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| {{See also | Emergency contraception#International availability}} | {{See also | Emergency contraception#International availability}} | ||
| During McClellan's tenure as Commissioner of the ], the makers of Plan B ] applied for ] status. | |||
| During McClellan's tenure as Commissioner of the ], the makers of Plan B ] applied for ] status. The application for OTC status was supported by the ], the ], the ], the ], and other leading U.S. medical organizations.<ref>"". FDA.gov: December 16, 2003. Accessed August 2, 2006.</ref> On ], ], an advisory committee to the FDA recommended that Plan B be made available over the counter.<ref>"". CNN.com: December 17, 2003. Accessed April 28, 2006.</ref> | |||
| In May 2004, after McClellan left the FDA to head Medicaid, the FDA rejected over-the-counter status for Plan B. The Center for Reproductive Rights 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 scientific analysis.<ref name="multiple">"". Reuters via MSNBC.com: 4 August 2006. Accessed 4 August 2006.</ref> | |||
| McClellan stated that he gave regular updates to the White House as a matter of course, but denied that he was told what to do by the Bush Administration with regard to Plan B. |
In his own deposition, McClellan stated that he gave regular updates to the White House as a matter of course, but denied that he was told what to do by the Bush Administration with regard to Plan B. Part of his deposition read, "...if I was being given any direction on how I should act on this application, I would have remembered that because that never happened."<ref name="multiple"/> | ||
| ==Notes== | ==Notes== | ||
Revision as of 19:32, 11 November 2006
Mark B. McClellan (born June 26, 1963) was sworn in as Administrator for the Centers for Medicare and Medicaid Services in the United States Department of Health and Human Services on March 25, 2004. In this position, he is responsible for administering the Medicare and Medicaid programs. 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. On October 16, 2006, the AEI-Brookings Joint Center announced that Mark McClellan would join as a visiting Senior Fellow.
Dr. McClellan previously served as Commissioner for the Food and Drug Administration (FDA) beginning November 14, 2002. 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.
Previously, Dr. McClellan was Associate Professor of Economics at Stanford University, Associate Professor of Medicine at Stanford Medical School, 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. From 1998-99, he was 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, Dr. 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.
Dr. 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. 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 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.
Role in Plan B controversy
See also: Emergency contraception § International availabilityDuring McClellan's tenure as Commissioner of the FDA, the makers of Plan B emergency contraception applied for over-the-counter status.
In May 2004, after McClellan left the FDA to head Medicaid, the FDA rejected over-the-counter status for Plan B. The Center for Reproductive Rights 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 scientific analysis.
In his own deposition, McClellan stated that he gave regular updates to the White House as a matter of course, but denied that he was told what to do by the Bush Administration with regard to Plan B. Part of his deposition read, "...if I was being given any direction on how I should act on this application, I would have remembered that because that never happened."
Notes
- ^ "Plan B decision made before data review - FDA staff". Reuters via MSNBC.com: 4 August 2006. Accessed 4 August 2006.