As the FDA's user-fee system comes up for renewal in 2007, "a number of lawmakers, consumer advocates and some FDA staff now believe the ... system was a bad deal -- one that has compromised the agency's independence by giving the corporations it regulates too much say over decisions and how the money is spent," the Newark Star-Ledger reports (Cohen, Newark Star-Ledger, 10/1). Under the 1992 Prescription Drug User Fee Act, pharmaceutical companies agreed to pay fees to FDA, and in return the agency agreed to aim to review drugs in 12 months or less. The companies pay fees when they file drug applications, and they also pay fees based on the number of manufacturing facilities they operate and the number of products they sell in the U.S. FDA officials and drug industry representatives are in negotiations over the system's renewal, which must be approved by Congress (Kaiser Daily Health Policy Report, 9/1). According to the Star-Ledger, the system has "worked, with FDA more than doubling its staff for new drug review and cutting approval times in half with use of the steadily growing fees that now account for more than 50% of the agency's spending on review of new drug applications." However, an Institute of Medicine report released last month finds the system reinforces the perception that "powerful industry interests control or strongly influence the regulatory agency's decision making," adding that the system "creates a sense of obligation to please on the part of the agency." The report also says that user fees have created a "troubling resource imbalance," leading the agency to focus more on new drug approvals than postmarket safety.

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Rep. Maurice Hinchey (D-N.Y.), who sponsored a bill that would revise the user-fee system, said, "The way the user fees have been constructed has really corrupted the process of oversight by the FDA and broken down the arms-length relationship that should exist between the regulator and the regulated." FDA spokesperson Susan Bro said, "The decisions that are made are based on science and potential clinical benefit," adding, "At the end of the day, I believe the medical and scientific staff will say their goal is to advance public health and protect the health of the American public." Alan Goldhammer, an associate vice president of the Pharmaceutical Research and Manufacturers of America, said, "The goal has been to give the agency the necessary resources to do their work and render decisions, not tell them how to do that work or how they should arrive at decisions. That would be something we would never entertain doing" (Newark Star-Ledger, 10/1).