Washington Editor

WASHINGTON - Every now and then when a drug doesn't win FDA approval, someone in the background can be heard blaming the failure on a lack of leadership at the government agency.

It's true that the FDA hasn't had a full-time commissioner since former President Clinton appointee Jane Henney resigned upon the January 2001 inauguration of President George Bush.

Clearly, Bush has had other issues to deal with, but his failure to appoint someone to run the agency has now reached a point where action needs to be taken, industry officials said.

Carl Feldbaum, president of the Washington-based Biotechnology Industry Organization (BIO), told BioWorld Today that complaints from within the industry have "reached quite a crescendo." As a result, he said, "we are driving this issue so hard with Congress and the administration."

Furthermore, Feldbaum said he and other industry leaders would be "aggressively helpful to the administration in screening names and trying to get a credible, highly qualified candidate."

And just last week, BIO collected the signatures of 100 biotechnology company representatives and attached them to a letter sent to Bush requesting that the administration hasten the process of naming a commissioner.

"The biotechnology industry - and the nation - needs strong leadership from an FDA commissioner with vision and experience in science, medicine and administration," the letter said. "A new commissioner must reverse the trend of increased review times, demonstrate to Congress the need for additional appropriations, lead on bioterrorism issues and insist on quick action to extend the Prescription Drug User Fee Act." (PDUFA III has been approved by both the House and Senate, and is now waiting for Bush's signature.)

Aside from those qualifications, the letter also suggests that the candidate possess "current or past industry experience."

In the last year or so, a number of names have surfaced as possible candidates for the job. Among them, the industry favorite was Michael Astrue, a senior vice president of Transkaryotic Therapeutics Inc. (TKT) in Cambridge, Mass. Astrue withdrew his name from consideration in November and would not discuss his reasons. However, it was reported that Sen. Edward Kennedy (D-Mass.), who chairs the Senate Health, Education, Labor and Pensions Committee, which oversees the FDA, opposed any candidate from the industry and would not even give Astrue a hearing. (See BioWorld Today, Nov. 2, 2001.)

All the while, the agency was being run by Bernard Schwetz, a career FDA official who was serving as acting principal deputy commissioner, that is, until Tommy Thompson, secretary of Health and Human Services, named Lester Crawford Jr. deputy commissioner in February. (See BioWorld Today, Feb. 28, 2002.)

The common belief at that time was that Crawford, a veterinarian who most recently served as director of Virginia Tech's Center for Food and Nutrition Policy in Alexandria, would become de facto commissioner.

In fact, in the letter to Bush, the biotechnology CEOs complimented the president on the appointment of Crawford.

But whether Crawford ends up running the agency remains to be seen.

When asked whether he had any insights into particular candidates being considered by the president, BIO's president said no. "I think the door is ajar - hopefully ajar for someone who has experience in drug development from some time in their career," Feldbaum said.

Responding to questions about failing drug applications and reported slowing review times, Feldbaum said, "I think it's a human factor. The reviewers are unwilling to make any major decisions without assurance that the FDA leadership will back them up. And without leadership, there's no such assurance."

Some of the company officials who signed the letter were Michel de Rosen, CEO of ViroPharma Inc., of Exton, Pa.; Dennis Fenton, executive vice president of Amgen Inc., of Thousand Oaks, Calif.; William Haseltine, chairman and CEO of Human Genome Sciences Inc., of Rockville, Md.; and David Pyott, chairman of the board, president and CEO of Allergan Inc., of Irvine, Calif.

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