{
  "id": "RL33914",
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      "id": 403440,
      "date": "2008-06-27",
      "retrieved": "2016-04-07T03:20:06.742365",
      "title": "The Prescription Drug User Fee Act: History Through the 2007 PDUFA IV Reauthorization",
      "summary": "This report, last updated in June 2008, provides a history of the Prescription Drug User Fee Act through its third reauthorization\u2014as PDUFA IV\u2014in September 2007. As the 112th Congress turns to the law\u2019s next reauthorization\u2014PDUFA V, CRS has prepared another report that describes current law and the PDUFA V proposal (legislative language and the performance goals Agreement between FDA and industry representatives). It also explores the impact of PDUFA on FDA application review time and the agency\u2019s Human Drugs Program budget, and issues that Congress is likely to discuss as it prepares for anticipated PDUFA V reauthorization. For activity in the 112th Congress, please see CRS Report R42366, Prescription Drug User Fee Act (PDUFA): Issues for Reauthorization (PDUFA V) in 2012, by Susan Thaul.\nIn 1992, Congress passed the Prescription Drug User Fee Act (PDUFA I) to give the Food and Drug Administration (FDA) a revenue source\u2014fees paid by the pharmaceutical manufacturers\u2014to supplement, not replace, direct appropriations. The impetus behind the 1992 law stemmed from the length of time between a manufacturer\u2019s submission of an FDA New Drug Application (NDA) or Biologics License Application (BLA) and the agency\u2019s decision on approval or licensure. FDA had attributed the delay, which affected patients and manufacturers, to constraints on its ability to hire and support review staff. Congress reauthorized the user fee program in 1997 (PDUFA II), in 2002 (PDUFA III), and, most recently, in 2007 (PDUFA IV), as Title I of the Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85).\nCongress intended PDUFA to diminish the backlog of applications at FDA and increasingly shorten the time from submission to decision. PDUFA II expanded the program\u2019s scope to include activities related to the investigational phases of a new drug\u2019s development, and to increase FDA communications with industry and consumer groups. PDUFA III again expanded the scope of authorized activities to include both preclinical development and a three-year postapproval period.\nIn keeping with the law, FDA has worked with the drug manufacturers to set PDUFA performance goals, which the Secretary of Health and Human Services (HHS) has submitted in letters to the chairs of the relevant congressional authorizing committees. The Secretary also submits annual performance and financial reports.\nIn crafting PDUFA IV, the most recent reauthorization, the 110th Congress addressed workload and compensation adjustments; expanded the authorized range of safety activities to include development of data collection systems and analytic tools, and enforcement of postapproval study, labeling, and risk evaluation and mitigation strategy requirements; increased public communication requirements; and authorized a user fee for the advisory review of prescription drug television ads.\nThe general view is that PDUFA has succeeded. FDA has added review staff and reduced its review times. At each reauthorization, however, discussion returns to certain issues in the context of PDUFA that also reflect broader FDA concerns. These include budget choices under limited resources, including the relationship between direct appropriations and user fees; the identification and amelioration of conflicts of interest when the regulated industry is a major source of industry funding; and the tension between making new drugs available to the public and ensuring that those drugs be safe and effective.",
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    {
      "source": "University of North Texas Libraries Government Documents Department",
      "sourceLink": "https://digital.library.unt.edu/ark:/67531/metadc810020/",
      "id": "RL33914_2007Mar13",
      "date": "2007-03-13",
      "retrieved": "2016-03-19T13:57:26",
      "title": "The Prescription Drug User Fee Act (PDUFA): Background and Issues for PDUFA IV Reauthorization",
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