S. 2608 – Reducing Opioid Risk Act

AI-Generated Summary

Updated April 15, 2026 at 9:02 PM UTC

The Reducing Opioid Risk Act changes federal law so that a drug’s Risk Evaluation and Mitigation Strategy (REMS) communication plan can include information about federal and state prescribing rules for controlled substances. By allowing this additional information, the bill aims to help health‑care providers follow prescribing requirements that can lower opioid misuse. The change mainly affects drug manufacturers that must create REMS plans and the providers who receive those communications.

Key Provisions

Amends the Federal Food, Drug, and Cosmetic Act to add a new subparagraph (E) to the list of permissible REMS communication activities.
The new subparagraph authorizes the dissemination of information to health‑care providers about federal and state prescribing requirements for controlled substances, including requirements under the Controlled Substances Act.

Legislative Activity

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1 earlier action

SenateIntro Referral Latest Action

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

Health, Education, Labor, and Pensions Committee

March 22, 2018

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SenateIntro Referral

Introduced in Senate

March 22, 2018

SenateIntro Referral

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

Health, Education, Labor, and Pensions Committee

March 22, 2018

Bill Text

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Introduced in SenateIssued March 22, 2018

II

115th CONGRESS

2d Session

S. 2608

IN THE SENATE OF THE UNITED STATES

March 22, 2018

Ms. Warren (for herself and Mrs. Capito) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To provide that a risk evaluation and mitigation strategy communication plan may include information about Federal and State prescribing requirements for controlled substances.

1.

Short title

This Act may be cited as the Reducing Opioid Risk Act.

2.

Risk evaluation and mitigation strategy communication plans

Section 505–1(e)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(e)(3)) is amended—

(1)

in subparagraph (B), by adding a semicolon at the end;

(2)

in subparagraph (C), by striking ; or and inserting a semicolon;

(3)

in subparagraph (D), by striking the period and inserting ; or; and

(4)

by adding at the end the following:

(E)

disseminating information to health care providers about Federal and State prescribing requirements for controlled substances, including the requirements under section 309(f) of the Controlled Substances Act, as applicable.

.