Protecting Americans from Dangerous Opioids Act

Subjects: Health


<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 606 Introduced in Senate (IS)]

&lt;DOC&gt;






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, 
                     Education, 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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Protecting Americans from Dangerous 
Opioids Act''.

SEC. 2. FINDINGS.

    Congress finds as follows:
            (1) Drug overdoses killed more than 107,000 people in the 
        United States in 2021. Nearly two-thirds of all drug overdose 
        deaths involved a prescription opioid or synthetic opioid.
            (2) According to the National Institute on Drug Abuse, 80 
        percent of new heroin users abused prescription opioids before 
        moving to heroin.
            (3) The United States makes up only 4.25 percent of the 
        world's population, but consumes 80 percent of its opioid pain 
        medications.
            (4) In 2020, health care providers in the United States 
        wrote nearly 143,000,000 prescriptions for painkillers, which 
        is 43 prescriptions per 100 people.
            (5) The amount of prescription opioids sold in the United 
        States has increased without a reported increase in pain. At 
        the same time, overdose deaths involving opioids have 
        quadrupled since 1999, with more than 932,000 people having 
        died from a drug overdose.
            (6) Although overdose death rates are beginning to see a 
        slow decline, over 106,000 people are predicted to have died of 
        drug overdose in 2022.

SEC. 3. REQUIREMENT TO REVOKE APPROVAL.

    (a) In General.--Notwithstanding any other provision of law, if the 
Secretary of Health and Human Services (referred to in this section as 
the ``Secretary'') approves an application under subsection (b) or (j) 
of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) for an opioid drug, the Secretary shall revoke the approval of 
another opioid drug previously approved under subsection (c) or (j) of 
such section 505.
    (b) Considerations.--In determining the drug for which the 
Secretary will revoke approval pursuant to subsection (a), the 
Secretary shall--
            (1) prioritize revocation of non-abuse deterrent 
        formulations of opioid drugs; and
            (2) consider the public health impact of the opioid drug 
        being on the market.
                                 &lt;all&gt;
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