McClellan nominated to FDA top spot

Mark A. DeSorbo

ROCKVILLE, MD—MARK MCCLELLAN, THE newly-appointed commissioner of the U.S. Food and Drug Administration (FDA), is already in the hot seat.

One problem likely to plague McClellan, 39, is that he has never managed a large staff. The FDA has more than 10,000 employees in offices spread across the country, and questions about his management skills are likely to come up during a confirmation hearing before the Health, Education, Labor and Pensions (HELP) Committee, a review that had not yet been scheduled at press time.

“Everything I hear is very positive about Mark McClellan,” says James G. Dickinson, editor and publisher of Dickinson's FDA Review (Camp Hill, PA).

“Large-organization administrative experience is desirable but not necessary; other commissioners have lacked it and still excelled, Dickinson adds. “He has the best political, professional and academic credentials I've seen in an incoming commissioner. Those who know him say he's impossible to dislike. All this augurs well for his term at this point.”

McClellan's nomination by President Bush comes nearly two years after a political standoff over who should fill the slot.

President Bush has said McClellan, a doctor and member of the president's Council of Economic Advisers and generally regarded as the nation's top health policy adviser, is uniquely qualified for the job.

“His experience will be very valuable as the FDA faces new challenges in the coming year, including the implementation of legislation I recently signed to help protect the nation from bioterrorism threats, speed access to breakthrough medical treatments, and make medical treatments safer,” the president says. “As head of the FDA, Mark will focus on empowering consumers and ensuring rapid access to products that are safe and effective.”

McClellan's nomination, announced in the White House Oval Office in late September, so far has the blessing of Sen. Edward Kennedy,

D-Mass, who chairs the committee that will oversee McClellan's confirmation to the post by the Senate.

“Dr. McClellan has impressive credentials both as a physician and as an economist, and I look forward to learning more about his views on issues critical to the FDA,” Kennedy says.

A standoff between Bush and Kennedy left the agency without a commissioner since the president took office. McClellan has not worked in any FDA-regulated industry, but has been a professor at Stanford University and deputy assistant secretary of the Treasury Department under President Clinton.

President George W. Bush and Dr. Mark McClellan (left) listen to Tommy Thompson, secretary of Health and Human Services, during a meeting in the Oval Office. During the meeting, President Bush announced Dr. McClellan as nominee to be commissioner of the Food and Drug Administration (FDA).
Click here to enlarge image


White House photo by Tina Hager.


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