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Embattled FDA lacks stable leadership

In the wake of health warnings issued for popular prescription painkillers and the vaccine shortage, the Food and Drug Administration is facing increasing pressure to find a permanent, confirmed leader to right what some see as a sinking regulatory ship.
/ Source: a href="" linktype="External" resizable="true" status="true" scrollbars="true">The Washington Post</a

The Food and Drug Administration, which regulates almost one-quarter of the U.S. economy, has been without a permanent chief for almost two-thirds of the time that President Bush has been in office.

The agency also has had a high number of temporary appointees administering its centers, offices and divisions, including the key positions running the offices that evaluate new drugs and monitor the safety record of approved medications.

To many agency observers, the absence of settled leadership has become a significant problem. The agency, they say, is less able to respond quickly and effectively to emerging problems and has been weakened in the face of political, industry and sometimes consumer pressures to stray from the agency's science-based public health mandate.

In recent months, the FDA has been sharply criticized for its laissez-faire stance in the withdrawal of the arthritis drug Vioxx, its oversight of the company that was to provide half of the nation's flu vaccine this winter, and its handling of the sensitive issue of when and whether antidepressants should be prescribed for children. Friday's announcement that another popular arthritis drug, Celebrex, may also pose serious risks has raised the stakes further.

Agency defends status quo
The White House says the situation at the agency is no reason for concern, and FDA officials said their work has not been hampered by the lack of permanent leaders. Deputy Commissioner Janet Woodcock, who herself has served in an acting capacity for more than a year, said, "Our programs are set up to carry on. ... Transitions for us are pretty frequent and inevitable."

But others, including Sen. Charles E. Grassley (R-Iowa), who has held hearings into recent controversies at the FDA, are particularly concerned about the prevalence of "acting" leadership.

"Recent events make it obvious there's no time to waste in securing stronger leadership at the Food and Drug Administration," he said. "Permanent people need to be appointed to these jobs posthaste. ... Leadership is hampered by the term 'acting.' "

While the FDA's top job has been filled by temporary appointments for months at a time in previous administrations, the duration of the situation under Bush is unprecedented in modern times. Of the 48 months in Bush's first term, then-Commissioner Mark B. McClellan's 17-month tenure was the only period during which the position was permanently filled.

White House spokesman Trent Duffy acknowledged that the FDA had been without permanent leadership for a significant portion of the past four years. But Duffy said Bush believes that acting commissioner Lester M. Crawford is doing an "excellent" job and that he has all the "authorities and responsibilities" of a permanent commissioner. Duffy said the White House prefers having a permanent leader at the FDA, but there is no statutory or policy reason to rush the process.

Pharma ties draw fire
Some speculate, however, that there may have been political considerations. Edward M. Kennedy (Mass.), ranking Democrat on the Senate health committee, has said he would strongly oppose any nominee from the pharmaceutical industry; that stand may have made the administration less interested in filling the position before the election.

Paul C. Light, a New York University professor who works on the Brookings Institution's presidential appointments initiative, said the absence of permanent FDA leadership may be in part intentional. "There are some in the administration and in the industry who would rather have vacancies at FDA than an aggressive regulator," Light said. "The theory is that it is better to have no one there than someone who favors a proactive stance that might slow down the industry or raise hard questions about profitable drugs."

In four years, the Bush administration has sent only one name to the Senate for confirmation as food and drug commissioner — McClellan's in October 2002. Early this year, he was shifted to oversee the Medicare program as it implements a new prescription drug benefit.

Since then, Crawford, who was trained as a veterinarian and pharmacologist, has served as acting commissioner, taking on for the second time a role he and another FDA veteran filled for more than a year and a half before McClellan's confirmation. (Bush fired Clinton appointee Jane Henney immediately after taking office.) Naming permanent FDA commissioners became more complicated in 1988, when Congress required Senate confirmation as a way to make the job more powerful.

History of high turnover
Some argue that the additional burdens of the confirmation process have led to more and longer periods when the agency is run by temporary appointees. But others point out that the position was prone to high turnover and prolonged absences even before. When Frank Young became FDA commissioner in 1984, he noted that he was the fourth commissioner in seven years.

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.

"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."

Temps too gun-shy?
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.