Bill SponsorBILLSPONSOR
Bill Sponsor
Politicians
Bills
Senate Bill 2089
116th Congress(2019-2020)
FDA Opioid Labeling Accuracy Act
Introduced
Introduced
Introduced in Senate on Jul 11, 2019
Overview
Text
Introduced in Senate 
Jul 11, 2019
Not Scanned for Linkage
About Linkage
Multiple bills can contain the same text. This could be an identical bill in the opposite chamber or a smaller bill with a section embedded in a larger bill.
Bill Sponsor regularly scans bill texts to find sections that are contained in other bill texts. When a matching section is found, the bills containing that section can be viewed by clicking "View Bills" within the bill text section.
Bill Sponsor is currently only finding exact word-for-word section matches. In a future release, partial matches will be included.
Introduced in Senate(Jul 11, 2019)
Jul 11, 2019
Not Scanned for Linkage
About Linkage
Multiple bills can contain the same text. This could be an identical bill in the opposite chamber or a smaller bill with a section embedded in a larger bill.
Bill Sponsor regularly scans bill texts to find sections that are contained in other bill texts. When a matching section is found, the bills containing that section can be viewed by clicking "View Bills" within the bill text section.
Bill Sponsor is currently only finding exact word-for-word section matches. In a future release, partial matches will be included.
Jump To
S. 2089 (Introduced-in-Senate)


116th CONGRESS
1st Session
S. 2089


To prohibit the labeling of certain opioid drugs recommending use for long-term chronic pain.

IN THE SENATE OF THE UNITED STATES

July 11, 2019

Mr. Manchin (for himself and Mr. Braun) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To prohibit the labeling of certain opioid drugs recommending use for long-term chronic pain.

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

SECTION 1. Short title.

This Act may be cited as the “FDA Opioid Labeling Accuracy Act”.

SEC. 2. Labeling prohibition.

(a) In general.—Notwithstanding any other provision of law, the Secretary of Health and Human Services (referred to in this Act as the “Secretary”) may not approve labeling for an extended release or long-acting opioid analgesic drug unless, as applicable—

(1) the labeling provides that such drug is not intended for the treatment of chronic pain, except in the case of—

(A) treatment of pain related to cancer;

(B) end-of-life care; or

(C) a prescriber determination that, with respect to a particular patient, other non-opioid pain management treatments are inadequate or inappropriate; or

(2) the labeling is consistent with the regulations promulgated by the Secretary pursuant to subsection (b).

(b) Study and labeling regulations.—

(1) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, the Secretary shall—

(A) conduct a study on the efficacy of opioid analgesic drugs for long-term chronic pain management; and

(B) based on such study, promulgate regulations regarding the labeling for extended release or long-acting opioid analgesic drugs, as scientifically appropriate.

(2) UPDATES.—The Secretary may update the regulations promulgated under paragraph (1)(B), as appropriate.