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By Brian Reid

 August 13, 2003 | Mark McClellan is distinct from previous FDA commissioners. It has been a half-century since the agency had a leader who didn't make his or her name in medicine or pharmacy. Though McClellan is a board-certified internist with an M.D. from Harvard University and a Ph.D. in economics from MIT, he made his mark as a Stanford economist before joining the Clinton-era Treasury Department.

After a brief return to academia, McClellan joined George W. Bush's Council on Economic Advisors in 2001, serving the president until he ascended to the top post at the FDA.

"He is far and away the most politically trained commissioner we've ever had because of his tenure at the White House," says Ira Loss, an equities analyst specializing in FDA issues for Washington Analysis.

McClellan has a Texas tie to the president: His mother is a friend of the Bush family, was a three-time mayor of Austin, and now serves in the state government. And he has a blood tie to the West Wing: His brother Scott was recently named White House press secretary, replacing Ari Fleischer. That background is only the beginning of the differences between McClellan and prior FDA commissioner Jane Henney, a low-key oncologist who spent her career moving back and forth between academic posts and spots at both the FDA and the National Institutes of Health.

Committed to neutrality on political questions, Henney played no role in administration policies beyond the purview of the FDA and stripped the agency of all but one political appointee, a staff position. Since Bush took office, however, the number of political appointees has again expanded, including the deputy commissioner and the agency's chief lawyer.

It's still too early to predict what stamp McClellan will leave on the FDA. But perhaps there are hints in what he has written. In his widely read 2001 Health Affairs article, he drew on his medical and economic training to critique new costly treatments. McClellan picked apart five medical conditions from heart attack to depression and found that in four of the five cases, the increases in cost were well worth the benefits. The fifth case — the price versus the benefit in treatment of breast cancer — he decided was basically a wash.

A new brand of technocrat, McClellan seems eager to adopt new technologies, even when they cost more, as long as the benefit is proven and substantial.



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