The Food and Drug Administration will establish a new independent Drug Safety Oversight Board to monitor FDA-approved medicines once they’re on the market and update physicians and patients with emerging information on risks and benefits.
House and Human Services Secretary Mike Leavitt announced the creation of the board during a meeting with FDA employees Tuesday. The agency has been criticized sharply in recent months as reacting too slowly to reports linking the arthritis drug Vioxx and pain drug Celebrex to increased risks of heart attack and stroke.
Leavitt said it’s clear that people want more oversight and openness from the agency.
'New culture of openness'
“They want to know what we know, what we do with information and why we do it,” he said, promising to create “a new culture of openness and enhanced independence.”
The board will recommend what information and updates to put on the government’s Drug Watch, resolve disputes over drug safety issues and oversee the development of a drug safety policy.
It will be composed of FDA employees, medical experts from other HHS agencies and governmental departments, and consult with outside medical experts as well as consumer and patient groups, officials said.
To improve new drug safety information reaching patients and doctors, the board will create a drug safety Web page with emerging information for both previously and newly improved drugs, such as side effects, safety risks and steps that can be taken to minimize them.
One-page information sheets for health care professionals and another for patients also will be made widely available, officials said.
Lester M. Crawford, the acting FDA commissioner who was nominated Monday by President Bush to assume the post permanently, said the agency now “understands that the public expects better and more prompt information.”
Focus on bioterrorism
Newly sworn in himself, Leavitt said last week that he expected the FDA to adopt “an emboldened vision for that agency” to meet 21st-century threats.
Chief among them is bioterrorism. Outgoing HHS Secretary Tommy Thompson said in December that the nation’s food supply is so vulnerable he was surprised terrorists had not yet tainted it, saying, “it is so easy to do.”
The White House on Monday announced Crawford’s nomination to replace Mark McClellan, who left the FDA last March to oversee the agency that runs the Medicaid and Medicare programs.
White House allies say Crawford, 66, is ideal for the job particularly because he has been acting commissioner for nearly a year and has experience monitoring food safety.
But watchdog groups have criticized Crawford’s ties to the food industry, and his record as acting commissioner provides another target. Opponents say, for example, that the FDA reacted too slowly when drugs it had approved, like Vioxx and ephedra, proved dangerous.
The groups urged the Senate on Monday to “vet the vet,” a reference to Crawford’s training as an animal doctor.
“Under Dr. Crawford’s watch, the FDA has failed to protect the public from dangerous prescription drugs, dietary supplements and contaminated animal feed that could carry mad cow disease,” said Janell Mayo Duncan, counsel for Consumers Union, which publishes Consumer Reports.
Senate Democrats took a diplomatic approach.
“As many of these controversies arose while Dr. Crawford was acting commissioner, it will be important for him to lay out to Congress and the American public his specific plans to ensure the safety of our prescription drugs as well as our food supply,” said Sen. Edward Kennedy of Massachusetts, the Senate Health Committee’s lead Democrat.
Industry groups came to his defense.
“Dr. Crawford knows the agency and he knows it well. He responds to concerns and crises quickly and with quiet efficiency,” said Jeff Trewhitt, spokesman for the Pharmaceutical Research and Manufacturers of America.
Crawford has a Ph.D. in pharmacology from the University of Georgia and has served as administrator of the Agriculture Department’s Food Safety and Inspection Service and as an adviser to the United Nations’ World Health Organization.