Mark McClellan

After graduating from the University of Texas in 1985 majoring in English, Biology, and Plan II, he earned his M.D. degree from the Harvard–MIT Division of Health Sciences and Technology in 1992 and his Ph.D. in economics from MIT in 1993. He also earned a Master of Public Administration degree from Harvard Kennedy School in 1991. He completed his residency training in internal medicine at Brigham and Women's Hospital, and he is board-certified in internal medicine. McClellan's research studies have addressed measuring and improving the quality of health care, the economic and policy factors influencing medical treatment decisions and health outcomes, estimating the effects of medical treatments, technological change in health care and its consequences for health and medical expenditures, and the relationship between health and economic well-being. He has twice received the Arrow Award for Outstanding Research in Health Economics.

In government

From 1998 to 1999, McClellan served as deputy assistant secretary of the Treasury for Economic Policy, where he supervised economic analysis and policy development on a wide range of domestic policy issues.

During 2001 and 2002, McClellan served in the White House. He was a member of the president's Council of Economic Advisers, where he advised on domestic economic issues. He also served during this time as a senior policy director for health care and related economic issues for the White House.

McClellan served as commissioner for the Food and Drug Administration (FDA) beginning November 14, 2002, becoming the first economist to hold that position. Originally from Austin, Texas, he is the brother of former White House Press Secretary Scott McClellan and the son of Texas comptroller Carole Keeton Strayhorn and attorney Barr McClellan.

He was administrator for the Centers for Medicare and Medicaid Services in the United States Department of Health and Human Services from 2004 to 2006. In this position, he was responsible for administering the Medicare and Medicaid programs, including Medicare Part D, the prescription drug benefit program engendered by the Medicare Prescription Drug, Improvement, and Modernization Act.

Following the resignation of Health & Human Services Secretary Tommy Thompson in 2004, McClellan was mentioned as a possible replacement, but President Bush ultimately nominated former Utah governor Mike Leavitt. On September 5, 2006, McClellan announced his resignation from his post in the department. He told The Associated Press he would be leaving the agency in about five weeks and would probably work for a think tank where he could write about improving health care in the United States.

McClellan is the founding chair and senior advisor of the Reagan-Udall Foundation, a public-private partnership between the U.S. Food and Drug Administration and industry founded in 2007.

During McClellan's tenure as Commissioner of the Food and Drug Administration (FDA), the makers of Plan B emergency contraception applied for over-the-counter status.

In May 2004, FDA commissioner Steven Galson rejected over-the-counter status for Plan B. The Center for Reproductive Rights then filed a lawsuit, and deposed Dr John Jenkins, director of the FDA's Office of New Drugs. Jenkins alleges that he learned in early 2004 that McClellan, then Commissioner of the FDA, had decided against approval even before the staff could complete their analysis. "I think many of us were very concerned that there were policy or political issues that came to play in the decision," Jenkins stated. He later said he did not know if anyone outside FDA influenced the decision.

McClellan said in his deposition that he was not involved in the decision to reject the initial Plan B application for non-prescription sales; he left the FDA in February 2004 to head the agency that runs Medicare and Medicaid. He also said that he was never told by anyone higher up in the Bush administration what to do about the application, although he did say that he "briefed" two White House domestic-policy advisors. The litigation is ongoing; no finding has been made for either side.