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S. 2665Senate115th Congress (2017-2019)In Committee

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.

Sponsored by Todd YoungSen. Todd Young (R-IN)
Introduced April 12, 2018

AI-Generated Summary

Updated April 15, 2026 at 9:13 PM UTC

The bill directs the Food and Drug Administration to develop guidance on two topics: how it will evaluate claims that a medical product reduces opioid use (opioid‑sparing) and when it will consider drug misuse or abuse in safety assessments. The guidance must be drafted within a year of the law’s enactment and finalized after public comment, affecting manufacturers of drugs, biologics, and devices that seek FDA approval or labeling.

Key Provisions

  • The FDA must issue draft guidance within one year on how to assess evidence supporting opioid‑sparing claims for non‑opioid pain treatments, covering data collection methods, clinical trial designs, real‑world evidence, ethical issues, endpoints, sponsor‑agency communication, and submission formats.
  • A final version of the opioid‑sparing guidance must be issued within six months after the public comment period ends.
  • The FDA must also issue draft guidance within one year on the circumstances under which misuse and abuse of drugs are considered in safety determinations, with a final version issued six months after comment.
  • The bill defines “medical product” to include drugs, biologics, and devices, and defines “opioid sparing” as reducing the use of opioids or other controlled substances.

Legislative Activity

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SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

April 12, 2018

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SenateIntro Referral

Introduced in Senate

April 12, 2018

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

April 12, 2018

Bill Text

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Introduced in SenateIssued April 12, 2018

II

115th CONGRESS

2d Session

S. 2665

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.

Opioid sparing claims and indications

(a)

Opioid sparing

(1)

Draft guidance

Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall issue draft guidance to clarify how the Food and Drug Administration will assess evidence to support claims of opioid sparing for non-opioid or other non-addictive medical products intended to treat pain. Such guidance shall include—

(A)

data collection methodologies, including the use of innovative clinical trial designs (consistent with section 3021 of the 21st Century Cures Act (Public Law 114–255)), and real world evidence (as defined in section 505F(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g(b))), as appropriate, to support product labeling;

(B)

ethical implications of exposure to controlled substances in clinical trials to support opioid sparing claims and considerations on methods to reduce harm;

(C)

endpoints, including primary, secondary, and surrogate endpoints, to evaluate the reduction in opioid use;

(D)

best practices for communication between sponsors and the agency on the development of such data collection methods, including the initiation of data collection; and

(E)

the appropriate format to submit such data results to the Secretary.

(2)

Final guidance

Not later than 6 months after the close of the period for public comment on the draft guidance under paragraph (1), the Secretary shall finalize such guidance.

(b)

Risk of abuse and misuse

(1)

Draft guidance

Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall issue draft guidance to clarify the circumstances under which the Food and Drug Administration considers misuse and abuse of drugs in making determinations of safety under paragraphs (2) and (4) of subsection (d) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and in finding that a drug is unsafe under paragraph (1) or (2) of subsection (e) of such section.

(2)

Final guidance

Not later than 6 months after the close of the period for public comment on the draft guidance under paragraph (1), the Secretary shall finalize such guidance.

(c)

Definitions

In this section—

(1)

the term medical product means a drug (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as that term is defined by section 351(i) of this Act (42 U.S.C. 262(i))), or device (as that term is defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))); and

(2)

the term opioid sparing means reducing the use of opioids or other controlled substances.