Washington Editor

WASHINGTON - President Bush and members of Congress are expected to return to Washington next week following the month-long summer recess, and already rumors are flying about the possible nomination of an FDA commissioner.

This time around, the top name on the short list belongs to Bush adviser Mark McClellan, an internist who once worked as a professor of medicine and economics at Stanford University.

McClellan, 39, currently is a member of the White House Council of Economic Advisors. He's originally from Austin, Texas, and is a graduate of the University of Texas. He received his master's degree in public administration and his M.D. from Harvard, and his Ph.D. in economics from MIT. He served in 1998-99 at the Treasury Department as deputy assistant secretary for economic policy.

The FDA has operated without a full-time commissioner since Jane Henney, President Clinton's appointee, stepped down upon Bush's inauguration in January 2001. Meanwhile, Lester Crawford, a veterinarian and onetime director of the FDA's Center for Veterinary Medicine, has led the agency as deputy commissioner for the past eight months.

Several potential candidates, including a number of scientists, physicians and business people, have floated to the surface as possible leaders of the agency. But Jeff Trewhitt, spokesman for the Washington-based Pharmaceutical Research and Manufacturers Association, told BioWorld Today that there were intense rumors in late July indicating that McClellan would be nominated before the summer recess.

"The rumors just died and he didn't get nominated," he said. "Now whether he will get nominated when Congress returns in September, I don't know.

"I sort of think - this is just me speculating wildly - there are so many other things going on right now and I think the president's focus is on a potential war with Iraq and homeland security, and Congress still needs to appropriate funds for about 10 key federal departments - I think that's where the focus is," Trewhitt said. "I don't think they have to move very quickly on nominating a commissioner because they have such a strong acting commissioner in place right now."

Indeed, Trewhitt said Crawford impressed the industry when he announced the agency's plan to reassess its regulations for manufacturing practices last week, and he proved his leadership skills in successful negotiations with Congress in the reauthorization of the Prescription Drug User Fee Act. (See BioWorld Today, Aug. 23, 2002, and May 23, 2002.)

Bush has had some trouble finding a commissioner. Take, for example, the situation surrounding the nomination of Michael Astrue, a senior vice president of Transkaryotic Therapeutics Inc., of Cambridge, Mass. Astrue, a favorite within the biotechnology community, pulled his name from consideration after it was widely reported that Sen. Edward Kennedy (D-Mass.), who chairs the Senate Health, Education, Labor and Pensions Committee, which oversees the FDA, opposed any candidate from the industry and would not give Astrue a hearing. (See BioWorld Today, Nov. 2, 2001.)

When asked whether he thought McClellan could pass muster with Kennedy, Carl Feldbaum, president of the Washington-based Biotechnology Industry Organization, told BioWorld Today, "I wouldn't presume to be an expert on what pleases Sen. Kennedy. But the most recent candidate [McClellan] would seem to meet the administration's and the senator's criteria."

He added, "In tough economic times, the industry needs the regulatory stability that a highly qualified commissioner would bring."