{
  "id": "R42540",
  "type": "CRS Report",
  "typeId": "REPORTS",
  "number": "R42540",
  "active": false,
  "source": "EveryCRSReport.com",
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      "source": "EveryCRSReport.com",
      "id": 408635,
      "date": "2012-05-18",
      "retrieved": "2016-04-07T00:06:56.095214",
      "title": "Proposed FDA User Fee Acts: Generic Drug User Fee Amendments of 2012 (GDUFA) and Biosimilar User Fee Act of 2012 (BSUFA)",
      "summary": "Congress is considering two new user fee authorities to supplement funding appropriated by Congress to FDA: the Generic Drug User Fee Amendments of 2012 (GDUFA), for activities related to human generic drug review, and the Biosimilar User Fee Act of 2012 (BSUFA), for biosimilar biological product review. A generic drug is identical to a brand-name (innovator) drug in dosage form and strength, route of administration, safety, effectiveness, and intended use. A biosimilar is a biological product that is highly similar to an innovator biological product. A biological product, or biologic, is a preparation, such as a drug or a vaccine, that is made from living organisms. In contrast to the relatively simple structure and manufacture of chemical drugs, biosimilars, with their more complex nature and method of manufacture, will not be identical to the brand-name product, but may instead be shown to be highly similar.\nS. 3187 and H.R. 5651 include GDUFA and BSUFA titles in legislative packages that also include the reauthorization of prescription drug (PDUFA) and medical device (MDUFA) user fee authorities, as well as other medical-product provisions. Because current PDUFA and MDUFA authorities sunset on October 1, 2012, leadership of both the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce have aimed for passage of the legislation enough before then to avoid disruption of FDA drug and device application review and postmarket safety activities. The proposed five-year authorities for GDUFA and BSUFA build on the model that has evolved since 1992 with the original PDUFA. User fees make up 36% of the overall FY2012 FDA budget, with percentages varying across the agency\u2019s programs.\nEach new user fee proposal consists of two parts: legislative language and an FDA-negotiated agreement with relevant industry groups. The GDUFA bill language specifies the types of fees, amount of revenue authorized to be collected, and a broad definition of activities on which FDA may use that revenue. It refers to a required FDA-industry agreement that lays out performance goals and procedures. The legislative language would authorize FDA to collect $299 million in generic drug user fees per year. For the first year of this authority, $50 million of total collections would come from fees for currently pending applications. To ensure that generic drug user fee revenue supplements, rather than replaces, congressionally appropriated funds, the bill would require that (1) each year\u2019s appropriations bill include at least the same level of non-user fee appropriations, adjusted for inflation, as in FY2009 for overall FDA salaries and expenses, and (2) the Secretary allocate at least $97 million, excluding fees and adjusted for inflation, each year for specified human generic drug activities. FDA commitments outlined in the agreement include specified timetables for the review of, and action on, the various types of submissions; risk-based inspections of foreign and domestic generic drug facilities; and regulatory science initiatives.\nThe BSUFA proposal would require the collection of six types of fees from the regulated industry, which is composed primarily of biotechnology and pharmaceutical companies. Fee amounts would be based on inflation-adjusted PDUFA fee amounts for each fiscal year. Because there are no currently marketed biosimilar biological products, the proposal includes fees for products in the development phase to generate fee revenue for the new program and to enable companies to have meetings with FDA in the early development of biosimilar biological products. Both the legislative language and the performance goals document state that the agency goals are contingent on, in addition to user fees, the allocation for each fiscal year of at least $20 million (inflation adjusted value) in non-user fee funds to support the review of biosimilar biological product applications.",
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      "typeId": "REPORTS",
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      "topics": []
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  "topics": [
    "Appropriations"
  ]
}