FDA on Thursday proposed a 29% increase in the annual user fees paid to the agency by pharmaceutical companies to improve oversight of prescription drug safety, reduce approval times for new medications and monitor direct-to-consumer television advertisements for treatments, the Newark Star-Ledger reports (Cohen, Newark Star-Ledger, 1/12). Under the 1992 Prescription Drug User Fee Act, pharmaceutical companies agreed to pay user fees in exchange for reviews of new medications in 12 months or less. Pharmaceutical companies pay user fees when they file applications for new medications based on the number of manufacturing facilities that they operate and the number of products that they market in the U.S. The law will expire this year without reauthorization by Congress (Kaiser Daily Health Policy Report, 10/2/06).

Proposal Details
Under the proposal from FDA, pharmaceutical companies in fiscal year 2008 would pay the agency about $393 million in user fees, compared with $305 million in FY 2007. FDA would use about $30 million of the additional funds to improve oversight of prescription drug safety (Wilde Mathews, Wall Street Journal, 1/12). FDA would hire 82 additional experts to examine prescription drug data from health insurers, physicians and pharmaceutical companies to find patterns of safety problems. In addition, FDA would use almost $12 million of the additional funds to cover rent and other costs related to the move to a new facility in Silver Spring, Md. (Ginsberg, Philadelphia Inquirer, 1/12). FDA would use $4 million of the additional funds to purchase technology that would allow pharmaceutical companies to submit applications for new medications electronically (Reuters/Los Angeles Times, 1/12). FDA would use $6.3 million of the additional funds to hire 27 staff members to review DTC television ads for medications before they air. FDA said that the practice would provide pharmaceutical companies with "input on whether or not the advertisements are accurate, balanced and adequately supported, enabling them to address any problems before the advertisements are shown to the public." FDA also would use $4.6 million of the additional funds to hire 20 staff members to advise pharmaceutical companies on improved clinical trial designs and use some of the funds for work with outside researchers to develop "biomarkers" that would help the agency to determine whether medications are safe and effective. FDA will submit the proposal to the House Energy and Commerce Committee and the Senate Health, Education, Labor and Pension Committee for consideration after a public comment period and a public meeting scheduled for Feb. 16 (Reichard, CQ HealthBeat, 1/11).

Comments
Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs, said that the proposal is "going to mean that the FDA will have more resources for doing some of the things it needs to do to improve the drug safety program" (Bloomberg/Chicago Tribune, 1/12). HHS Secretary Mike Leavitt said, "The proposal recommendations would support significant improvements in FDA's ability to monitor and respond to emerging drug safety issues, as well as continuing FDA's commitment to scientific improvements and streamlining the drug approval process" (Pugh, Miami Herald, 1/11). Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America, said that the proposal calls for "comprehensive improvements in all areas that are essential to timely, safe and effective use of new medicines by millions of American patients" (Newark Star-Ledger, 1/12). However, Sen. Chuck Grassley (R-Iowa) said that the proposed increase in user fees would provide only a "modest contribution" toward improved oversight of prescription drug safety. He said, "I don't want to denigrate any step in that direction when a step is made with good intention, but, to make sure the FDA is doing everything it should to keep American consumers safe, comprehensive reform of the agency's structure and culture is needed" (Miami Herald, 1/11). Bill Vaughan, senior policy analyst for Consumers Union, said, "At a time when countless drugs have safety problems, it isn't enough to just rely on money paid by the pharmaceutical industry to fund needed drug safety reforms" (CQ HealthBeat, 1/11).

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