{
  "id": "R40458",
  "type": "CRS Report",
  "typeId": "REPORTS",
  "number": "R40458",
  "active": false,
  "source": "EveryCRSReport.com",
  "versions": [
    {
      "source": "EveryCRSReport.com",
      "id": 417073,
      "date": "2009-03-19",
      "retrieved": "2016-04-07T02:38:52.491965",
      "title": "FDA Guidance Regarding the Promotion of Off-Label Uses of Drugs: Legal Issues",
      "summary": "New drugs may not be introduced or marketed without the approval of the Food and Drug Administration (FDA). When a person submits a drug application to the FDA for approval, the application includes samples of the proposed labeling. The FDA may refuse to approve an application if the drug is not safe or effective for the specific uses that are reflected in its labeling. An unapproved new use of a drug, also known as an off-label use, is a use not mentioned in the drug\u2019s approved labeling. Although a physician may prescribe a drug for off-label uses, a pharmaceutical manufacturer may not market or promote uses of a drug other than those on the label\u2014those uses approved by the FDA in the application.\nIn January 2009, the FDA issued a guidance document on the dissemination of medical information regarding off-label uses of drugs. The guidance seemingly creates a safe harbor for dissemination of information on off-label uses of FDA-approved drugs and medical devices. However, the agency\u2019s guidance statement does not have the force or effect of law, and the FDA still retains its legal authority under the Federal Food, Drug, and Cosmetic Act (FFDCA) and FDA regulations to determine when promotion of an unapproved new use has occurred or when a product is misbranded. Additionally, the guidance does not affect the legal authority, enforcement powers, or other capabilities of outside entities that have been involved in prosecuting False Claims Act (FCA) cases related to off-label marketing and the submission of false claims for reimbursement from the U.S. government.\nFirst, this report outlines the relevant provisions of the FFDCA and related regulations that have been used to address misbranding violations of the act that relate to pharmaceutical manufacturers\u2019 promotion of off-label use. Second, the report summarizes the FDA\u2019s previous off-label marketing provisions under the FDA Modernization Act of 1997 (FDAMA), which are no longer in effect. Third, the report details the January 2009 guidance document and its similarities to and differences from the FDAMA provisions. Fourth, the report outlines First Amendment challenges to FDAMA and older FDA guidance documents addressing off-label promotion. Fifth, the report discusses the nature of guidance documents, in contrast to rules promulgated under the Administrative Procedure Act (APA), as well as administrative law issues associated with the FDA\u2019s issuance of the guidance. Sixth, the report provides an overview of the FCA and related qui tam cases that addressed off-label marketing practices of pharmaceutical companies. Finally, the report analyzes the interaction of the new guidance document and the FCA.",
      "type": "CRS Report",
      "typeId": "REPORTS",
      "active": false,
      "formats": [
        {
          "format": "HTML",
          "encoding": "utf-8",
          "url": "http://www.crs.gov/Reports/R40458",
          "sha1": "96677436d834a6207f7016d0f0a62c0a80d1c283",
          "filename": "files/20090319_R40458_96677436d834a6207f7016d0f0a62c0a80d1c283.html",
          "images": null
        },
        {
          "format": "PDF",
          "encoding": null,
          "url": "http://www.crs.gov/Reports/pdf/R40458",
          "sha1": "4994d5a6a007fccae0b8eb6967a7d8cd2a39b795",
          "filename": "files/20090319_R40458_4994d5a6a007fccae0b8eb6967a7d8cd2a39b795.pdf",
          "images": null
        }
      ],
      "topics": []
    }
  ],
  "topics": []
}