Protecting Americans from Dangerous Opioids Act

118 S606 IS: Protecting Americans from Dangerous Opioids Act U.S. Senate 2023-03-01 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. II 118th CONGRESS 1st Session S. 606 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. 1. Short title This Act may be cited as the Protecting Americans from Dangerous Opioids Act . 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. 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.