Acting FDA chief keeps a hand in NCI business

Acting Food and Drug Administration Commissioner Andrew von Eschenbach’s full-time commitment to the beleaguered agency is not as settled as it appeared to be a few weeks ago.

Von Eschenbach came under fire for planning to split his time between overseeing both the Food and Drug Administration (FDA) and the National Cancer Institute (NCI), where he has been director since 2002. Amid a flurry of criticism, he promised to concentrate on the FDA and to leave the job of running the cancer-research agency to a deputy.

Von Eschenbach is not as divorced from the NCI as many observers believed, however.

A spokesperson for the Department of Health and Human Services (HHS) confirmed that he continues to participate in the management of the cancer agency, which is part of the National Institutes of Health. Von Eschenbach is officially still director of the NCI and has been active in steering the course of the research agency since being named acting chief of the FDA on Sept. 26.

“Dr. von Eschenbach retains the title, and he is still involved in the high-level strategic direction” of the NCI, the spokesperson said. Day-to-day management of the agency is the responsibility of John Niederhuber, an NCI official who has been given the ersatz title of chief operating officer.

Von Eschenbach issued a memo Sept. 30 to FDA employees declaring his dedication to the agency. “I am now devoting my energies to the work of the FDA,” he wrote in the memo, which was widely circulated on the Hill.

But von Eschenbach was quoted as NCI director in a press release issued yesterday, as he was Oct. 3 and Oct. 4, and his weekly “Director’s Update” column on the NCI website appeared Oct. 4. Niederhuber penned the Oct. 11 column under the heading “Guest Update.”

The FDA website redirects viewers to the NCI site for biographical information on von Eschenbach. He is quoted as acting FDA commissioner in a Sept. 28 press release.

Even if he were to sever ties completely with the cancer institute, questions linger about potential conflicts of interest arising if the FDA were to consider approval for a drug developed by NCI scientists or with NCI funding under von Eschenbach’s watch. His vow not to participate in such decisions has not satisfied his critics.

The Bush administration is not likely to nominate von Eschenbach to the FDA job permanently, and he is expected to eventually return to the NCI full time.

HHS Secretary Mike Leavitt on Oct. 4 told Bloomberg Television, “Andy is acting commissioner, and I suspect that will be his status until we fill [the position] permanently.” Former FDA Commissioner Lester Crawford resigned last month for reasons that are still unclear.

The White House faces a tough fight over whoever will be the FDA nominee. The politics of drug regulation have taken on a decidedly partisan turn. Strongly held philosophical differences over abortion, sexual health and the role of the FDA as a regulator divide the Senate largely, but not entirely, along party lines.

Crawford’s sudden departure came only two months after the White House and Senate GOP secured his confirmation amid frustration about the FDA’s failure to rule on whether the emergency-contraceptive “morning-after pill” known as Plan B should be sold without a prescription.

Crawford faced holds on his nomination from Democratic Sens. Patty Murray (Wash.) and Hillary Rodham Clinton (N.Y.) that were lifted only when Leavitt guaranteed a final decision on the drug — a promise on which Crawford reneged. Sen. Tom Coburn (R-Okla.) also threatened a hold over the content of warning labels on condoms, while Sen. David Vitter (R-La.) weighed stalling the nomination to force Senate action on a bill to permit the importation of prescription medicines from abroad.

Furthermore, widely divergent views about how the FDA should balance encouraging the development of new drugs with promoting their safety also divide the Senate.

Uncertainty over what brought about Crawford’s resignation and frustration among key senators about the ultimately wasted effort expended to remove the obstacles to his nomination also could impede the progress of the next nominee.