Medical Device Daily Washington Editor

President George Bush on Monday said he plans to nominate Lester Crawford to head the FDA. Crawford has served as acting commissioner since March 2004, when Mark McClellan left the agency to lead the Centers for Medicare & Medicaid Services (Baltimore).

Mike Leavitt, the newly named secretary of the Department of Health and Human Services (HHS), which oversees the FDA, called Crawford “an outstanding choice“ for the job.

“Dr. Crawford has dedicated his career to advancing the nation's public health and will lead the way as we enter a new era of individualized medicine and rapidly developing science,“ Leavitt said. “With Dr. Crawford's leadership, FDA will provide the world's safest drugs and empower citizens with the tools they need to make informed choices about their health.“

Dan Schultz, director of the FDA's Center for Devices and Radiological Health (CDRH), told Medical Device Daily that removing the adjective “acting“ from Crawford's title is “extremely important,“ not because it has anything to do with how seriously Crawford takes his responsibilities but because of public perception.

“People perceive the term 'acting' as something that makes us less able to do what we need to do and move forward with new initiatives,“ Schultz said. “From where I sit, having somebody I have dealt with and I know supports the device program and what we are trying to do is a great thing.“

Schultz said Crawford has been “very supportive“ of CDRH initiatives, including the user fee program. He stressed that the appointment maintains continuity and will keep the center's programs moving forward without delay.

“FDA has its strategic plan, [CDRH has a] strategic plan, and my goal is to make those things happen, not to start all over again,“ he said. “I think we have done enough planning, now is the time to get some work done.“

Though Crawford may not be “as dynamic as some other people who have been there in the past,“ according to Schultz, he said Crawford's understanding of the agency will be “critical.“

“He has a steady hand; he understands the regulatory process; he understands science; and he understands the political process,“ Schultz said. “I think he is going to do a great job.“

Pamela Bailey, president of the Advanced Medical Technology Association (Washington), said in a statement that her organization looks forward to continued work with Crawford and that he understands “the unique characteristics of the medical technology industry.

“Dr. Crawford's experience will be invaluable as Congress and [the] FDA craft legislation this year that will add predictability and stability to the medical device user fee program and allow for the program's continuation beyond the current fiscal year,“ Bailey said.

Crawford's nomination comes at a time when the spotlight has been turned squarely on the FDA's drug approval process. The agency has come under fire recently as slow to respond to post-market studies and then been forced to pull some high-profile drugs from the market due to serious health risks.

Yesterday, in response to calls for more careful post-market review, Leavitt announced the creation of an independent Drug Safety Oversight Board to monitor FDA-approved drugs in order to update physicians and patients concerning emerging information on risks and benefits.

“The public has spoken and they want more oversight and openness,“ Leavitt said during a meeting with FDA employees at the agency's headquarters in Rockville, Maryland. “They want to know what we know, what we do with the information and why we do it. We will address their concerns by cultivating openness and enhanced independence.“

Leavitt said the new group will be comprised of members from FDA, medical experts from other HHS agencies and government departments and will consult with outside medical experts and representatives of patient and consumer groups.

The new board is expected to create a drug safety web page with updated information on previously and newly improved drugs, including side effects, safety risks and steps that can be taken to minimize them. Separate information sheets also will be provided for healthcare professionals and patients.

“Our goal is to prepare the agency for these new demands by improving the way we monitor and respond to possible adverse health consequences that may arise regarding drugs that have been approved for sale to U.S. consumers,“ Crawford said in a statement.

Schultz said there is “always room for improvement,“ but added that FDA staff from every department are concerned with safety.

“It has been targeted at drugs so far, but the truth of the matter is that you could apply it to all medical products,“ he said. “The question is whether you believe that the people who approve products don't care about safety. I have a hard time with that contention. If you believe that, we need a housecleaning and we need a whole new system.

“I think that people within the agency, both on the pre-approval side and the post-market side, care about safety, care about effectiveness, care about getting new products and new technologies to market and come to work every day and try to balance those things.“

Crawford's nomination is subject to congressional approval. While most expect that approval to come quickly, he will likely have to field some tough questions from lawmakers.

Sen. Edward Kennedy (D-Massachusetts), ranking member of the Health, Education, Labor and Pensions Committee, said, for instance, that the current controversies concerning drug approvals came while Crawford was acting commissioner, and so “it will be important for him to lay out to Congress and the American public his specific plans to ensure the safety of our prescription drugs as well as our food supply.“

Crawford received his doctor of veterinary medicine degree from Auburn University (Auburn, Alabama) and a PhD in pharmacology from the University of Georgia (Athens). He has served as administrator of the Agriculture Department's Food Safety and Inspection Service and as an adviser to the World Health Organization (Geneva, Switzerland).

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