President Bush’s nominee to run the Food and Drug Administration vowed on Thursday to lead a “transformation” of the agency now under fire for a series of drug safety problems.
Lester Crawford, currently the FDA’s acting commissioner, told Congress the agency was “transforming our culture to one of transparency, collaboration and cutting-edge thinking.”
“I am committed to addressing existing concerns regarding post-market safety of FDA-regulated products, both in medical products and food,” Crawford told the Senate Health, Education, Labor and Pensions Committee.
He also said he would focus on minimizing the threat of a terrorist attack on the nation’s food supply.
Rebuild public trust
Democrats said they wanted assurances that Crawford could rebuild public trust in the agency after a string of serious side effects were linked to FDA-approved drugs.
“These drug safety controversies occurred during your tenure as acting commissioner of the FDA, and quite frankly, I was disappointed by your response,” said Sen. Hillary Rodham Clinton, a New York Democrat. “I think the American public lost a great deal of confidence in the ability of the agency to ensure the safety of their medications.”
The FDA regulates a vast array of consumer products, including pharmaceuticals, medical devices, most foods and dietary supplements.
The nomination of Crawford as FDA commissioner must be approved by the Republican-controlled Senate.
Crawford is a veterinarian and food policy expert with a doctorate in pharmacology. He has run the FDA since March 2004, when previous Commissioner Mark McClellan left to head the Centers for Medicare and Medicaid Services.
Crawford also served as acting FDA commissioner from February to November 2002.
Suppressed warnings?
During Crawford’s most recent tenure, the FDA has come under intense criticism. Two agency scientists publicly charged FDA officials with ignoring or suppressing warnings about dangerous drugs.
Merck & Co. Inc.’s withdrawal of its arthritis pill Vioxx last September sparked concern that the agency did not pay enough attention to earlier signs the drug could contribute to heart attacks and strokes.
The FDA also was criticized for taking months to conclude that antidepressant use could raise the risk of suicidal behavior in children and teens.
The agency has responded by announcing creation of a new drug safety board and other measures.
Sen. Michael Enzi, the Wyoming Republican who chairs the Senate health committee, said he was confident Crawford would work with Congress on reforms to bolster drug safety.
“I trust you share our concerns and that you will continue to work with us to evaluate and eventually implement the necessary reforms to the system,” Enzi said.