Mark McClellan

Dr. Mark B. McClellan

Mark Barr McClellan (born June 26, 1963) is currently the Director of the Engelberg Center for Health Care Reform, Senior Fellow in Economic Studies and Leonard D. Schaeffer Director's Chair in Health Policy Studies at the Brookings Institution in Washington, DC. McClellan served as Commissioner of the United States Food and Drug Administration under President George W. Bush from 2002 through 2004, and subsequently as administrator of the Centers for Medicare and Medicaid Services from 2004 through 2006.^[1][2][3]

Education

After graduating from the University of Texas in 1985 majoring in English and Biology, 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.^[4] He also earned an M.P.A. from the Harvard University Kennedy School of Government 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.

Career

In government

From 1998-99, 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.^[5] 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 the post. 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.

In 2007, he was appointed as the chair of the Reagan-Udall Foundation, a public-private partnership between the U.S. Food and Drug Administration and industry.

In academia

Previously, McClellan was Associate Professor of Economics at Stanford University, Associate Professor of Medicine at the Stanford University School of Medicine, a practicing internist, and Director of the Program on Health Outcomes Research at Stanford University. He was also a Research Associate of the National Bureau of Economic Research and a Visiting Scholar at the American Enterprise Institute. Additionally, he was a Member of the National Cancer Policy Board of the National Academy of Sciences, Associate Editor of the Journal of Health Economics, and co-Principal Investigator of the Health and Retirement Study (HRS), a longitudinal study of the health and economic well-being of older Americans.

Role in Center for Reproductive Rights lawsuit

During McClellan's tenure as Commissioner of the 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.^[6]

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.^[6][7] The litigation is ongoing; no finding has been made for either side.

References

1. ^ Editorial (September 8, 2006). ""Departure of a Pragmatist"". The New York Times. http://www.nytimes.com/2006/09/08/opinion/08fri3.html. 
2. ^ Elisabeth Bumiller (September 15, 2003). ""White House Letter; A Spokesman Son, A Tell-All Dad, A Mum Mom"". The New York Times. http://query.nytimes.com/gst/fullpage.html?res=9907E3D71F3BF936A2575AC0A9659C8B63. 
3. ^ Robert Pear (February 21, 2004). ""Bush Chooses the F.D.A's Chief To Run Medicare And Medicaid"". The New York Times. http://query.nytimes.com/gst/fullpage.html?res=990DEFDC1E3DF932A15751C0A9629C8B63. 
4. ^ "Curriculum Vitae Mark B. McClellan" (PDF). NBER. May 2000. http://www.nber.org/vitae/vita365.pdf. Retrieved 2008-05-30. 
5. ^ FDA's economist in chief, Mark McClellan's views on healthcare make him popular with the drug industry, by Christopher Rowland, Boston Globe, January 18, 2004.
6. ^ ^{a b} "Plan B decision made before data review - FDA staff". Reuters via MSNBC.com: 4 August 2006. Accessed 4 August 2006.
7. ^ Julie Rovner (August 3, 2006). "Plan B Depositions Allege FDA Politically Motivated". NPR. http://www.npr.org/templates/story/story.php?storyId=5615463. Retrieved 2006-11-11. 

