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II
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, Edu-
cation, 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 Representa-
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tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE.
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This Act may be cited as the ‘‘FDA Opioid Labeling
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Accuracy Act’’.
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SEC. 2. LABELING PROHIBITION.
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(a) IN GENERAL.—Notwithstanding any other provi-
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sion of law, the Secretary of Health and Human Services
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(referred to in this Act as the ‘‘Secretary’’) may not ap-
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•S 2089 IS
prove labeling for an extended release or long-acting opioid
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analgesic drug unless, as applicable—
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(1) the labeling provides that such drug is not
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intended for the treatment of chronic pain, except in
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the case of—
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(A) treatment of pain related to cancer;
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(B) end-of-life care; or
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(C) a prescriber determination that, with
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respect to a particular patient, other non-opioid
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pain management treatments are inadequate or
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inappropriate; or
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(2) the labeling is consistent with the regula-
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tions promulgated by the Secretary pursuant to sub-
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section (b).
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(b) STUDY AND LABELING REGULATIONS.—
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(1) IN GENERAL.—Not later than 1 year after
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the date of enactment of this Act, the Secretary
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shall—
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(A) conduct a study on the efficacy of
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opioid analgesic drugs for long-term chronic
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pain management; and
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(B) based on such study, promulgate regu-
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lations regarding the labeling for extended re-
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lease or long-acting opioid analgesic drugs, as
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scientifically appropriate.
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•S 2089 IS
(2) UPDATES.—The Secretary may update the
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regulations promulgated under paragraph (1)(B), as
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appropriate.
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Æ
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