Washington Editor

WASHINGTON - Lester Crawford was selected to become the FDA's next permanent commissioner, confirming recent speculation and despite some grumbling about drug safety oversight at the agency, after serving for nearly a year as its interim boss.

President Bush late Monday said he would nominate Crawford, who has a longtime background at the FDA. In addition to his time as acting commissioner, the 66-year-old has previous experience as the agency's deputy commissioner and as administrator of the food safety and inspection service. The FDA has been without a permanent commissioner since Mark McClellan left almost a year ago to serve as administrator of the Centers for Medicare & Medicaid Services.

Crawford's selection was lauded by BIO, the Biotechnology Industry Organization in Washington.

"The agency works more efficiently with a confirmed commissioner," Michael Werner, the trade association's chief of policy, told BioWorld Today. "This lets the employees, the public and stakeholders know that there's Senate-approved leadership so any decisions that were being held pending appointment can go ahead."

Crawford's nomination remains subject to Senate confirmation. The FDA falls under the Department of Health and Human Services, which recently had its own leadership change as Mike Leavitt assumed the top spot last month after receiving Senate confirmation.

"To millions of people, the FDA brand is a seal of quality and safety that is based on the best science in the world," Leavitt said, "and I look forward to working with Dr. Crawford to build on that trust in the 21st century."

Almost concurrent with news of Crawford's nomination, Leavitt spent time at the FDA Tuesday to discuss his plans to implement at the agency the Drug Safety Oversight Board, an independent body developed to foster a culture of more openness and better oversight. The board is being established to monitor drug safety issues and to provide doctors and patients information about the risks and benefits of medicines.

In managing safety concerns, the new body will recommend information and updates for placement on the Drug Watch, resolve disagreements over approaches to safety issues, assess the need for MedGuides and oversee the development and implementation of broad safety policies. The board will be made of FDA staff and medical members from other HHS agencies and government departments, HHS said, and its members will consult with outside medical experts and representatives of patient and consumer groups.

The safety issue has been a lightning rod for critics of the FDA during Crawford's tenure as acting commissioner, especially over the past six months following the market withdrawal of Vioxx (rofecoxib). The painkiller was yanked off the shelves in September by its manufacturer, Merck & Co. Inc., of Whitehouse Station, N.J., over safety concerns related to increases in cardiovascular complications for patients taking the Cox-2 inhibitor. That issue, among other charges related to Crawford's past relationships with the animal drug and food industries, is of concern to critics.

Those critics will be watching today, as the FDA begins a three-day meeting to contemplate the overall benefit-to-risk considerations for the entire Cox-2 inhibitor class of drugs.

Crawford's background includes a stint as the director of the Center for Food and Nutrition Policy at Georgetown University and Virginia Tech, and he has served as an adviser to the United Nations' World Health Organization for almost 20 years. He is a member of the National Academy of Sciences' Institute of Medicine and is a fellow of the UK's Royal Society of Medicine.

His educational background includes a doctorate of veterinary medicine from Auburn University and a Ph.D. in pharmacology from the University of Georgia. He also has an honorary doctorate from Budapest University.

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