{
  "id": "RS20971",
  "type": "CRS Report",
  "typeId": "REPORTS",
  "number": "RS20971",
  "active": false,
  "source": "EveryCRSReport.com",
  "versions": [
    {
      "source": "EveryCRSReport.com",
      "id": 100790,
      "date": "2001-07-25",
      "retrieved": "2016-05-24T20:22:19.026941",
      "title": "Orphan Drug Act: Background and Proposed Legislation in the 107th Congress",
      "summary": "The Orphan Drug Act ( P.L. 97-414 ) was signed into law on January 4, 1983. The Act provides\nincentives for pharmaceutical manufacturers to develop drugs, biotechnology products, and medical\ndevices for the treatment of rare diseases and conditions. These products are commonly referred to\nas orphan products. Incentives for orphan product development include marketing exclusivity for\norphan drug sponsors, tax incentives, and research grants. Since the Act was passed in 1983, the\nFood and Drug Administration (FDA) has approved 183 new orphan products. Critics of the Act\nargue that, because the Act relies on market-oriented strategies to promote orphan drug development,\noverpricing of drugs can limit patient access to orphan drug treatment, especially among those who\nlack health insurance. Others argue that the Act has been very successful in finding new treatments\nfor rare diseases and conditions, and that any changes to the incentives provided in the law would\nsuppress research and development. Legislation has been introduced in the 107th Congress to\nmodify\nmarketing exclusivity provisions, and to accelerate and expand tax benefits for orphan drug\nmanufacturers.",
      "type": "CRS Report",
      "typeId": "REPORTS",
      "active": false,
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      "topics": []
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  "topics": []
}