What This Bill Does
This bill requires the Food and Drug Administration to revoke approval of one existing opioid pain medication each time it approves a new opioid pain medication. The bill's official name is the "Protecting Americans from Dangerous Opioids Act."
Who It Affects
The Secretary of Health and Human Services (the federal official who oversees the Food and Drug Administration) is directly responsible for carrying out this requirement.
Key Provisions
• Whenever the Secretary approves a new opioid drug application, the Secretary must revoke approval of another opioid drug that was previously approved (Sec. 3(a))
• When choosing which opioid drug to revoke approval for, the Secretary must prioritize removing opioid drugs that do not have abuse deterrent formulations (meaning drugs without features designed to prevent misuse) (Sec. 3(b)(1))
• When choosing which opioid drug to revoke approval for, the Secretary must consider the public health impact of keeping that opioid drug on the market (Sec. 3(b)(2))
What Changes
If this bill becomes law, the Food and Drug Administration must remove one currently approved opioid pain medication from the market each time it approves a new opioid pain medication.
Important Definitions
None defined in bill text.
II
118TH CONGRESS
1ST SESSION
S. 606
To require the Food and Drug Administration to revoke the approval of
one opioid pain medication for each new opioid pain medication approved.
IN THE SENATE OF THE UNITED STATES
MARCH 1, 2023
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 require the Food and Drug Administration to revoke
the approval of one opioid pain medication for each new
opioid pain medication approved.
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 ‘‘Protecting Americans
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from Dangerous Opioids Act’’.
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SEC. 2. FINDINGS.
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Congress finds as follows:
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(1) Drug overdoses killed more than 107,000
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people in the United States in 2021. Nearly two-
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•S 606 IS
thirds of all drug overdose deaths involved a pre-
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scription opioid or synthetic opioid.
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(2) According to the National Institute on Drug
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Abuse, 80 percent of new heroin users abused pre-
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scription opioids before moving to heroin.
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(3) The United States makes up only 4.25 per-
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cent of the world’s population, but consumes 80 per-
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cent of its opioid pain medications.
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(4) In 2020, health care providers in the United
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States wrote nearly 143,000,000 prescriptions for
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painkillers, which is 43 prescriptions per 100 people.
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(5) The amount of prescription opioids sold in
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the United States has increased without a reported
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increase in pain. At the same time, overdose deaths
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involving opioids have quadrupled since 1999, with
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more than 932,000 people having died from a drug
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overdose.
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(6) Although overdose death rates are begin-
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ning to see a slow decline, over 106,000 people are
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predicted to have died of drug overdose in 2022.
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SEC. 3. REQUIREMENT TO REVOKE APPROVAL.
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(a) IN GENERAL.—Notwithstanding any other provi-
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sion of law, if the Secretary of Health and Human Serv-
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ices (referred to in this section as the ‘‘Secretary’’) ap-
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proves an application under subsection (b) or (j) of section
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•S 606 IS
505 of the Federal Food, Drug, and Cosmetic Act (21
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U.S.C. 355) for an opioid drug, the Secretary shall revoke
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the approval of another opioid drug previously approved
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under subsection (c) or (j) of such section 505.
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(b) CONSIDERATIONS.—In determining the drug for
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which the Secretary will revoke approval pursuant to sub-
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section (a), the Secretary shall—
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(1) prioritize revocation of non-abuse deterrent
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formulations of opioid drugs; and
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(2) consider the public health impact of the
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opioid drug being on the market.
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Æ
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