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T he fourth iteration of the 1992 law that allows the U.S. Food and Drug Administration to levy user fees on drug companies contains several reforms that could create a major change in how the agency monitors the safety of new drugs after they enter the market. Lawmakers are using reauthorization of the Prescription Drug User Fee Act (PDUFA) to overhaul the agency's authorities and responsibilities for ensuring drug safety. The legislation would allow the FDA to collect $393 million in fees annually from the industry starting in 2008. That is up from $305 million this year and includes another $30 million to fund the agency's postmarket-ing drug safety programs. The bill passed the Senate on May 9. A companion bill has been introduced in the House. " The resources and additional staffing made possible by the fees charged by the FDA have enabled the agency to review new medicines more efficiently , while maintaining its stringent safety and effi cacy standards, " said Billy Tauzin, president of Pharmaceutical Research and Manufacturers of America, the drug industry trade group. " The significant increases in user fees will provide the FDA the resources necessary to improve and modernize its already strong drug safety monitoring system. " According to FDA recommendations to Congress, higher user fees will enable the agency to hire 82 new employees devoted to postapproval safety efforts. However, the bill passed by the Senate, in a 93 – 1 vote, actually contains an even bigger increase in user fees than the FDA requested. In addition to increasing user fees, the Senate's measure would require the FDA to modernize its postmarketing surveillance procedures and allow the agency to levy fi nes against drug companies for misleading direct-to-consumer advertising. " This is going to be the biggest set of changes in postmarket drug regulation since at least 1962, " Mark McClellan, M.D., former director of the FDA and now a fellow at the American Enterprise Institute, said at a recent forum on drug safety. " FDA will be doing no less than entering a new era of postmarket drug regulation. " Many of these reforms have come about in light of high profi le safety problems, such as the heart risks associated with cyclooxygen-ase 2 (COX2) inhibitors that were not identifi ed until after the drugs had been widely prescribed. The current system relies on physicians or patients to voluntarily report …

FDA User Fee Law Poised for Passage in Congress but Not Without Stirring Up Controversy