Proposal to Give FDA More Muscle Gets Mixed Reviews

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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.

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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.

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