Diagnostics & Imaging Week Washington Writer

WASHINGTON – With Lester Crawford’s totally unexpected exit from his post as FDA commissioner on Sept. 23 – a mere two months after he received Senate confirmation to permanently head the agency – some of his critics are 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, Grassley has conducted FDA oversight during Crawford’s tenure atop the agency and had frequently criticized what he termed as a “too-cozy relationship with the pharmaceutical industry and an attitude of shielding rather than disclosing information.”

Grassley added: “Now is the time to reform the FDA’s culture.”

The majority of the criticism has been the result of the agency’s handling of pharmaceuticals, though the FDA has experienced significant recent problems on the device side in its handling of implantable cardiac device recalls by Guidant (Indianapolis) as well. But device manufacturers have had few problems with Crawford himself.

Christopher Delporte, director of member relations and communications for the Medical Device Manufacturers Association (Washington), said that the association “enjoyed working with [Dr. Crawford]. We had a good relationship with him and wish him all the best.”

The Advanced Medical Technology Association (AdvaMed; also Washington) issued no statement on the resignation or prospects for future leadership.

Following Crawford’s abrupt leave-taking, President George Bush named Andrew von Eschenbach as acting commissioner. Already the director of the National Cancer Institute (NCI; Bethesda, Maryland), 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, president of the Werner Group consulting firm (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 the Centers for Medicare & Medicaid Services (CMS; Baltimore), and also between CMS and the NCI, Werner told Diagnostics & Imaging Week 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.

Also weighing in positively on von Eschenbach were various associations and trade industry groups.

Jim Greenwood, president and CEO of the Biotechnology Industry Organization (BIO; Washington), said in a statement that von Eschenbach “will be able to provide strong, certain leadership,” adding that the biotech industry needs the FDA to be “credible and predictable.”

A spokesperson at the American Cancer Society (Atlanta) said that the organization has “had a great working relationship” with von Eschenbach and expects that interaction to continue in achieving 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 (Houston). He also was lined up to head the American Cancer Society until the move 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.”

As for the 67-year-old Crawford, his memo that went out late last 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, and previously he had served as a deputy commissioner and as its administrator of the food safety and inspection service. He received Senate confirmation earlier this summer.

But in spite of his history with the agency, the Capitol Hill hearings were considerably bumpy, 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. (Whitehouse Station, New Jersey), which arose during his tenure as acting commissioner.

Another product safety issue swirling about was the pediatric and adolescent use of antidepressants, and he 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. That last issue continues to bubble up with charges that, under Crawford’s watch, the agency has stonewalled on deciding the morning-after pill’s fate.

Other recent safety concerns have arisen more recently concerning oversight of animal feed problems.

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 heavily on such personnel, given his plans to remain at the top spots for both the FDA and NCI.

“He successfully navigated that whole vetting process and finally got confirmed, only to be tripped up by something now,” Werner said.

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