Protecting Americans from Dangerous Opioids Act

II 117TH CONGRESS 1ST SESSION S. 1434 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 APRIL 28, 2021 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Protecting Americans 4 from Dangerous Opioids Act’’. 5 SEC. 2. FINDINGS. 6 Congress finds as follows: 7 (1) Opioids killed more than 36,000 people in 8 the United States in 2019, more than any year on 9 record. In 2019, nearly half of all drug overdose 10 VerDate Sep 11 2014 03:26 May 22, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1434.IS S1434 kjohnson on DSK79L0C42PROD with BILLS 2 •S 1434 IS deaths involved a prescription opioid or synthetic 1 opioid. 2 (2) According to the Centers for Disease Con- 3 trol, 3 out of 4 new heroin users abused prescription 4 opioids before moving to heroin. 5 (3) The United States makes up only 4.6 per- 6 cent of the world’s population, but consumes 80 per- 7 cent of its opioid pain medications. 8 (4) In 2012, health care providers wrote 9 259,000,000 prescriptions for painkillers, enough for 10 every individual in the United States to have a bottle 11 of pills. 12 (5) The amount of prescription opioids sold in 13 the United States has nearly quadrupled since 1999 14 without a reported increase in pain. At the same 15 time overdose deaths involving opioids have also 16 quadrupled since 1999. 17 (6) In 2020, over 90,000 people are predicted 18 to have died of drug overdose, the highest number 19 on record. 20 SEC. 3. REQUIREMENT TO REVOKE APPROVAL. 21 (a) IN GENERAL.—Notwithstanding any other provi- 22 sion of law, if the Secretary of Health and Human Serv- 23 ices (referred to in this section as the ‘‘Secretary’’) ap- 24 proves an application under subsection (b) or (j) of section 25 VerDate Sep 11 2014 03:26 May 22, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1434.IS S1434 kjohnson on DSK79L0C42PROD with BILLS 3 •S 1434 IS 505 of the Federal Food, Drug, and Cosmetic Act (21 1 U.S.C. 355) for an opioid drug, the Secretary shall revoke 2 the approval of another opioid drug previously approved 3 under such subsection (b) or (j). 4 (b) CONSIDERATIONS.—In determining the drug for 5 which the Secretary will revoke approval pursuant to sub- 6 section (a), the Secretary shall— 7 (1) prioritize revocation of non-abuse deterrent 8 formulations of opioid drugs; and 9 (2) consider the public health impact of the 10 opioid drug being on the market. 11 Æ VerDate Sep 11 2014 03:26 May 22, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\S1434.IS S1434 kjohnson on DSK79L0C42PROD with BILLS