- The Washington Times - Thursday, March 17, 2005

ASSOCIATED PRESS

President Bush’s nominee to oversee the Food and Drug Administration rejected assertions by Senate Democrats yesterday that the agency has failed to adequately monitor prescription drug safety. But he promised to create an independent board to help the agency track drugs after they have been approved.

“I don’t think we’ve been tarnished,” said Lester Crawford, who has been acting or deputy FDA commissioner for the past three years. “[But] I promise to you to do everything in my power to stem the tide and do the right thing.”

Mr. Crawford spoke at a confirmation hearing before the Senate Health, Education, Labor and Pensions Committee. Committee Republicans are backing the nomination, but Democrats have adopted a wait-and-see attitude. A vote is likely next month.

Democrats said they want Mr. Crawford to update them on the status of an oral contraceptive application. The drug — Plan B oral contraceptive — is available with a prescription, but some senators say it should be available over the counter, as recommended by an FDA advisory committee.

The FDA regulates about $1 trillion worth of products per year and is charged with ensuring the safety and effectiveness of all drugs, medical devices, animal drugs and feed.

The agency has been under fire because of its handling of Vioxx, a painkiller that New Jersey drug manufacturer Merck & Co. pulled from the market in September. Lawmakers also criticized the agency for failing to inspect a manufacturing plant in Britain where conditions led to the flu vaccine shortage.

“Disturbing allegations have been raised that FDA has prevented open scientific discussion of important drug-safety issues, has disregarded science that conflicts with ideology, and has retaliated against whistleblowers,” said Sen. Edward M. Kennedy, Massachusetts Democrat.

Sen. Jeff Sessions, Alabama Republican, defended Mr. Crawford, saying he has a difficult balancing act: If the agency waits too long to approve a drug, thousands of lives can be put at risk, but if it acts too quickly, the same result is possible.

Mr. Crawford, elevated to acting FDA director a year ago, said he is “committed to addressing existing concerns regarding postmarket safety of FDA-regulated products, both in medical products and food.”

Three consumer groups, in a joint letter to the committee, criticized the nomination. They asserted that the FDA’s “high profile missteps and failure to take timely action” in protecting the public against unsafe prescription drugs raise questions about Mr. Crawford’s “leadership, his ability to manage interagency conflicts and willingness to act in the best interest of consumers.”

The groups — Consumers Union, Consumer Federation of America and the U.S. Public Interest Research Group — focused on the FDA’s response to concerns raised about Vioxx.

Before Merck withdrew the drug, an FDA scientist had found an increased risk of heart attacks and strokes in patients taking the painkiller.

Three weeks before Merck pulled the drug, the agency had approved it for use by children.

The Pharmaceutical Research and Manufacturers of America is backing Mr. Crawford’s nomination.

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