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October 14, 2002
Volume 80, Number 41
CENEAR 80 41 p. 12
ISSN 0009-2347


GOVERNMENT

FDA NOMINEE SAILS THROUGH HEARING
McClellan soon expected to be confirmed as commissioner

BETTE HILEMAN

Mark McClellan, who has been nominated by President George W. Bush to become commissioner of the Food & Drug Administration, sailed easily through his Oct. 7 Senate confirmation hearing. His nomination was approved unanimously by the Health, Education, Labor & Pensions Committee on Oct. 9, and his confirmation by the full Senate is expected shortly.

In his opening statement, committee Chairman Sen. Edward M. Kennedy (D-Mass.) noted McClellan's impressive background. "He was an associate professor of economics and medicine at Stanford University. He is a member of the President's Council of Economic Advisers, and he's also a major adviser on health policy to the President," Kennedy said. The panel was generally supportive of McClellan, declining to ask extremely controversial or probing questions.

McClellan told the panel that FDA should be able to maintain high standards of safety while streamlining the process for approving drugs and medical devices. He said he doesn't think there needs to be "a conflict between stressing safety concerns and handling them appropriately, and approving drugs quickly."

One of his top priorities will be reducing the high turnover rate among professionals and improving the work environment. In recent years, FDA professionals have been leaving much faster than do their counterparts in similar government agencies. He also said he wants Congress to pass the medical device user fee bill and the animal drug user fee bill, which are now being considered in the House. User fee acts require FDA to act on applications within certain deadlines and collect money from industry to pay for about half the cost of drug and device approval (see page 43).

Both drug industry groups and public health advocates say they are pleased that FDA will soon have a commissioner after a 20-month hiatus.



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