[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6133 Introduced in House (IH)]

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115th CONGRESS
  2d Session
                                H. R. 6133

  To deter opioid abuse and addiction through the development of high-
 quality, evidence-based opioid analgesic prescribing guidelines, and 
                          for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 19, 2018

 Mr. Meadows introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
  To deter opioid abuse and addiction through the development of high-
 quality, evidence-based opioid analgesic prescribing guidelines, and 
                          for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Informing Opioid Prescribing Through 
Evidence-Based Guidelines Act of 2018''.

SEC. 2. STUDY AND REPORT.

    (a) Study.--The Commissioner of Food and Drugs shall develop high-
quality, evidence-based opioid analgesic prescribing guidelines for the 
indication-specific treatment of acute pain in the relevant therapeutic 
areas where such high-quality, evidence-based opioid analgesic 
prescribing guidelines--
            (1) do not exist; and
            (2) are not redundant of existing guidelines.
    (b) Public Input.--In conducting the study under subsection (a), 
the Commissioner of Food and Drugs shall--
            (1) conduct a public workshop, open to representatives of 
        State medical societies and medical boards, various medical 
        specialties including pain medicine specialty societies, 
        patient groups, universities, and others; and
            (2) provide a period for the submission of comments by the 
        public.
    (c) Report.--Not later than the date that is 2 years after the date 
of enactment of this Act, the Commissioner of Food and Drugs shall 
submit to the Congress, and post on the public website of the Food and 
Drug Administration, a report on the results of the study under 
subsection (a).
    (d) Updates.--On a biennial basis after submission of the report 
required by subsection (c), the Commissioner of Food and Drugs shall--
            (1) update the study under subsection (a), informed by 
        public input described in subsection (b); and
            (2) submit to the Congress and post on the public website 
        of the Food and Drug Administration an updated report under 
        subsection (c).

SEC. 3. EVIDENCE-BASED REGULATIONS, GUIDANCE, AND POLICIES TO INFORM 
              CLINICAL OPIOID PRACTICES.

    (a) In General.--To the maximum extent possible, the Commissioner 
of Food and Drugs shall ensure that regulations, guidance, and polices 
that are related to opioid prescribing practices and issued after the 
date of enactment of this Act are based on opioid prescribing practices 
that are evidence-based.
    (b) Statement To Accompany Guidelines and Recommendations.--The 
Commissioner of Food and Drugs shall ensure that any opioid analgesic 
prescribing guidelines and other recommendations developed under this 
Act are accompanied by a clear statement that such guidelines or 
recommendations, as applicable--
            (1) are intended to help inform clinical decisionmaking by 
        prescribers and patients; and
            (2) should not be used by other parties, including pharmacy 
        benefit management companies, retail or community pharmacies, 
        or public and private payors, for the purposes of restricting, 
        limiting, delaying, or denying coverage for or access to a 
        prescription issued for a legitimate medical purpose by an 
        individual practitioner acting in the usual course of 
        professional practice.
    (c) Definition.--In this section, the term ``evidence-based'' means 
informed by a robust and systemic review of treatment efficacy and 
clinical evidence, including a review of the study and reports under 
section 2.
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