[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 419 Introduced in Senate (IS)]

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116th CONGRESS
  1st Session
                                 S. 419

 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

                            February 7, 2019

  Mr. Manchin 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) Opioids killed more than 33,000 people in the United 
        States in 2015, more than any year on record. Nearly half of 
        all opioid overdose deaths involve a prescription opioid.
            (2) According to the Centers for Disease Control, 3 out of 
        4 new heroin users abused prescription opioids before moving to 
        heroin.
            (3) The United States makes up only 4.6 percent of the 
        world's population, but consumes 80 percent of its opioid pain 
        medications.
            (4) In 2012, health care providers wrote 259,000,000 
        prescriptions for painkillers, enough for every individual in 
        the United States to have a bottle of pills.
            (5) The amount of prescription opioids sold in the United 
        States has nearly quadrupled since 1999 without a reported 
        increase in pain. At the same time overdose deaths involving 
        opioids have also quadrupled since 1999.

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 such subsection (b) or 
(j).
    (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.
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