Selected publications

• McClellan M, McNeil BJ, Newhouse JP (1994). "Does more intensive treatment of acute myocardial infarction in the elderly reduce mortality? Analysis using instrumental variables". JAMA 272 (11): 859–66. doi:10.1001/jama.1994.03520110039026. PMID 8078163. http://jama.ama-assn.org/content/272/11/859.full.pdf. 
• Kessler D, McClellan M (1996). "Do doctors practice defensive medicine?". Q J Econ 111 (2): 353–390. doi:10.2307/2946682. http://qje.oxfordjournals.org/content/111/2/353.full.pdf. 
• Newhouse JP, McClellan M (1998). "Econometrics in outcomes research: the use of instrumental variables". Annu Rev Public Health 19: 17–34. doi:10.1146/annurev.publhealth.19.1.17. PMID 9611610. 
• Kessler DP, McClellan MB (2000). "Is hospital competition socially wasteful?*". Q J Econ 115 (2): 577–615. doi:10.1162/003355300554863. http://qje.oxfordjournals.org/content/115/2/577.full.pdf. 
• Cutler DM, McClellan M, Newhouse JP (2000). "How does managed care do it?". Rand J Econ 31: 526–48. PMID 11503704. http://www.economics.harvard.edu/faculty/cutler/files/How%20Does%20Managed%20Care%20Do%20It.pdf. 
• Cutler DM, McClellan M (2001). "Is technological change in medicine worth it?". Health Aff (Millwood) 20 (5): 11–29. doi:10.1377/hlthaff.20.5.11. PMID 11558696. http://content.healthaffairs.org/content/20/5/11.full. 
• Dranove D, Kessler D, McClellan M, Satterthwaite M (2003). "Is more information better? The effects of "report cards" on health care providers". J Polit Econ 111: 555–588. doi:10.1086/374180. http://www.kellogg.northwestern.edu/faculty/satterthwaite/research/2003-0520%20Dranove%20et%20al%20re%20Report%20Cards%20(JPE).pdf. 
• Fisher ES, McClellan MB, Bertko J, Lieberman SM, Lee JJ, Lewis JL, Skinner JS (2009). "Fostering accountable health care: moving forward in Medicare". Health Aff (Millwood) 28: w219–31. doi:10.1377/hlthaff.28.2.w219. PMC 2656392. PMID 19174383. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=2656392. 
• McClellan M, McKethan AN, Lewis JL, Roski J, Fisher ES (2010). "A national strategy to put accountable care into practice". Health Aff (Millwood) 29: 982–990. doi:10.1377/hlthaff.2010.0194. PMID 20439895. http://tdi.dartmouth.edu/documents/publications/A%20National%20Strategy%20by%20McClellan.pdf. 
• McClellan M, Benner J, Schilsky R, Epstein D, Woosley R, Friend S, Sidransky D, Geoghegan C, Kessler D (2011). "An accelerated pathway for targeted cancer therapies". Nat Rev Drug Discov 10 (2): 79–80. doi:10.1038/nrd3360. PMID 21283090. http://www.nature.com/nrd/journal/v10/n2/full/nrd3360.html. 

External links

• Search PubMed for McClellan's publications
• FDA's economist in chief, Mark McClellan's views on healthcare make him popular with the drug industry, by Christopher Rowland, Boston Globe, January 18, 2004. "He shares industry's view that profits should be protected to provide money and incentives to keep the United States at the forefront of new drug development. He is demanding speedier drug approvals from the FDA, echoing long-standing pleas from industry that the agency move faster and more predictably. He is lined up with the pharmaceutical industry in warning about potential health dangers of importing low-cost Canadian drugs. Instead of calling for lower US drug prices, he says, Canada and Western Europe should raise their prices on brand-name drugs to match. 'He's really been a disaster, possibly the worst commissioner I've seen,' said Dr. Sydney Wolfe, director of health research at consumer group Public Citizen in Washington. 'He is more well-liked by the pharmaceutical industry than any other commissioner I can remember.' Drug industry executives readily agree with the second notion."
• Press Gaggle with Scott McClellan and Dr. Mark McClellan Aboard Air Force One En Route Glendale, Arizona, August 29, 2005; Scott on Katrina readiness and Mark on upcoming changes to Medicare prescription drug benefit.
• Interviewed in The States Step In As Medicare Falters; Seniors Being Turned Away, Overcharged Under New Prescription Drug Program, by Ceci Connolly, Washington Post, Saturday, January 14, 2006. "The states that have stepped in to help have already incurred several million dollars in unexpected drug bills, but Mark B. McClellan, administrator of the federal Centers for Medicare and Medicaid Services (CMS), said he did not have the authority to reimburse them. He urged states, pharmacists and providers to work with his agency to collect reimbursements from insurance companies administering the prescription program."
• Interviewed in Troubles with Medicare Prescription Drug Program, PBS NewsHour with Jim Lehrer, January 16, 2006.

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Name	Macclellan, Mark
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Date of birth	June 26, 1963
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