Acting FDA chief faces conflict

Keeping two jobs may be one too many for Dr. Andrew C. von Eschenbach, some say

September 28, 2005|By RICARDO ALONSO-ZALDIVAR | RICARDO ALONSO-ZALDIVAR,LOS ANGELES TIMES

WASHINGTON -- President Bush's new Food and Drug Administration chief could face a built-in conflict of interest if he follows through with his plan to keep his present position as head of the National Cancer Institute while also taking over the FDA, some leading physicians and consumer activists caution.

Dr. Andrew C. von Eschenbach expressed confidence this week that he can do both jobs well. But because the FDA has an oversight role in the cancer institute's drug development research, some experts foresee problems - especially since von Eschenbach is publicly committed to accelerating approval of some anti-cancer drugs. Other experts said each job is so demanding that it would be nearly impossible to do justice to both.

Questions raised

Meanwhile, von Eschenbach raised further questions by suggesting Monday that his FDA role may only be temporary.

The main pharmaceutical trade group applauded von Eschenbach's appointment as FDA chief. "The administration has moved quickly and placed the Food and Drug Administration in good hands, allowing the FDA to move forward on a number of important issues," the Pharmaceutical Research and Manufacturers of America said in a statement.

But critics suggested that the proposed arrangement could actually make it harder for the FDA to avoid controversy and move forward.

"It is very hard for him to be in both positions and deal with requests regarding cancer drugs," said Dr. Curt Furberg, a professor at Wake Forest University, who has advised the FDA on safety issues. "I really see a potential conflict. As head of NCI, he may be very eager to get drugs approved by FDA, particularly drugs that have been developed and tested by NCI."

"These are agencies with big budgets that make a lot of decisions that influence the health of individual Americans," said Dr. Jeffrey Drazen, editor in chief of the New England Journal of Medicine. "What we really need are two highly qualified, motivated individual leaders."

"I think it's alarming that he's going to run both jobs at the same time," said Dr. Paul D. Stolley, a former chairman of the University of Maryland's Department of Epidemiology and Preventive Medicine who worked from 2000 to 2001 as a visiting scientist at the FDA. "It's hard enough to run the FDA, alone. Almost nobody's done it well, for years and years." Von Eschenbach's appointment as acting commissioner was announced Friday after the unexplained resignation of Lester M. Crawford, who won Senate confirmation two months ago.

Rocky start

Crawford had gotten off to a rocky start after he delayed a promised decision on whether to allow over-the-counter sales of the so-called morning after contraceptive.

Health and Human Services Deputy Secretary Michael Azar told senior officials Monday that Crawford's departure involved a personal matter, an administration official said.

Crawford's resignation came at a delicate time because the agency has been under fire because of its oversight of drug safety.

In an e-mail Monday to advocates for cancer research, von Eschenbach called his FDA appointment "an interim role."

"I will work to ensure an orderly transition of a new, permanent at the FDA," von Eschenbach wrote.

In its oversight role, the FDA must approve institute-sponsored clinical trials involving humans. It also decides whether drugs developed through such studies may be marketed.

Once a drug has been approved, physicians have broad latitude in prescribing it, even for conditions not authorized by the FDA.

Von Eschenbach "is talking about getting drugs to terminally ill patients faster, and that's a laudable goal," said Diana Zuckerman, president of the National Research Center for Women and Families. "But you can't approve a drug and assume it will only be used for terminally ill patients. Everything he has been quoted as saying suggests he doesn't understand how the FDA works."

Ricardo Alonso-Zaldivar writes for the Los Angeles Times.

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