By Kim Coghill

Washington Editor

WASHINGTON ¿ Although White House staffers are being tight-lipped about who President Bush will appoint as FDA commissioner, other industry watchers who began speculating last week are guessing the same name.

Speculation really began to heat up late last week when The Boston Globe reported that Michael Astrue, senior vice president of administration and general counsel for Cambridge, Mass.-based Transkaryotic Therapeutics Inc. and chair of the Massachusetts Biotechnology Council, is one of the top candidates. His competition is reportedly Eve Slater, a senior vice president at Whitehouse Station, N.J.-based Merck and Co., and Lynn Drake, a dermatologist with ties to the Republican Party. Richard Pazdur, from the FDA¿s cancer division, is another candidate.

The Wall Street Journal reported Friday that Astrue is the top candidate.

And Lee Rawls, vice president for government relations at Washington-based Biotechnology Industry Organization, said, ¿Astrue is considered the consensus leader and someone BIO would support, strongly.¿

An announcement is expected early next month.

The new commissioner would replace Jane Henney, former President Bill Clinton¿s appointee, who resigned after Bush¿s inauguration. Henney was in charge last fall when the controversial abortion pill, known as RU-486, was approved.

None of the candidates could be reached for comment Friday, but Stephen Mulloney, director of government relations and communications with the Massachusetts Biotechnology Council, confirmed that Astrue is on the short list.

¿Mike has confirmed that he was approached by Bush administration officials who wanted to find out if he was interested in the position,¿ Mulloney said. ¿It would be an honor to have someone from Massachusetts leading the FDA. Mike is a highly intelligent, highly motivated individual who will bring great skill and limitless compassion to this enormously important position. Mike is a valued member of the state¿s biomedical community and has contributed to its strength and growth.¿

Industry Wants Decision Soon

Regardless of who is selected, some insiders around Washington are saying the choice needs to be made pretty quickly.

¿There¿s no political leadership at the FDA. Many of the employees are left without direction and some key decisions are not being made because employees do not want to be second-guessed,¿ Bruce Mackler, an attorney in Washington, told BioWorld Today.

And Carl Feldbaum, BIO¿s president, earlier this year said he had urged the administration to install a new FDA commissioner soon. ¿There¿s a sense of displeasure with [the agency¿s] performance. I don¿t think it¿s necessarily a conscious slowdown.¿

Instead, he said in February, there are a number of factors, including morale problems at the agency, some pay related and other leadership related. Right now, [the agency] has no leader, and this won¿t get better until it does.¿

The FDA has essentially been without leadership since Bush was elected last November, and as a result, the agency is in limbo and, according to sources, directors fear making decisions, therefore slowing approvals of new drug applications.

But Janet Woodcock, director of the Center for Drug Evaluation and Research, denies that, saying, ¿We have not slowed down reviews. Our review is reactive and we have no control over what the industry submits to us. If we send them an approvable letter and they take a year to respond, then that is a matter of their priorities and will therefore prolong the time it takes that product to get approved by a whole year. Approval times reflect how long the process took, both the number of cycles and the company time.

¿The longer approval times this year reflect, in part, applications that were submitted years ago, and went through a number of cycles and are not just [receiving a final action].¿

Bush Aides Say He Is Right On Schedule

Although Bush has been criticized in some venues for taking too long to finish up appointments, according to a statement released by the White House, the president isn¿t doing too badly compared to his predecessors.

As of June 15, Bush had nominated 265 individuals for various positions and 132 had been confirmed. At the same point in his administration, Clinton had nominated 214 people and 160 had been confirmed. Ronald Reagan had nominated 258 and 176 had been confirmed.

Ted Kennedy (D-Mass.), chairman of the Senate Health Committee, will lead the confirmation hearing process for the FDA.

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