregg (R-New Hampshire) called McClellan “a thoughtful and conscientious choice.”
In related news, Health and Human Services (HHS) Assistant Secretary for Planning and Evaluation Bobby Jindal has emerged as the leading candidate to replace McClellan at the Council of Economic Advisors.
In his position at HHS, Jindal has worked with the White House on health care legislation, strategic planning, and regulatory reviews. In the past, Jindal served as secretary of the Louisiana Department of Health and Hospitals and as executive director of a 1998-99 federal advisory commission that recommended broad Medicare reforms.
Conrad F. Meier is managing editor of Health Care News.