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[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5473 Engrossed in House (EH)]

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115th CONGRESS
  2d Session
                                H. R. 5473

_______________________________________________________________________

                                 AN ACT

 
To direct the Secretary of Health and Human Services to update or issue 
     one or more guidances addressing alternative methods for data 
  collection on opioid sparing and inclusion of such data in product 
                   labeling, 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 ``Better Pain Management Through 
Better Data Act of 2018''.

SEC. 2. GUIDANCE ADDRESSING ALTERNATIVE APPROACHES TO DATA COLLECTION 
              AND LABELING CLAIMS FOR OPIOID SPARING.

    (a) In General.--For purposes of assisting sponsors in collecting 
and incorporating opioid-sparing data in product labeling, the 
Secretary of Health and Human Services (referred to in this section as 
the ``Secretary'') shall conduct a public meeting and update or issue 
one or more guidances in accordance with subsection (b).
    (b) Guidance.--
            (1) In general.--The Secretary of Health and Human 
        Services, acting through the Commissioner of Food and Drugs, 
        shall update or issue one or more guidances addressing--
                    (A) alternative methods for data collection on 
                opioid sparing;
                    (B) alternative methods for inclusion of such data 
                in product labeling; and
                    (C) investigations other than clinical trials, 
                including partially controlled studies and objective 
                trials without matched controls such as historically 
                controlled analyses, open-label studies, and meta-
                analyses, on opioid sparing for inclusion in product 
                labeling.
            (2) Contents.--The guidances under paragraph (1) shall 
        address--
                    (A) innovative clinical trial designs for ethically 
                and efficiently collecting data on opioid sparing for 
                inclusion in product labeling;
                    (B) primary and secondary endpoints for the 
                reduction of opioid use while maintaining adequate pain 
                control;
                    (C) use of real world evidence, including patient 
                registries, and patient reported outcomes to support 
                inclusion of opioid-sparing data in product labeling; 
                and
                    (D) how sponsors may obtain feedback from the 
                Secretary relating to such issues prior to--
                            (i) commencement of such data collection; 
                        or
                            (ii) the submission of resulting data to 
                        the Secretary.
            (3) Public meeting.--Prior to updating or issuing the 
        guidances required by paragraph (1), the Secretary shall 
        consult with stakeholders, including representatives of 
        regulated industry, academia, patients, and provider 
        organizations, through a public meeting to be held not later 
        than 12 months after the date of enactment of this Act.
            (4) Timing.--The Secretary shall--
                    (A) not later than 12 months after the date of the 
                public meeting required by paragraph (3), update or 
                issue the one or more draft guidances required by 
                paragraph (1); and
                    (B) not later than 12 months after the date on 
                which the public comment period for such draft 
                guidances closes, finalize such guidances.
    (c) Definition.--In this section:
            (1) The terms ``opioid sparing'' and ``opioid-sparing'' 
        refer to the use of drugs or devices (as defined in section 201 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) 
        that reduce pain while enabling the reduction, replacement, or 
        avoidance of oral opioids.
            (2) The term ``Secretary'' means the Secretary of Health 
        and Human Services.

            Passed the House of Representatives June 12, 2018.

            Attest:

                                                                 Clerk.
115th CONGRESS

  2d Session

                               H. R. 5473

_______________________________________________________________________

                                 AN ACT

To direct the Secretary of Health and Human Services to update or issue 
     one or more guidances addressing alternative methods for data 
  collection on opioid sparing and inclusion of such data in product 
                   labeling, and for other purposes.
```