Effort to fill top FDA job delayed yet again

Efforts to fill the top job at the Food and Drug Administration, which has been leaderless since the start of the Bush administration, appear to be delayed again, this time because the administration's leading candidate cannot be spared from his current job.

Over the summer, speculation that the president would tap his top health policy adviser, Mark McClellan, for the sensitive-and hard-to-fill-FDA post was one of the worst-kept secrets of the normally tight-lipped Bush administration.

The administration has had particular difficulty finding someone to head the agency, in part because Senate Health, Education, Labor and Pensions Committee Chairman Edward Kennedy, D-Mass., has said he will not approve any nominee with an industry background.

"It would be unprecedented for the commissioner to be appointed from an industry regulated by the FDA," Kennedy and six other committee Democrats wrote Bush last summer.

The 39 year-old McClellan-a Harvard-trained physician who also has a Ph.D. in economics from MIT-has little experience with regulatory issues, but is considered confirmable. His lengthy resume includes a stint in the Clinton administration's Treasury Department, and the Democratic-controlled Senate has already confirmed him once, in the summer of 2001, as a member of the President's Council of Economic Advisers.

Committee Republicans are already enthusiastic. A spokeswoman for Sen. Bill Frist, R-Tenn., ranking member on the Health, Education, Labor and Pensions Public Health Subcommittee, said the senator "won't speculate on who the nominee will be, but as far as Mark McClellan goes, he has the highest praise for him and believes he is invaluable to the administration."

But it is that air of indispensability that appears to be the problem for McClellan, who has been quietly visiting committee members.

"It's a question of timing," said a House GOP McClellan supporter. "He's heavily involved in this year's healthcare endgame," said the GOP aide, including continuing negotiations on Medicare prescription drugs and provider payments, "and the administration will have to decide when they want to pull him out."

The only apparent question mark appears to be McClellan's lack of regulatory experience. Committee Democrats, including Kennedy, declined to comment on the prospective nominee, but Sen. Ron Wyden, D-Ore., a longtime FDA watcher, said it gives him some pause.

"This is a critically important appointment," said Wyden. "That fact that he has no direct, hands-on regulatory experience is an issue that has to be inquired into fully."

Supporters insist McClellan's lack of FDA-related experience should not be a problem.

"If you look at his writings, you can see he's done a lot of clinical stuff, a lot of stuff on quality," said the House GOP aide.

McClellan defended his background following a speech Tuesday, while declining comment on whether he would be nominated to head FDA. "I worked in a teaching hospital," he said. "I was involved with a lot of drug trials."