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Proposal to Give FDA More Muscle Gets Mixed Reviews

Senate bill seeks to improve agency's ability to protect public from dangerous drugs

THURSDAY, May 10, 2007 (HealthDay News) -- A U.S. Senate bill that offers up the prospect of enhanced powers for the U.S. Food and Drug Administration in its dealings with the pharmaceutical industry is drawing both praise and criticism from health experts.

Some believe the bill, approved overwhelmingly in a 93-1 vote Wednesday, would help restore consumer confidence to a regulatory system that has been shaken in recent years by drug recalls and reports of serious health risks to consumers. But others say the proposed changes don't go far enough.

Under terms of the Senate bill, the FDA would be able to mandate changes in drug labels, remove from the market drugs considered dangerous to consumer health, and order more studies of drugs already on the market. The agency would also be required to establish a database of all clinical trials of drugs to make safety issues more transparent.

The Senate bill would also enable the FDA to fine companies up to $2 million if they do not comply with the new system.

One of the biggest changes outlined in the bill would give the FDA the authority to monitor drugs after they have reached the market. In the past, the agency had to negotiate with pharmaceutical companies before labeling changes could be made. It also could only request that a company remove a dangerous drug from the market and generally only had such authority before a drug was approved for use by consumers.

The FDA's image has taken a beating the last few years, starting with the 2004 removal from the market of the arthritis drug Vioxx, which was eventually found to increase the likelihood of heart attack and stroke. Senators said the new bill was an effort to restore Americans' confidence in the FDA's ability to protect consumers. The bill would also meet many recommendations made by the National Academy of Sciences.

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.

"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."

The user fees Lurie referred to are part of the Prescription Drug User Fee Act (PDUFA), passed by Congress in 1992 to establish user fees paid by the drug companies to the FDA to review and vote on new drug applications.

The system of fees established by PDUFA would have expired Sept. 30 without action by Congress. That action came on Wednesday when the Senate voted to give the FDA broader enforcement powers as part of the Food and Drug Administration Revitalization Act.

The House of Representatives is expected to pass its own version of the bill.

The changes in the Senate bill are the culmination of years of mounting concern about drug safety in the United States, and they incorporate many recommendations from the Institute of Medicine.

Some drug manufacturers favor the new provisions.

The Generic Pharmaceutical Association called the Senate bill "a step in the right direction for providing consumers with greater access to safe and affordable generic medicines."

Sen. Edward M. Kennedy, D-Mass., the chief sponsor of the bill, said: "This landmark legislation creates a stronger Food and Drug Administration and sets forth a new and better direction for the safety of drugs we take and the food we eat. Almost half of all Americans take at least one pill a day, so this legislation will make a difference in the life of every American family. From prescription drugs to pacemakers to chemotherapy to the food we eat, the FDA protects the health of hundreds of millions of Americans --- often in ways we barely realize."

Sen. Michael B. Enzi, R-Wyoming, and ranking member of the Senate Health, Education, Labor and Pensions Committee, said: "Right now, the FDA has its hands tied behind its back when it tries to manage the risks of drugs already on the market. This bill will clarify and strengthen the FDA's authority and give it new tools to take measured and appropriate steps to protect the health and safety of Americans when the agency's post-market surveillance signals potential dangers from a drug or therapy."

More information

Learn more about the Prescription Drug User Fee Act at the U.S. Food and Drug Administration.

SOURCES: Peter Lurie, M.D., deputy director, Public Citizen's Health Research Group, Washington, D.C.; A. Mark Fendrick, M.D., professor, internal medicine, University of Michigan School of Medicine, and professor, health management and policy, University of Michigan School of Public Health, Ann Arbor; Steven E. Nissen, M.D., chairman, Department of Cardiovascular Medicine, Cleveland Clinic Foundation, and immediate past president, American College of Cardiology; May 10, 2007, statement, Generic Pharmaceutical Association, Arlington, Va.
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