II 

115TH CONGRESS 

2D SESSION S. 2665 

To require guidance on how the Food and Drug Administration will consider 

claims of opioid sparing and on the conditions under which the Food 

and Drug Administration will consider misuse and abuse of drugs in 

making certain determinations of safety. 

IN THE SENATE OF THE UNITED STATES 

APRIL 12, 2018 

Mr. YOUNG (for himself and Mr. DONNELLY) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the 

conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making 

certain determinations of safety. 

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

3 SECTION 1. OPIOID SPARING CLAIMS AND INDICATIONS. 

4 (a) OPIOID SPARING.— 

5 (1) DRAFT GUIDANCE.—Not later than 1 year 

6 after the date of enactment of this Act, the Sec7 retary, acting through the Commissioner of Food 


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1 and Drugs, shall issue draft guidance to clarify how 

2 the Food and Drug Administration will assess evi3 dence to support claims of opioid sparing for non4 opioid or other non-addictive medical products in5 tended to treat pain. Such guidance shall include— 

6 (A) data collection methodologies, includ7 ing the use of innovative clinical trial designs 

8 (consistent with section 3021 of the 21st Cen9 tury Cures Act (Public Law 114–255)), and 

10 real world evidence (as defined in section 

11 505F(b) of the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 355g(b))), as appropriate, 

13 to support product labeling; 

14 (B) ethical implications of exposure to con15 trolled substances in clinical trials to support 

16 opioid sparing claims and considerations on 

17 methods to reduce harm; 

18 (C) endpoints, including primary, sec19 ondary, and surrogate endpoints, to evaluate 

20 the reduction in opioid use; 

21 (D) best practices for communication be22 tween sponsors and the agency on the develop23 ment of such data collection methods, including 

24 the initiation of data collection; and 


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1 (E) the appropriate format to submit such 

2 data results to the Secretary. 

3 (2) FINAL GUIDANCE.—Not later than 6 

4 months after the close of the period for public com5 ment on the draft guidance under paragraph (1), 

6 the Secretary shall finalize such guidance. 

7 (b) RISK OF ABUSE AND MISUSE.— 

8 (1) DRAFT GUIDANCE.—Not later than 1 year 

9 after the date of enactment of this Act, the Sec10 retary, acting through the Commissioner of Food 

11 and Drugs, shall issue draft guidance to clarify the 

12 circumstances under which the Food and Drug Ad13 ministration considers misuse and abuse of drugs in 

14 making determinations of safety under paragraphs 

15 (2) and (4) of subsection (d) of section 505 of the 

16 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

17 355) and in finding that a drug is unsafe under 

18 paragraph (1) or (2) of subsection (e) of such sec19 tion. 

20 (2) FINAL GUIDANCE.—Not later than 6 

21 months after the close of the period for public com22 ment on the draft guidance under paragraph (1), 

23 the Secretary shall finalize such guidance. 

24 (c) DEFINITIONS.—In this section— 


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1 (1) the term ‘‘medical product’’ means a drug 

2 (as that term is defined by section 201(g)(1) of the 

3 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

4 321(g)(1))), biological product (as that term is de5 fined by section 351(i) of this Act (42 U.S.C. 

6 262(i))), or device (as that term is defined by sec7 tion 201(h) of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 321(h))); and 

9 (2) the term ‘‘opioid sparing’’ means reducing 

10 the use of opioids or other controlled substances. 

Æ 


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