Washington Editor

WASHINGTON - It's over: Lester Crawford is the FDA's official commissioner, finally.

He received Senate approval late Monday with 78 votes cast in his favor. And with a lengthy five-month confirmation process in the rearview mirror, some outside observers expect the 67-year-old to move forward on a number of seemingly stalled issues given his new authority.

"After all the posturing and all the delays, it's really about time that Les got confirmed," said Peter Pitts, a senior fellow for health care studies at the Pacific Research Institute in San Francisco. "I think this is going to signal the FDA's ability to get back to business and to make tough decisions expeditiously and move forward on an agenda."

Pitts, who worked at the agency as an associate commissioner until a year ago, said he expected Crawford to lead a movement to further revamp post-approval drug safety surveillance, an issue that came into the spotlight last year following fatality reports linked to Vioxx (rofecoxib, from Merck & Co. Inc.) and other pain drugs of the same class, without compromising risk-benefit analyses related to efficacy.

"We need a strong leader at the FDA, and one who has a mandate to act," Sen. Michael Enzi (R-Wyo.), a longtime champion for Crawford, said in a prepared statement. "Today's vote gives this nominee a mandate that flows directly from the act of senate confirmation."

Pitts added that he expected Crawford to seek proper funding to aggressively pursue the agency's Critical Path initiatives and also address matters related to follow-on biological drugs.

"These are all things that have been pushed to a turned-off backburner prior to him being confirmed commissioner," Pitts said. "He simply couldn't address those types of issues [as acting commissioner]. I think you'll see him move away from a drift toward ambiguity and [instead] toward more of a proactive predictability."

Still, opponents of Crawford don't see things that way. For months, many have used the safety issue to charge him with leadership failings. From that blame, a bill has surfaced from Sens. Chuck Grassley (R-Iowa) and Chris Dodd (D-Conn.) to establish a drug safety office independent of the FDA. On the Senate floor, Grassley said the agency "is plagued by structural, personnel, cultural and scientific problems," and later added that "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."

But Pitts noted that Sens. Edward Kennedy (D-Mass.), Orrin Hatch (R-Utah) and Enzi "triple-teamed" Grassley on issues related to FDA authorities and the ability of an acting commissioner to follow them up compared to a permanent commissioner. Enzi serves as the chairman of the Senate Committee on Health, Education, Labor and Pensions, which oversees the FDA, and Kennedy is its ranking member. Both voiced strong support for Crawford at last month's committee approval to send the matter to the Senate floor. (See BioWorld Today, June 16, 2005.)

"I think 78 votes, in the face of all the controversy, is an extraordinary vote of confidence," Pitts said. "And hopefully, that puts to bed some of the issues that are in the Grassley-Dodd bill, for example."

Grassley was among 16 senators who voted against Crawford, and another six abstained. Also among the negative voters were Sens. Hillary Clinton (D-N.Y.) and Patty Murray (D-Wash.), who opposed Crawford because of their belief that he has stymied the over-the-counter approval of the Plan B contraceptive product. In addition to that vocal outcry, his nomination generated other controversy. During an initial confirmation hearing several months ago, he was grilled on flu vaccine supply concerns and drug reimportation, as well as on product safety. Later, he was anonymously accused of an extramarital affair with an unnamed colleague, a charge that eventually fizzled. (See BioWorld Today, March 19, 2005, and April 18, 2005.)

But in the end, while such opposition delayed the confirmation process, it did not derail it.

"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," Enzi added. "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."

Crawford, who has a lengthy background at the FDA, received President George Bush's nomination early this year. He previously served as its deputy commissioner and as its administrator of the food safety and inspection service. The FDA had been without a permanent commissioner since Mark McClellan left more than a year ago to serve as administrator of the Centers for Medicare & Medicaid Services. (See BioWorld Today, Feb. 23, 2004, and Feb. 16, 2005.)

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