President Bush Signs To Reauthorize Prescription Drug User Fee Act
Prescription Drug User Fee Act
President Bush on Tuesday signed into law a bill (HR 3580) that will expand FDA oversight of prescription drug safety and reauthorize the Prescription Drug User Fee Act, the AP/Long Island Newsday reports (Bridges, AP/Long Island Newsday, 9/27).
Underthe legislation, the user fees that pharmaceutical companies pay FDA toreduce approval times for new medications will increase by about 25% to$400 million annually. The user fees that medical device companies payalso will increase. In addition, the bill includes provisions thataddress prescription drug safety, postmarket studies on newmedications, prescription drug advertisements, clinical trialdisclosures, pediatric trials and conflicts of interest on FDA advisorycommittees (Kaiser Daily Health Policy Report, 9/21).
FDAofficials will complete a review of the 156-page law -- which includesabout 200 specific provisions, many with timelines -- before theydecide on a plan for implementation. Implementation of some of theprovisions in the law might require FDA to draft new regulations orguidelines, a process that can take years to complete, according toRandall Lutter, deputy commissioner for policy at the agency.
Sen. Edward Kennedy (D-Mass.) said of the law, "It strengthens safetyrules for the wave of new miracle drugs coming on the market thatAmericans count on to protect their health."
FDA CommissionerAndrew von Eschenbach said, "It really represents an important additionto the FDA's authority." Janet Woodcock, deputy commissioner and chiefmedical officer at FDA, said, "We welcome the ability to really engagein how those products perform once they are out on the market."
Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America,said, "The increased fees will allow the agency to expand drug safetymonitoring, hire additional staff for postmarket surveillance andmodernize its information technology systems" (AP/Long Island Newsday, 9/27).
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