{
  "id": "RL31453",
  "type": "CRS Report",
  "typeId": "REPORTS",
  "number": "RL31453",
  "active": false,
  "source": "EveryCRSReport.com",
  "versions": [
    {
      "source": "EveryCRSReport.com",
      "id": 101281,
      "date": "2002-10-07",
      "retrieved": "2016-05-24T20:03:54.111941",
      "title": "The Prescription Drug User Fee Act: Structure and Reauthorization Issues",
      "summary": "In 1992, Congress passed The Prescription Drug User Fee Act (PDUFA) to speed up the\napproval\nof pharmaceuticals in the United States. The legislation created sections 735 and 736 of the Federal\nFood, Drug and Cosmetic Act (FFDCA), authorizing the Food and Drug Administration (FDA) to\ncollect user fees from drug manufacturers in exchange for the faster review of drug and biological\nproducts. The law stipulated that the additional user fee revenues could only be used for activities \nnecessary to the review of human drug applications. It also specified that the revenues raised under\nthe program had to be \"in addition to\" baseline monies already dedicated to drug approvals. As\nCongress decides the agency's annual appropriation each year, it sets out the total amount of user\nfees that can be assessed during the upcoming fiscal year. To go with the user fee authority, but\nseparate from the law, the FDA, drug and biotech industries settled on specific annual performance\ngoals that were laid out in letters of agreement between the agency and Congress. To meet these\ngoals, FDA hired nearly 600 new reviewers, and upgraded its information system for tracking\npending drug applications. Congress authorized the first user fee program, referred to as PDUFA\nI, to run for a period of 5 years.\n  The original user fee law was reauthorized by Congress as part of the 1997 Food and Drug\nAdministration Modernization Act (FDAMA). Under the reauthorized statute, known as PDUFA\nII, agency and industry representatives agreed to a new set of annual performance goals to encourage\nthe timely processing of marketing applications. The FDA continued to hire more drug reviewers\nunder PDUFA II, so that today, more than 1,000 employees' salaries are supported by user fee\nrevenues. The funding for PDUFA II would have expired on September 30, 2002.\n  The FDA and the pharmaceutical industry generally agree that the user fee program has, to a\nlarge extent, been fairly successful. However, the program does have its critics who argue that the\nquicker review process could be compromising drug safety. To them, the number of prescription\ndrugs withdrawn in recent years is evidence that speedier approvals may be jeopardizing the health\nof some patients.\n  The 107th Congress reauthorized drug user fees in June 2002 as part of the bioterrorism bill\n( P.L. 107-188 ). Known as PDUFA III, the legislation extended the law for 5 more years, authorized\nvarious post-marketing activities to ensure the monitoring of drug safety, and allowed the agency\nto use user fees to review adverse event reports for drugs approved after October 1, 2002. The new\nlaw requires FDA to announce on its Internet site when drug manufacturers fail to complete 'Phase\nIV' post-market studies. In these situations, the agency may require companies to notify health\npractitioners who prescribe the drug of that failure and of the questions of clinical benefit, and, where\nappropriate, the questions of safety that remain unanswered as a result. In addition, the Act\nauthorized funding increases for three FDA offices: the office of drug safety; the division of drug\nmarketing, advertising and communications; and the office of generic drugs. This report will be\nupdated as events warrant.",
      "type": "CRS Report",
      "typeId": "REPORTS",
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      "topics": []
    }
  ],
  "topics": [
    "Domestic Social Policy"
  ]
}