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Bush Nominates FDA Acting Chief To Be Permanent Head of Agency

By Marc Kaufman
Washington Post Staff Writer
Tuesday, February 15, 2005; Page A15

Lester M. Crawford, who has been running the Food and Drug Administration as acting commissioner during a period when the agency was repeatedly buffeted by drug safety controversies and unprecedented internal dissent, was chosen yesterday by President Bush to be permanent head of the agency.

The nomination was applauded by pharmaceutical industry trade organizations, which said Crawford brings deep experience and a cool head to the job.

Lester M. Crawford, the acting FDA commissioner, has run the agency in a time of contention over drug safety.

But some public-interest health groups, as well as some members of Congress, voiced deep reservations. They said Crawford has not aggressively attacked drug safety problems, has allowed some internal dissent to be stifled and has shown a tendency to buckle in the face of political pressure.

"In some cases the FDA has disregarded important concerns and warnings from its own best scientists," said Sen. Charles E. Grassley (R-Iowa), who held hearings last year that elicited intensely critical testimony. "During Senate consideration of Dr. Crawford's nomination, I want to hear statements that prove he understands why public confidence has been shaken and a commitment to enacting reforms inside the FDA to keep the agency focused on public health and safety." The appointment must be confirmed by the Senate.

Crawford, who has served as acting commissioner or deputy commissioner for almost three years under Bush, was trained in veterinary medicine and pharmacology and has specialized in food safety issues for the agency and in academic settings. For almost 20 years, he also served as an adviser to the United Nation's World Health Organization.

At Tommy G. Thompson's farewell from the Department of Health and Human Services, the departing secretary said he was greatly concerned about the vulnerability of the nation's food supply to terrorism. New Secretary Mike Leavitt has said he intends to concentrate on that issue, and Crawford is seen as an expert in the field.

Crawford, 66, has a low-key speaking style and has led the agency as acting director with far less flair than Mark B. McClellan, who was commissioner for 17 months between Crawford's two tenures as acting commissioner. McLellan left to head the Centers for Medicare and Medicaid Services.

In a statement, a drug industry trade group, Pharmaceutical Research and Manufacturers of America, praised Crawford as a man who "responds to concerns and crises quickly and with quiet efficiency."

"When concerns were expressed a couple of years ago about manufacturing practice standards, he ordered an assessment of the standards and put in place thoughtful reforms," the group said. "When concerns were expressed late last year about drug safety, he responded immediately and constructively by asking the prestigious Institute of Medicine to thoroughly investigate the drug safety system and make recommendations."

But others did not give Crawford's performance the same kind reviews. During Grassley's hearing last fall, scheduled after Merck & Co. suddenly withdrew its blockbuster drug Vioxx because of safety concerns, FDA safety officer and whistle-blower David Graham testified that the agency is unable to protect the public from dangerous drugs. Graham also said the agency's leaders had silenced dissent.

Several public-interest groups and officials said they were concerned about the agency's slow response to recent safety concerns about Vioxx and other COX-2 inhibitors, widespread prescribing of antidepressants to children, and dietary supplements such as ephedra. The agency has also been accused of making decisions that appeared to be based on politics rather than science.

In particular, the agency came under sharp criticism for its decision last year to reject nonprescription sales of the emergency contraceptive Plan B, even after the FDA staff and 23 of 27 members of an expert advisory panel strongly supported the application. The agency postponed a decision on revised application earlier this year, leading critics to charge the agency was yielding to social conservatives who oppose the move.

Kirsten Moore, president of the Reproductive Health Technologies Project, a public-interest group that supported over-the-counter sale of Plan B, said Crawford has not been forceful in addressing a growing list of controversies.

"We need a strong commissioner who is committed to making evidence-based decisions that are in the interest of public health," Moore said. "Dr. Crawford's track record strongly suggests he is not that person."

Sen. Edward M. Kennedy (D-Mass.) also voiced reservations, although he said he was pleased that the agency was getting a permanent commissioner -- which it has had for only about one-third of Bush's term.

Despite the setbacks suffered by the drug industry in recent months as the safety of several blockbuster drugs was called into question, sales continued to grow in 2004, the health statistics company IMS Health reported yesterday.

In its recap of 2004 trends, the company said that the number of prescriptions dispensed grew by 3.2 percent, while sales increased by 8.3 percent to $235.4 billion. The fastest growth was seen in biotech drug and biologics, which saw a 17 percent sales increase.

The Biotechnology Industry Organization (BIO), which represents biotech companies, warmly welcomed Crawford's appointment. Saying he has done a "remarkable job" as acting commissioner, BIO President James Greenwood added, "This nomination sends the right signal to patients and consumers, that there will be vision and leadership in the agency."

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