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FDA's Reliance On Unconfirmed Chiefs Is Faulted

By Marc Kaufman
Washington Post Staff Writer
Sunday, December 19, 2004; Page A01

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.

Friday's Question:
It was not until the early 20th century that the Senate enacted rules allowing members to end filibusters and unlimited debate. How many votes were required to invoke cloture when the Senate first adopted the rule in 1917?

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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.

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.

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.

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.

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