Washington Editor

WASHINGTON - A surprising departure atop the FDA has Lester Crawford out as commissioner, just two months after he received Senate confirmation to permanently lead the agency, and some of his critics looking toward a fresh course at the government regulatory agency.

"The opportunity to name a new commissioner is a chance to take the agency in a necessary new direction," Sen. Chuck Grassley (R-Iowa) said in a statement. The chairman of the Committee on Finance, he has conducted FDA oversight during Crawford's tenure atop the agency and criticized a "too-cozy relationship with the pharmaceutical industry and an attitude of shielding rather than disclosing information."

"Now is the time to reform the FDA's culture," he added.

Following the abrupt resignation, President Bush named Andrew von Eschenbach acting commissioner. Already the director of the National Cancer Institute (NCI), a position he has said he would maintain, von Eschenbach clearly has the administration's support. But wearing two hats begs a question as to his future atop the FDA: Does his interim appointment reflect a temporary fix or will it become permanent?

"I don't think anybody knows that," said Michael Werner, the president of the Werner Group consulting firm in Washington. "But you have to believe that if he's the FDA commissioner for any reasonable period of time, there will be an acceleration of [multi-agency] initiatives."

Pointing to calls for sharing safety and efficacy data between the FDA and Centers for Medicare & Medicaid Services (CMS), and also between CMS and the NCI, Werner told BioWorld Today that he expects such movements will begin to come together more fluidly. "It's not hard to see that the agencies will start collaborating more and more," he said.

Industry trade associations and patient advocacy groups also weighed in positively on von Eschenbach. Jim Greenwood, the president and CEO of the Biotechnology Industry Organization (BIO) in Washington, said in a statement that the new FDA head "will be able to provide strong, certain leadership," adding that the biotechnology industry needs the FDA to be "credible and predictable." A spokesperson at the American Cancer Society in Atlanta said that the organization has "had a great working relationship" with von Eschenbach and expects that interaction to continue in working toward his stated goals in addressing oncology.

A cancer survivor himself, von Eschenbach assumed the NCI's top post in January 2002 after a lengthy tenure at the University of Texas M. D. Anderson Cancer Center in Houston. He also was lined up to head the American Cancer Society until moving to the NCI.

"He understands from a patient's perspective how FDA needs to make sure that there's a good review process to make sure that safe and effective drugs get on the market," Werner said. "As a scientist and as a patient, he demands respect from everybody."

For the 67-year-old Crawford, his memo that went out late Friday caught many off-guard.

"I think it's surprising in that sense that I don't think anyone saw it coming," Werner noted. "Nobody seems to know a lot of details."

Crawford, who had a long background at the FDA, received President George Bush's nomination to lead the agency on a permanent basis early this year. He previously had been its acting commissioner for a full year before that, prior to which he served as a deputy commissioner and as its administrator of the food safety and inspection service. He received Senate confirmation earlier this summer. (See BioWorld Today, July 20, 2005.)

But in spite of his history with the agency, the Capitol Hill hearings were a bit bumpy at times with criticism hurled his way on a range of issues.

Always at the forefront were questions on drug safety and related concerns that grew in the wake of the market withdrawal of Vioxx (rofecoxib, from Merck & Co. Inc.), which arose during his tenure as acting commissioner. Other product safety issues swirled about the pediatric and adolescent use of antidepressants, and he also was criticized for the FDA's failure to act on an application for over-the-counter use of the prescription-only Plan B contraceptive product. (See BioWorld Today, March 18, 2005.)

That last issue continues to bubble up with charges that the agency has stonewalled on deciding the morning-after pill's fate under Crawford's watch. Other recent safety concerns have arisen more recently on implantable cardiac defibrillators, as well as oversight problems on animal feed.

"He successfully navigated that whole vetting process and finally got confirmed, only to be tripped up by something now," Werner said, "given all that's gone on and the issues that he's had to confront."

Going forward, Werner noted that the future of the FDA's senior staff remains a bit unclear right now, though von Eschenbach is likely to lean on such personnel given his plans to function at both the FDA and NCI.

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