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FDA's Reliance On Unconfirmed Chiefs Is Faulted

The FDA has more than 10,000 employees, and most work on scientific issues that are supposed to be independent of politics and the agency's leadership. But at drug companies and consumer groups, there is concern that the absence of permanent leadership has enfeebled the agency.

"Not having a permanent commissioner doesn't send a good message," said Arthur Aaron Levin, director of the Center for Medical Consumers in New York and a member of the FDA's advisory panel on drug safety. He worries that the agency is not doing enough to make sure drugs are safe.

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"Bureaucracies have a life of their own and need to feel their work is a high priority," Levin said. "But not having permanent leadership means you're not a high priority."

Sam Kazman, general counsel of the Competitive Enterprise Institute, feels the lack of a commissioner is a problem for a different reason. In the aftermath of the Vioxx debacle, in which the FDA was widely seen as slow to react to safety concerns, he fears that the FDA will become gun-shy about approving new drugs.

"When you have temps in high places at FDA, the agency's traditional tendency towards deadly overcaution becomes worse," Kazman said.

Alan Goldhammer, associate vice president for U.S. regulatory affairs for the brand-name drug industry trade association, Pharmaceutical Research and Manufacturers of America, said the FDA is continuing to function normally but is weakened.

"Even though Dr. Crawford has testified at a number of hearings and clearly is in charge of daily operations," Goldhammer said, "there is a difference when the person in charge has gone through the whole confirmation process. That person is in a better position to argue for the resources they need and to present the views of the agency."

Goldhammer also said that having an acting commissioner in charge makes it more likely that other important positions will be filled by interim appointments. Decisions on naming potentially long-serving employees often await a permanent commissioner, he said.

Among the acting appointees holding sensitive posts now are Steven Galson, acting director of the Center for Drug Evaluation and Research, and Paul Seligman, acting director of the Office of Drug Safety. Both have been in controversies that have called into question their ability to ward off political pressure.

Galson came under strong criticism from many in the medical community for refusing to allow the emergency contraceptive Plan B to be sold as an over-the-counter drug, even though both FDA staff and an advisory panel had concluded decisively that the switch would be safe and valuable to consumers. Galson and Seligman have became embroiled in the Vioxx controversy and allegations that the agency sought to stifle dissent from drug safety officer David J. Graham.

White House spokesman Duffy said the administration had no timetable for nominating a new permanent commissioner, but experience suggests the process may be time-consuming. Before McClellan got the job in 2002, at least three men prominent in the pharmaceutical community were quietly brought to the White House as serious contenders, and just as quietly were rejected.

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