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FDA nominee says he's open to changes at embattled agency

WASHINGTON—Lester Crawford, the Bush administration's nominee to head the Food and Drug Administration, assured lawmakers Thursday that he'd consider numerous changes to the troubled regulatory agency, including making its Office of Drug Safety independent of the division that now manages it.

In a confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions, Crawford also defended the agency's delay in deciding whether to approve the emergency contraceptive, Plan B, for over-the-counter sale. He said he'd support more tests to determine the effects of prescription drugs on children and would back public disclosure of clinical drug-trial results.

All these stands are responses to sharp criticism of the FDA, criticism redoubled in the latest issue of The New England Journal of Medicine, which editorializes that the agency has become "timid and toothless." FDA employees operate, the editorial continues, in "an atmosphere that stifles debate and discourages some employees from expressing scientific concerns about drugs."

One big bone of contention is that the same FDA division manages the Office of New Drugs, which approves them for sale, and the Office of Drug Safety, which looks for health problems in drugs that have already been approved.

Critics say this structure makes the division's top officials reluctant to admit health problems that drug-safety analysts identify. The critics' favorite case in point is Vioxx, the painkiller linked to thousands of deaths from heart disease and stroke. Drug safety officials were concerned about those side effects in 2000, but the FDA sought only to stiffen the warning on the product. Merck yanked the drug last year before the FDA ever moved against it.

Crawford told lawmakers Thursday that the agency plans to create a new drug-safety oversight board composed of FDA and outside experts who'd debate and resolve those conflicts. But he said he'd also entertain proposals to make the Office of Drug Safety a separate entity.

"An independent office of drug safety is something I'm certainly open to discuss," Crawford said. Sens. Charles Grassley, R-Iowa, and Christopher Dodd, D-Conn., are crafting legislation to establish an independent drug-safety office.

Committee Chairman Michael Enzi, R-Wyo., said the panel had received 100 letters of support for Crawford and only one voicing criticism. That was a joint letter from three consumer-watchdog groups: Consumers Union, Consumer Federation of America and U.S. Public Interest Research Group. The groups claimed Crawford hasn't owned up to the agency's shortcomings in the face of strong criticism.

"Though he claims to have a bold vision for the FDA, the question is whether or not Dr. Crawford is committed to achieving substantive rather than symbolic drug safety reform," the joint letter said.

Among his supporters is PhRMA, the drug industry's powerful trade association.

"Dr. Crawford knows the agency and he knows it well. He responds to concerns and crises quickly and with quiet efficiency," PhRMA spokesman Jeff Trewhitt said.

Crawford assured lawmakers that drug safety would be his top concern and said he was committed to beefing up staff and funding for drug safety, which he termed "the one thing we are vulnerable" on.

A veterinarian by training, Crawford, 67, is in his second stint as acting FDA commissioner after serving as deputy commissioner from 2002 to 2004. The former chair of the physiology and pharmacology department at the University of Georgia, he also served as administrator of the Food Safety and Inspection Service at the U.S. Department of Agriculture from 1987 to 1991.

Crawford sparred Thursday with female Democratic senators, who are disturbed by the agency's failure to approve nonprescription sales of the so-called "morning after" contraceptive, Plan B, despite an FDA advisory panel's 24-3 endorsement of it.

Sen. Hillary Rodham Clinton, D-N.Y., said the FDA's inaction on Plan B, made by Barr Pharmaceuticals Inc., was the result of "political interference in a scientific process" by moral conservatives who'd argued that the drug encouraged premarital sex and approximated abortion.

Crawford denied any political motive. He said the delay was the result of a complicated and unique application. He wouldn't describe those complications during testimony, but agreed to do so in a private meeting with Clinton, Sens. Barbara Mikulski, D-Md., Patty Murray, D-Wash., and other committee members.

Barr wants to sell Plan B without a prescription to girls and women 16 and older, while maintaining the prescription status for girls 15 and younger.

The committee is expected to vote on Crawford's nomination in April.


(c) 2005, Knight Ridder/Tribune Information Services.

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