[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 1049 Introduced in Senate (IS)]

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115th CONGRESS
  1st Session
                                S. 1049

  To allow the Secretary of Health and Human Services to require that 
  risk evaluation and mitigation strategies for certain drugs include 
communication plans that provide information about drug formulations or 
               properties described in the drug labeling.


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                   IN THE SENATE OF THE UNITED STATES

                              May 4, 2017

 Ms. Hassan (for herself and Mr. Young) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

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                                 A BILL


 
  To allow the Secretary of Health and Human Services to require that 
  risk evaluation and mitigation strategies for certain drugs include 
communication plans that provide information about drug formulations or 
               properties described in the drug labeling.

    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 ``Opioid Addiction Risk Transparency 
Act''.

SEC. 2. REMS COMMUNICATION PLANS.

    Section 505-1(e)(3) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355-1(e)(3)) is amended--
            (1) in subparagraph (B), by striking ``; or'';
            (2) in subparagraph (C), by striking the period and 
        inserting ``; or''; and
            (3) by adding at the end the following:
                    ``(D) disseminating information to health care 
                providers about the meaning of terms related to drug 
                formulations or properties that are described in the 
                drug labeling, including information about the 
                limitations or patient care implications of such 
                formulations or properties, and how such formulations 
                or properties may be related to serious adverse drug 
                events associated with use of the drug.''.
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