I 

115TH CONGRESS 

2D SESSION H. R. 5473 

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. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 11, 2018 

Mrs. COMSTOCK (for herself and Mr. BEN RAY LUJA ́N of New Mexico) introduced the following bill; which was referred to the Committee on Energy 

and Commerce 

A BILL 

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, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Better Pain Manage5 ment Through Better Data Act of 2018’’. 


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1 SEC. 2. GUIDANCE ADDRESSING ALTERNATIVE AP2 PROACHES TO DATA COLLECTION AND LA3 BELING CLAIMS FOR OPIOID SPARING. 

4 (a) IN GENERAL.—For purposes of assisting spon5 sors in collecting and incorporating opioid-sparing data in 

6 product labeling, the Secretary of Health and Human 

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

8 shall conduct a public meeting and update or issue one 

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

10 (b) GUIDANCE.— 

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

12 Human Services, acting through the Commissioner 

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

14 more guidances addressing— 

15 (A) alternative methods for data collection 

16 on opioid sparing; 

17 (B) alternative methods for inclusion of 

18 such data in product labeling; and 

19 (C) investigations other than clinical trials, 

20 including partially controlled studies and objec21 tive trials without matched controls such as his22 torically controlled analyses, open-label studies, 

23 and meta-analyses, on opioid sparing for inclu24 sion in product labeling. 

25 (2) CONTENTS.—The guidances under para26 graph (1) shall address— 


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1 (A) innovative clinical trial designs for 

2 ethically and efficiently collecting data on opioid 

3 sparing for inclusion in product labeling; 

4 (B) primary and secondary endpoints for 

5 the reduction of opioid use while maintaining 

6 adequate pain control; 

7 (C) use of real world evidence, including 

8 patient registries, and patient reported out9 comes to support inclusion of opioid-sparing 

10 data in product labeling; and 

11 (D) how sponsors may obtain feedback 

12 from the Secretary relating to such issues prior 

13 to— 

14 (i) commencement of such data collec15 tion; or 

16 (ii) the submission of resulting data to 

17 the Secretary. 

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

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

20 Secretary shall consult with stakeholders, including 

21 representatives of regulated industry, academia, pa22 tients, and provider organizations, through a public 

23 meeting to be held not later than 12 months after 

24 the date of enactment of this Act. 

25 (4) TIMING.—The Secretary shall— 


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1 (A) not later than 12 months after the 

2 date of the public meeting required by para3 graph (3), update or issue the one or more 

4 draft guidances required by paragraph (1); and 

5 (B) not later than 12 months after the 

6 date on which the public comment period for 

7 such draft guidances closes, finalize such guid8 ances. 

9 (c) DEFINITION.—In this section: 

10 (1) The terms ‘‘opioid sparing’’ and ‘‘opioid11 sparing’’ refer to the use of drugs or devices (as de12 fined in section 201 of the Federal Food, Drug, and 

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

14 while enabling the reduction, replacement, or avoid15 ance of oral opioids. 

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

17 of Health and Human Services. 

Æ 


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