Bush picks acting FDA head to take over as agency chief

Democrats oppose von Eschenbach over contraceptive's lack of availability

March 16, 2006|By JONATHAN D. ROCKOFF | JONATHAN D. ROCKOFF,SUN REPORTER

WASHINGTON -- President Bush nominated Dr. Andrew C. von Eschenbach, acting chief of the Food and Drug Administration, to lead the agency, but Democrats immediately moved to block the choice because of the administration's refusal to approve over-the-counter sales of the "morning after" emergency contraceptive pill.

With the long-expected selection, Bush turned to a family friend who, in a little more than five months in the interim job, passed the administration's key tests of avoiding controversy and proving his loyalty.

"FDA needs permanent leadership to spur more innovation, improve drug safety and help life-saving drugs reach patients faster. Andy understands these needs and will provide leadership to get the job done," Health and Human Services Secretary Michael O. Leavitt said in a statement.

The choice was quickly opposed by Democratic Sens. Patty Murray and Hillary Rodham Clinton, who vowed to block the nomination until the FDA decides whether to sell the "morning after" emergency contraceptive pill to women 17 and older without a prescription.

Murray, of Washington, and Clinton, of New York, held up the confirmation of the previous commissioner, Dr. Lester M. Crawford, until they could elicit a promise that the agency would act on the Plan B request. But after his confirmation, Crawford further delayed a decision, then abruptly resigned in September.

"For more than two years, the FDA has dragged its feet on making a decision, putting ideology over science. It is past time for the FDA to stop dragging its heels," the Democratic senators said in a statement.

Other members of Congress, industry representatives and patient groups had complained to the White House about the absence of a confirmed FDA chief. They said the void diminished the agency's ability to undertake major reforms that would improve drug safety and speed up the approval of new drugs.

They urged the administration and the Senate to resolve the Plan B issue so that the FDA would have a permanent head.

"There has to be a willingness to compromise on issues like that - you just have to thread the needle and get through it," James Greenwood, president of the Biotechnology Industry Organization, said in an interview. He praised von Eschenbach as an "excellent choice."

Democratic Sen. Barbara A. Mikulski of Maryland expressed relief that the FDA was closer to having a permanent chief. She also said she was pleased that von Eschenbach has experience working in a large federal agency.

Mikulski said she plans to meet with von Eschenbach soon and hear his views on Plan B and other pressing agency issues. "I have an open mind," she said.

A urologic surgeon by training and a cancer survivor, von Eschenbach ran the University of Texas's M.D. Anderson Cancer Center and was active in cancer activism circles before coming to Washington.

Bush appointed him in 2002 to run the National Cancer Institute, which funds much of the cancer research in the country. With the nomination, von Eschenbach will relinquish that post, said Erin Healy, a White House spokeswoman. She said a temporary replacement has not been picked.

As acting commissioner, von Eschenbach has signaled the agenda he would pursue as a permanent chief. He has said that drastic scientific advances warrant accelerated drug reviews and encourage the development of treatments tailored to specific patients.

"We've changed the world before: put a man on the moon, split the atom. Why not now? Why not this? Why not health care?" he told an industry group this month.

The FDA is responsible for the safety of the drug and food supply, helping guard against bioterrorism and playing a role in protecting cattle from mad cow disease. All told, it oversees products whose sales constitute a quarter of the American economy.

Given the agency's wide-ranging authority, nominees for FDA commissioner are scrutinized by interest groups and Congress. The scrutiny is likely to be even more intense this time, because the agency's integrity and effectiveness have been questioned after deaths of patients using certain antidepressants, painkillers and implanted heart defibrillators.

Dr. Georges C. Benjamin, executive director of the American Public Health Association, said von Eschenbach would have to expand his focus beyond cancer research to pressing public health issues, such as developing an adequate supply of bird flu vaccine and responding to imports of cheap drugs from Canada. But von Eschenbach, Benjamin said, possessed the management skills and scientific expertise to run the agency.

While leading the cancer institute, von Eschenbach was scorned by many scientists for embracing what they said was the unrealistic goal of eliminating "death and suffering due to cancer by 2015" and introducing religion into scientific proceedings.

During a 2002 presentation, one of his slides said, "We live in a country blessed by God."

"What he practiced at NCI can be described as faith-based science: If we all believe it, we can achieve it," Kirsten Boyd Goldberg, editor and publisher of the Cancer Letter, a newsletter critical of von Eschenbach, said in an e-mail.

She assailed von Eschenbach's ideas for speeding drug reviews, saying patients might wind up exposed to harmful drugs, because they weren't adequately tested before doctors prescribed them. "You could cause deaths - and national scandals," she said.

Jonathan.rockoff@baltsun.com

Sun reporter Gwyneth K. Shaw contributed to this article.

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