Monday, September 26, 2005

The Food and Drug Administration’s new acting commissioner is getting compliments for his government experience but criticism for his history of seeking quick drug approvals.

President Bush on Friday named Dr. Andrew C. von Eschenbach to replace former FDA Commissioner Dr. Lester M. Crawford, 67, who resigned suddenly as head of the agency that regulates food and prescription-drug marketing.

Dr. Crawford cited his age as the reason for leaving the federal agency. The FDA has been criticized in the past few years as popular drugs were pulled from the market, recalls of heart defibrillators and pacemakers increased, and controversy grew over wider access to emergency contraception.

Dr. von Eschenbach, a 63-year-old cancer survivor, said he plans to lead the FDA while keeping his job as director of the National Cancer Institute, the largest federal research facility under the National Institutes of Health (NIH).

He oversees a staff of 4,500 and a budget of $4.8 billion at the cancer institute, where he set a goal to eliminate suffering and death from cancer by 2015.

Dr. von Eschenbach is expected to run both agencies effectively, said Christina Pearson, spokeswoman for the Health and Human Services Department, which oversees the FDA and NIH.

“He is 100 percent committed to both of these jobs,” she said.

The Pharmaceutical Research and Manufacturers of America praised the speedy appointment of Dr. von Eschenbach to the FDA helm.

“His leadership, and the expertise of dedicated veteran FDA regulators, will allow the agency to continue its important work until a new commissioner is nominated and confirmed,” said Billy Tauzin, president and chief executive of the D.C. trade group.

But the Center for Science in the Public Interest questioned Dr. Eschenbach’s previous efforts to push for a faster drug-approval process.

Dr. von Eschenbach in 2003 promoted an FDA initiative to quicken the agency’s review process.

“We are highly supportive of this forward-looking effort to accelerate the development of critical new drugs, especially cancer treatments and preventives, and deliver them to patients faster,” he said at the time.

“The FDA does not need someone who will choose speed over safety, or else we’ll have a lot more Vioxx” cases, said Michael Jacobson, executive director of the Washington public health advocacy group.

Vioxx, an arthritis painkiller, was approved by the FDA but pulled from the market by maker Merck & Co. Inc. nearly a year ago after a company study linked the drug to increased risk of heart attack or stroke.

Since then, another very popular drug, Bextra, has been pulled from the market and other well-known drugs have received stronger warnings as the FDA stepped up its drug safety reviews.

Dr. von Eschenbach’s presence at the agency might bring stronger support for “personalized” medicines, tailor-made drugs for patients with particular genetic makeups, according to the Manhattan Institute, a New York economic think tank.

Dr. von Eschenbach told the institute in a June forum that personalized cancer treatments would lead the way in defeating the disease.

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