Diagnostics & Imaging Week Washington Editor

WASHINGTON — After months of political wrangling, the Senate voted late Monday to confirm Lester Crawford as FDA commissioner.

The confirmation passed handily with a vote of 78-16.

The 67-year-old Crawford, who has served as acting commissioner since Mark McClellan left the FDA more than a year ago to head the Centers for Medicare & Medicaid Services (Baltimore), was nominated by President George Bush in February.

Since then, a series of political roadblocks — and a little scandal — conspired to delay Crawford's move from "acting" to official head of the agency.

There were allegations that Crawford improperly promoted an employee with whom he had an affair, an investigation then clearing the nominee of those charges.

Some lawmakers also pointed to Crawford as a symbol of a system that needs to be revamped, citing questions about FDA post-approval surveillance of drugs and devices, drug safety monitoring, alleged mismanagement of flu vaccine supplies and the status of an application to make the Plan B morning-after contraception available over the counter.

Democratic Sens. Patty Murray (Washington) and Hillary Clinton (New York) had vowed to block the full Senate vote until the FDA ruled on whether the morning-after pill could be sold without a prescription. Murray and Clinton agreed to lift their hold last week following assurances from the FDA that it would issue a decision on Plan B by the beginning of September.

Many Senators — including Edward Kennedy (D-Massachusetts), ranking Democrat on the Senate's health committee and one of Capitol Hill's most widely recognized healthcare hawks — said they believed the need for permanent leadership at the agency made it important for the process to move forward. And they want Crawford to tackle the change necessary at FDA, unencumbered by his "acting" status.

"With a commissioner in place, we can work more effectively on the key issues facing the agency, from how FDA monitors drug safety, to ways to address flu vaccine shortages, to how it handles conflicts of interest on its advisory committees, and how it has acted on Plan B," Kennedy said on the Senate floor.

"While I respected the right of my colleagues to disagree with a president's choice, in the end, I believe we have made the right decision to promote Dr. Crawford," Sen. Mike Enzi (R-Wyoming), chairman of the health committee, said in a statement. "He has a long and distinguished history of leadership and public service, and I look forward to his continued work in promoting and protecting the public health."

Enzi added that the Senate's vote provided Crawford with "a mandate to act."

Breaking ranks with most Republicans, Senate Finance Committee Chairman Charles Grassley (Iowa), who has held hearings about FDA safety issues, was unyielding in his criticism of Crawford's appointment.

"It is becoming more and more obvious to me that FDA is plagued by structural, personnel, cultural and scientific problems," Grassley told colleagues on the Senate floor before the vote. "Those problems should be equally obvious to Dr. Crawford. But under the leadership of Dr. Crawford, the FDA appears to be in a state of denial. Over the past 18 months, Dr. Crawford has not stepped up to the plate. I have seen no recognition of the depth and breadth of the problems at the FDA. I have only seen a few short-term Band-Aids."

Despite the debate in committee hearings and on the Senate floor, industry has been steadfast in its support of Crawford.

Stephen Ubl, on his first day as president of the Advanced Medical Technology Association (Washington), said Crawford understands the "unique characteristics" of the device industry and was pleased the FDA now has a permanent leader.

"We have collaborated with him on a broad range of issues over the years designed to ensure timely reviews of innovative medical technologies and effective postmarket surveillance," Ubl said. "He is an individual committed to doing what's in the best interests of the public and patients, and that's good for our industry."

Jim Greenwood, president of the Biotechnology Industry Organization (Washington) and a former Republican representative from Pennsylvania, praised Crawford's leadership of the FDA through "a difficult period" during the last year.

"Dr. Crawford recognizes that the FDA's role as regulatory gatekeeper is pivotal to both fostering innovation and ensuring product safety," he said. "The FDA must be prepared for the innovations emerging from genomics, proteomics, nanotechnology and other biotechnology applications. We're entering an era of personalized medicine and a revolution with the potential to further tame disabling and deadly diseases. A well-funded, effectively managed FDA is essential to bringing those breakthroughs to patients."

Following Crawford's nomination, Dan Schultz, director of the FDA's Center for Devices and Radiological Health, told Diagnostics & Imaging Week that his boss has been "very supportive" of the center's initiatives, including the embattled user fee program.

Crawford told a group of industry leaders at the recent Medical Device Manufacturers Association (Washington) annual meeting that the FDA was open to restructuring the user-fee program. The FDA, lawmakers, and industry groups currently are debating adjustments to the program, and the MDMA issued a statement citing Crawford's "experience and leadership" that will "allow him to deal with the challenges associated with the rapid innovation in the medical technology industry."

Schultz stressed that the Crawford confirmation maintains continuity and will keep the center's programs moving forward without delay. "He has a steady hand; he understands the regulatory process; he understands science; and he understands the political process. I think he is going to do a great job."

Crawford's previous experience includes service as the FDA's deputy commissioner and as its administrator of the food safety and inspection service.

His resume also includes a five-year term as the director of the Center for Food and Nutrition Policy at Georgetown University (Washington) and Virginia Tech (Blacksburg, Virginia), and as an adviser to the United Nations' World Health Organization (Geneva, Switzerland) for almost 20 years.

He received his doctor of veterinary medicine from Auburn University (Auburn, Alabama) in his home state, and a PhD in pharmacology from the University of Georgia (Athens).

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