Proposal to Give FDA More Muscle Gets Mixed Reviews

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Dr. A. Mark Fendrick, a frequent critic of the FDA, is a professor of health management and policy at the University of Michigan School of Public Health. He said: "The expanded authority of the FDA to create an active surveillance program for drugs in the marketplace creates an important added layer of safety to detect rare or unexpected adverse events that are simply not detectable in the pre-marketing approval process."

"This provision, if adequately funded and implemented, should help restore confidence in the agency and, more importantly, allow the benefits and risks of a drug to be updated over years of use -- as opposed to our current system that gets its safety information almost exclusively from research studies that are neither performed in real-world settings nor in real-world patients," Fendrick added.

Dr. Steve E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic and another frequent FDA critic, believes the bill contains important provisions but does have some flaws.

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"My concern is that I'm beginning to believe that we need to separate post-marketing surveillance from the Office of New Drugs and the bill doesn't do that," Nissen said.

"I've read that the maximum fine was $2 million," he said. "That is not even pocket change. When you have a drug, say, like Vioxx that's bringing in $4 billion to $5 billion a year, a $2 million fine is not even a rounding error."

Nissen emphasized that he supported the Senate bill and, in fact, had worked with senators on drafting it. "It's a good bill," he said.

But other experts view the proposed changes in the Senate bill as a continuation of a drug-safety system that is fundamentally flawed and likely to stay that way.

"The larger problem is that the user fees themselves are an inappropriate way to fund the agency," said Dr. Peter Lurie, deputy director of the Health Research Group at the nonpartisan advocacy organization Public Citizen. "We can't have an agency that is dependent for 50 percent of funds for its reviewing functions from the industry it's reviewing. Why it is that we have to put ourselves in this untenable conflict of interest for a function so critical as drug review I just don't understand."

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