[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 2089 Introduced in Senate (IS)]

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116th CONGRESS
  1st Session
                                S. 2089

 To prohibit the labeling of certain opioid drugs recommending use for 
                        long-term chronic pain.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 11, 2019

Mr. Manchin (for himself and Mr. Braun) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To prohibit the labeling of certain opioid drugs recommending use for 
                        long-term chronic pain.

    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 ``FDA Opioid Labeling Accuracy Act''.

SEC. 2. LABELING PROHIBITION.

    (a) In General.--Notwithstanding any other provision of law, the 
Secretary of Health and Human Services (referred to in this Act as the 
``Secretary'') may not approve labeling for an extended release or 
long-acting opioid analgesic drug unless, as applicable--
            (1) the labeling provides that such drug is not intended 
        for the treatment of chronic pain, except in the case of--
                    (A) treatment of pain related to cancer;
                    (B) end-of-life care; or
                    (C) a prescriber determination that, with respect 
                to a particular patient, other non-opioid pain 
                management treatments are inadequate or inappropriate; 
                or
            (2) the labeling is consistent with the regulations 
        promulgated by the Secretary pursuant to subsection (b).
    (b) Study and Labeling Regulations.--
            (1) In general.--Not later than 1 year after the date of 
        enactment of this Act, the Secretary shall--
                    (A) conduct a study on the efficacy of opioid 
                analgesic drugs for long-term chronic pain management; 
                and
                    (B) based on such study, promulgate regulations 
                regarding the labeling for extended release or long-
                acting opioid analgesic drugs, as scientifically 
                appropriate.
            (2) Updates.--The Secretary may update the regulations 
        promulgated under paragraph (1)(B), as appropriate.
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