{
  "id": "R45405",
  "type": "CRS Report",
  "typeId": "REPORTS",
  "number": "R45405",
  "active": true,
  "source": "EveryCRSReport.com",
  "versions": [
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      "source": "EveryCRSReport.com",
      "id": 603197,
      "date": "2018-11-15",
      "retrieved": "2019-08-12T22:19:30.085217",
      "title": "The SUPPORT for Patients and Communities Act (P.L. 115-271): Food and Drug Administration and Controlled Substance Provisions",
      "summary": "On October 24, 2018, President Trump signed into law H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (P.L. 115-271; the SUPPORT for Patients and Communities Act, or the SUPPORT Act). \nThe SUPPORT Act is a sweeping measure designed to address widespread overprescribing and abuse of opioids in the United States. The act includes provisions involving law enforcement, public health, and health care financing and coverage. Broadly, the legislation imposes tighter oversight of opioid production and distribution; imposes additional reporting and safeguards to address fraud; and limits coverage of prescription opioids, while expanding coverage of and access to opioid addiction treatment services. The bill also authorizes a number of programs that seek to expand consumer education on opioid use and train additional providers to treat individuals with opioid use disorders.\nThe SUPPORT Act builds on recent efforts by the federal government to address the opioid epidemic, including the Comprehensive Addiction and Recovery Act of 2016 (CARA; P.L. 114-198) and the 21st Century Cures Act (Cures Act; P.L. 114-255). CARA addressed substance use issues broadly, targeting the opioid crisis predominantly through public health and law enforcement strategies. The Cures Act, enacted that same year, largely focused on medical innovation but also authorized additional funding to combat opioid addiction and included provisions addressing various mental health and substance use activities. \nCRS is publishing a series of reports on the SUPPORT Act, which consists of eight titles. This report summarizes the provisions in Title III\u2014the FDA (Food and Drug Administration) and Controlled Substance Provisions, as well as Section 4004 \u201cModernizing the Reporting Requirements of Biological and Biosimilar Products\u201d in Title IV\u2014Offsets. \nSubtitle A of Title III addresses FDA medical product regulation and includes provisions that, among other things,\nfacilitate the development of new medical products for treatment of pain,\nprovide for special packaging and disposal mechanisms for opioids, and\namend postmarket study and labeling requirements.\nSubtitle B of Title III addresses Drug Enforcement Administration (DEA) regulation of controlled substances and includes provisions that, among other things,\nprovide additional flexibility with respect to medication-assisted treatment (MAT) for opioid use disorders,\nmodify controlled substances disposal requirements at qualified hospice programs, and\nauthorize grants to states to increase participation of eligible collectors in drug-disposal programs.\nSection 4004 of Title IV amends reporting requirements for certain agreements between brand drug, generic drug, and biosimilar product manufacturers.",
      "type": "CRS Report",
      "typeId": "REPORTS",
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      "topics": [
        {
          "source": "IBCList",
          "id": 4793,
          "name": "Drug Control"
        },
        {
          "source": "IBCList",
          "id": 4880,
          "name": "FDA Product Regulation & Medical Research"
        }
      ]
    }
  ],
  "topics": [
    "Crime Policy",
    "Health Policy"
  ]
}