Senate approves new head of FDA

Von Eschenbach became acting chief in Sept. '05

December 08, 2006|By New York Times News Service

The Senate confirmed Dr. Andrew C. von Eschenbach as commissioner of the Food and Drug Administration yesterday, with some lawmakers expressing hope that his leadership would bring stability to an agency hobbled by turnover and criticized for poor oversight of the nation's drug supply.

Von Eschenbach, 65, a surgeon who has been treated for melanoma and prostate cancer, became acting FDA commissioner in September 2005 after the abrupt resignation of Dr. Lester M. Crawford.

Previously, he had served as chief academic officer at the M.D. Anderson Cancer Center in Houston and had led the National Cancer Institute.

In the past 10 years no commissioner has served more than two years. A report released in September by the Institute of Medicine, part of the National Academy of Sciences, deplored a "lack of stable leadership" at the agency. The report said that turnover at the helm would compromise efforts to improve the effectiveness of the agency, which the report criticized as hobbled by internal squabbles, poor management and outdated rules.

Von Eschenbach was formally nominated to the position of commissioner in March, but his confirmation was delayed by a series of objections in the form of "holds" by senators from both parties who said they were protesting issues ranging from the delay of Plan B emergency contraceptives to the administration's stance on drug re-importation, or the purchase of prescription drugs in countries where they are cheaper.

By Senate tradition, any member may delay a nominee through a hold, but the majority leader has the discretion to override it.

Before delivering a farewell speech yesterday on the Senate floor, Sen. Bill Frist, the retiring majority leader, called for a procedural vote to bring von Eschenbach's name before the full Senate for confirmation, ignoring remaining "holds" from two fellow Republicans.

Frist, who was a cardiac surgeon before he joined the Senate, said that von Eschenbach had done a "superb" job as acting commissioner.

Von Eschenbach's confirmation, by a vote of 80-11, came despite the strong objections of Sen. Charles E. Grassley, an Iowa Republican who has been an outspoken critic of the agency.

Grassley had placed a hold on von Eschenbach's nomination, accusing him of refusing to turn over evidence needed for a Senate Finance Committee investigation of an antibiotic, Ketek.

Ketek, which is manufactured by the French company Sanofi-Aventis, was approved in 2004 despite the misgivings of employees at the drug agency. It has since been linked to liver problems and deaths. The FDA has scheduled advisory panel hearings for next week on whether to keep it on the market.

Former employees of the agency have told Grassley, who leads the finance committee, that von Eschenbach held a meeting and, using sports metaphors, hinted that they would be retaliated against, or be "off the team," if they discussed their complaints about Ketek outside the agency.

Von Eschenbach has said he did not intend the comments as a threat.

"The American people don't want the government making decisions about what's good for them behind closed doors," Grassley said.

Sen. Michael B. Enzi, a Wyoming Republican who is head of the Health, Education, Labor and Pensions Committee, urged von Eschenbach's confirmation, citing the need for a permanent leader.

"The FDA has been without a confirmed commissioner for all but 18 months of the last 5 1/2 years," Enzi said. "Ever see a business that could run for 5 1/2 years without a boss except for 18 months?"

Von Eschenbach, a urologic surgeon, has said he believes that new drugs should be made available as quickly as possible, particularly those intended to treat life-threatening illnesses.

As acting commissioner, von Eschenbach moved this year to make Plan B, the emergency contraceptive, available to adults without a prescription, silencing some administration critics who had complained that conservative political interference at the agency had blocked the drug's broader availability.

Sen. David Vitter of Louisiana, who had also put a hold on the confirmation, said he was protesting the administration's strict policy that prohibits Americans from buying their drugs in Canada, where they are up to 50 percent cheaper.

Von Eschenbach replaces Crawford, who resigned from the post in the wake of questions about discrepancies in his financial disclosure forms. Crawford pleaded guilty in October to federal misdemeanor charges of lying on those forms about stock holdings in companies regulated by the agency.

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