Healthy Skepticism Library item: 897

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Publication type: news

Associated Press.
Bush FDA Choice Rattles Advocacy Groups
The New York Times 2005 Mar 18

Full text:

President Bush’s nominee to head the Food and Drug Administration sidestepped allegations from Senate Democrats that something was awry at the agency, but he promised he would improve its drug safety reviews.
Lester Crawford, acting FDA commissioner and Bush’s choice to become commissioner, spoke Thursday at his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions. Several Democrats, citing the recall of the painkiller Vioxx last September and the flu vaccine shortage, asked him to acknowledge that the agency had problems.

``I’m trying to detect whether this is going to be business as usual out of the FDA or whether you’re setting up kind some of system to flag these issues,’‘ said Sen. Edward Kennedy, D-Mass. ``Personally, there has to be recognition that there is a serious problem.’‘

Crawford, who has been acting or deputy FDA commissioner for the past three years, did not accept the assertion that the FDA failed to live up to its mandate. He also rejected the charge that the agency’s image has suffered in the past year.
``I don’t think we’ve been tarnished,’‘ he said, but then added: ``I promise to you to do everything in my power to stem the tide and do the right thing.’‘

Crawford said he would institute a drug safety board that would advise the agency on issues involving drugs already approved for the market. The board’s deliberations would be public. He also said he also wanted decision-making within the agency to be more transparent.
``It is true that within the culture of the FDA there is a lot of give-and-take on these decisions based on science,’‘ he said. ``We want to honor that, and also to report the minority’s’‘ view.

The FDA regulates about $1 trillion worth of products a year and is charged with ensuring the safety and effectiveness of all drugs, medical devices, animal drugs and feed.
Sen. Jeff Sessions, R-Ala., defended 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.
``Your challenge is to identify in advance what would work, what would not work, and make those decisions that are best’‘ Sessions said.

Crawford, elevated to acting FDA director a year ago, said he’s committed to addressing concerns about the safety of medical products as well as food.
``I remain focused on bioterrorism and minimizing the threat of terrorist attack both through heightened food security and through the development of new medical countermeasures,’‘ he said.

Three consumer groups criticized the nomination in a joint letter to the committee. They contended the FDA’s ``high profile missteps and failure to take timely action’‘ in protecting the public against unsafe prescription drugs raise questions about 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 about Vioxx.
Before Merck, the manufacturer, withdrew the drug last September, an FDA scientist had found an increased risk of heart attack and strokes in patients taking the pain killer. Three weeks before Merck pulled the drug, the agency had approved it for use by children.

Democrats asked Crawford to update them on the status of an oral contraceptive application before they vote on his confirmation. 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. They said the agency has taken too long to review the application.

Crawford said the application was complex and unique, but declined to be more specific in public. He offered to discuss the issue privately with senators. He also said he expected a decision in weeks.