IIB 

115TH CONGRESS 

2D SESSION H. R. 5473 

IN THE SENATE OF THE UNITED STATES 

JUNE 13, 2018 

Received; read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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HR 5473 RFS 

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Better Pain Manage3 ment Through Better Data Act of 2018’’. 

4 SEC. 2. GUIDANCE ADDRESSING ALTERNATIVE AP5 PROACHES TO DATA COLLECTION AND LA6 BELING CLAIMS FOR OPIOID SPARING. 

7 (a) IN GENERAL.—For purposes of assisting spon8 sors in collecting and incorporating opioid-sparing data in 

9 product labeling, the Secretary of Health and Human 

10 Services (referred to in this section as the ‘‘Secretary’’) 

11 shall conduct a public meeting and update or issue one 

12 or more guidances in accordance with subsection (b). 

13 (b) GUIDANCE.— 

14 (1) IN GENERAL.—The Secretary of Health and 

15 Human Services, acting through the Commissioner 

16 of Food and Drugs, shall update or issue one or 

17 more guidances addressing— 

18 (A) alternative methods for data collection 

19 on opioid sparing; 

20 (B) alternative methods for inclusion of 

21 such data in product labeling; and 

22 (C) investigations other than clinical trials, 

23 including partially controlled studies and objec24 tive trials without matched controls such as his25 torically controlled analyses, open-label studies, 


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1 and meta-analyses, on opioid sparing for inclu2 sion in product labeling. 

3 (2) CONTENTS.—The guidances under para4 graph (1) shall address— 

5 (A) innovative clinical trial designs for 

6 ethically and efficiently collecting data on opioid 

7 sparing for inclusion in product labeling; 

8 (B) primary and secondary endpoints for 

9 the reduction of opioid use while maintaining 

10 adequate pain control; 

11 (C) use of real world evidence, including 

12 patient registries, and patient reported out13 comes to support inclusion of opioid-sparing 

14 data in product labeling; and 

15 (D) how sponsors may obtain feedback 

16 from the Secretary relating to such issues prior 

17 to— 

18 (i) commencement of such data collec19 tion; or 

20 (ii) the submission of resulting data to 

21 the Secretary. 

22 (3) PUBLIC MEETING.—Prior to updating or 

23 issuing the guidances required by paragraph (1), the 

24 Secretary shall consult with stakeholders, including 

25 representatives of regulated industry, academia, paVerDate Sep 11 2014 00:10 Jun 14, 2018 Jkt 079200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5473.RFS H5473

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1 tients, and provider organizations, through a public 

2 meeting to be held not later than 12 months after 

3 the date of enactment of this Act. 

4 (4) TIMING.—The Secretary shall— 

5 (A) not later than 12 months after the 

6 date of the public meeting required by para7 graph (3), update or issue the one or more 

8 draft guidances required by paragraph (1); and 

9 (B) not later than 12 months after the 

10 date on which the public comment period for 

11 such draft guidances closes, finalize such guid12 ances. 

13 (c) DEFINITION.—In this section: 

14 (1) The terms ‘‘opioid sparing’’ and ‘‘opioid15 sparing’’ refer to the use of drugs or devices (as de16 fined in section 201 of the Federal Food, Drug, and 

17 Cosmetic Act (21 U.S.C. 321)) that reduce pain 

18 while enabling the reduction, replacement, or avoid19 ance of oral opioids. 


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1 (2) The term ‘‘Secretary’’ means the Secretary 

2 of Health and Human Services. 

Passed the House of Representatives June 12, 2018. 

Attest: KAREN L. HAAS, 

Clerk. 


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