Protecting Americans from Dangerous Opioids Act

II 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 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 33,000 people in 8 the United States in 2015, more than any year on 9 VerDate Sep 11 2014 18:47 Feb 19, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S419.IS S419 pamtmann on DSKBFK8HB2PROD with BILLS 2 •S 419 IS record. Nearly half of all opioid overdose deaths in- 1 volve a prescription 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 SEC. 3. REQUIREMENT TO REVOKE APPROVAL. 18 (a) IN GENERAL.—Notwithstanding any other provi- 19 sion of law, if the Secretary of Health and Human Serv- 20 ices (referred to in this section as the ‘‘Secretary’’) ap- 21 proves an application under subsection (b) or (j) of section 22 505 of the Federal Food, Drug, and Cosmetic Act (21 23 U.S.C. 355) for an opioid drug, the Secretary shall revoke 24 VerDate Sep 11 2014 18:47 Feb 19, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S419.IS S419 pamtmann on DSKBFK8HB2PROD with BILLS 3 •S 419 IS the approval of another opioid drug previously approved 1 under such subsection (b) or (j). 2 (b) CONSIDERATIONS.—In determining the drug for 3 which the Secretary will revoke approval pursuant to sub- 4 section (a), the Secretary shall— 5 (1) prioritize revocation of non-abuse deterrent 6 formulations of opioid drugs; and 7 (2) consider the public health impact of the 8 opioid drug being on the market. 9 Æ VerDate Sep 11 2014 18:47 Feb 19, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\S419.IS S419 pamtmann on DSKBFK8HB2PROD with BILLS