Series of fill-in leaders is seen hampering FDA effectiveness

THE BALTIMORE SUN

WASHINGTON -- Four months after the White House appointed Dr. Andrew C. von Eschenbach to be acting commissioner of the Food and Drug Administration, he remains just that - temporary head of an agency that has become accustomed to fill-in leaders under the Bush administration.

The FDA's top post has seen no fewer than four interim commissioners over all but 18 months of the Bush presidency, generating growing concern from members of Congress from both parties, various interest groups and industry.

A permanent leader, they contend, would be more focused on long-term strategic planning and could help the FDA gain more funding from Congress for prompt approval of new drugs and medical devices.

"Now we have a temp from NIH standing sentry over our food and our drugs. We need to have a full-time, competent person who's doing this," Sen. Barbara A. Mikulski, a Maryland Democrat, said in a recent radio address.

Senate Finance Chairman Charles E. Grassley of Iowa and Health Committee Chairman Michael B. Enzi of Wyoming, both Republicans, have urged President Bush to pick a permanent commissioner.

Rep. Mark E. Souder, a Republican from Indiana, blamed the absence of a permanent commissioner for the FDA's failure to tackle such public health issues as the diversion of prescription drugs for illegal use and the potential sale of the morning-after pill without a prescription.

"A continuous 'interim director' at FDA is like a baby sitter left in charge of the children indefinitely - you don't want to leave important decisions to that person," Souder, who chairs a House subcommittee on drug policy, said through a spokesman.

Erin Healy, a White House spokeswoman, said the administration was moving forward on nominating someone as soon as possible. Von Eschenbach, she said, was "fully engaged" in the FDA and carries the same authority as a permanent commissioner.

During the Bush administration, the agency has been led by an interim chief much longer than by a permanent one - for 42 of Bush's 60 months as president. Some former agency officials say that reflects a lack of enthusiasm for food and drug regulation at the White House.

"This White House has, from the beginning, shown very little interest in the health establishment," said William W. Vodra, a former FDA associate chief counsel for drugs, who now represents pharmaceutical companies. "They came here with an agenda that did not include FDA issues as major items."

But the agency has been led by acting commissioners for long periods under other presidents. And the current situation, some former officials say, might simply reflect the difficulty of finding someone acceptable to conservatives, industry and other interest groups.

According to lawyers and lobbyists, White House aides have interviewed candidates for commissioner and a nominee could be named any day, or the job formally given to von Eschenbach.

But the Bush administration might also have chosen to avoid an inevitable confirmation fight. Democratic senators would almost certainly block any nominee, at least until the FDA took long-delayed action on easing access to the morning-after pill.

A cancer survivor and urologic surgeon by trade, von Eschenbach, 64, took the FDA job after Lester M. Crawford abruptly resigned last August. Von Eschenbach, a Bush family friend, had been director of the prestigious National Cancer Institute and still holds that title. Neither he nor other top agency officials were available for comment.

At the time of his FDA appointment, von Eschenbach sent an e-mail to advocates of cancer research suggesting that his FDA appointment was temporary and that he could do both jobs.

Complaints about conflicts of interest quickly arose, however, because the NCI supports research into experimental drugs that require FDA approval to be tested in humans. So von Eschenbach relinquished day-to-day leadership of the NCI and pledged to recuse himself from FDA matters involving the cancer institute.

Activists, scientists and other critics complain that addressing one of the FDA's most pressing issues - improving the safety of drugs and medical devices - will be difficult without a permanent agency head.

"Most people say having an acting commissioner makes the FDA a weak player," said Dr. Wayne A. Ray, a professor of preventive medicine at the Vanderbilt University School of Medicine and a co-author of a recent article in the New England Journal of Medicine urging a reorganization of the FDA to assure drug safety.

Agency budgets, former officials say, have not increased to keep up with rising salaries and other non-discretionary spending, forcing cuts in many programs. The absence of a permanent commissioner has contributed to that, they believe.

Nevertheless, lawyers and lobbyists expect some long-standing initiatives to proceed, including more modest efforts to improve the safety of drugs and devices. Von Eschenbach's recent announcement of labeling changes is an example of the drug safety push.

An FDA effort to speed the approval of drugs and devices - something von Eschenbach has advocated at the National Cancer Institute - is also proceeding. The FDA announced one bid to speed up the development of drugs last month, when it issued new guidelines on early study of experimental treatments that make it easier for researchers to produce and then test.

The commissioner's role, former officials say, is setting policy priorities, implementing reforms and securing the biggest budget possible. It's in those realms where a commissioner, trusted by the White House and confirmed by the Senate, can make a difference.

"There are issues that are out of the routine that require the leadership of a commissioner," said Michael Taylor, a former FDA deputy commissioner for policy now at the University of Maryland. "It's on the new-initiative side where lack of permanent leadership is a factor."

As long as he stays at the FDA, von Eschenbach might be better positioned than previous acting commissioners to make a difference because of his ties to the president.

"But the fact that he's on good terms with the White House doesn't necessarily mean he's on good terms with the Congress," said Richard A. Merrill, a University of Virginia law professor who was an FDA counsel in the 1970s.

jonathan.rockoff@baltsun.com

FDA leadership

The Federal Drug and Food Administration under the Bush administration

Jan. 2001: President Bush comes to office and President Bill Clinton's FDA commissioner resigns. Dr. Bernard A. Schwetz, acting principal deputy commissioner, effectively leads the agency.

Feb. 2002: Bush appoints Dr. Lester M. Crawford Jr. to be deputy FDA commissioner. He effectively runs the agency.

Nov. 2002: Dr. Mark B. McClellan begins serving as FDA commissioner.

March 2004: McClellan leaves FDA to oversee Medicare and Medicaid. Crawford begins serving as acting FDA commissioner.

July 2005: Crawford becomes permanent FDA commissioner.

Sept. 2005: Crawford abruptly resigns. Bush appoints Dr. Andrew C. von Eschenbach to serve as acting FDA commissioner.

[Source: www.fda.gov/oc/commissioners/default.htm]

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