| 1 | 1 | | II |
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| 2 | 2 | | 118THCONGRESS |
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| 3 | 3 | | 1 |
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| 4 | 4 | | STSESSION S. 3557 |
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| 5 | 5 | | To require the Secretary of Health and Human Services to prepare a report |
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| 6 | 6 | | that outlines a plan for completing a review of approved opioid analgesic |
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| 7 | 7 | | drugs that considers the public health effects of such opioid drugs. |
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| 8 | 8 | | IN THE SENATE OF THE UNITED STATES |
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| 9 | 9 | | DECEMBER19, 2023 |
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| 10 | 10 | | Mr. M |
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| 11 | 11 | | URPHY(for himself and Mr. BRAUN) introduced the following bill; which |
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| 12 | 12 | | was read twice and referred to the Committee on Health, Education, |
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| 13 | 13 | | Labor, and Pensions |
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| 14 | 14 | | A BILL |
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| 15 | 15 | | To require the Secretary of Health and Human Services |
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| 16 | 16 | | to prepare a report that outlines a plan for completing |
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| 17 | 17 | | a review of approved opioid analgesic drugs that con- |
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| 18 | 18 | | siders the public health effects of such opioid drugs. |
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| 19 | 19 | | Be it enacted by the Senate and House of Representa-1 |
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| 20 | 20 | | tives of the United States of America in Congress assembled, 2 |
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| 21 | 21 | | SECTION 1. REVIEW OF OPIOID DRUGS AND ACTIONS. 3 |
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| 22 | 22 | | Not later than one year after the date of enactment 4 |
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| 23 | 23 | | of this Act, the Secretary of Health and Human Services 5 |
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| 24 | 24 | | (referred to in this section as the ‘‘Secretary’’) shall pub-6 |
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| 25 | 25 | | lish on the website of the Food and Drug Administration 7 |
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| 26 | 26 | | (referred to in this section as the ‘‘FDA’’) a report that 8 |
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| 27 | 27 | | VerDate Sep 11 2014 01:48 Dec 20, 2023 Jkt 049200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3557.IS S3557 |
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| 28 | 28 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 2 |
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| 29 | 29 | | •S 3557 IS |
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| 30 | 30 | | outlines a plan for completing a review of opioid analgesic 1 |
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| 31 | 31 | | drugs that are approved under section 505 of the Federal 2 |
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| 32 | 32 | | Food, Drug, and Cosmetic Act (21 U.S.C. 355) that con-3 |
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| 33 | 33 | | siders the public health effects of such opioid drugs as part 4 |
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| 34 | 34 | | of the benefit-risk assessment, and that addresses the ac-5 |
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| 35 | 35 | | tivities of the FDA that relate to increasing the develop-6 |
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| 36 | 36 | | ment of non-addictive medical products intended to treat 7 |
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| 37 | 37 | | pain or addiction. Such report shall include— 8 |
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| 38 | 38 | | (1) an opportunity for public input concerning 9 |
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| 39 | 39 | | the regulation by the FDA of opioid analgesic drugs, 10 |
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| 40 | 40 | | including scientific evidence that relates to condi-11 |
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| 41 | 41 | | tions of use, safety, or benefit-risk assessment (in-12 |
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| 42 | 42 | | cluding consideration of the public health effects) of 13 |
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| 43 | 43 | | such opioid drugs; 14 |
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| 44 | 44 | | (2) an update on the actions taken by the FDA 15 |
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| 45 | 45 | | to review the effectiveness, safety, benefit-risk profile 16 |
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| 46 | 46 | | (which may include public health effects), and use of 17 |
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| 47 | 47 | | approved opioid analgesic drugs; 18 |
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| 48 | 48 | | (3) a timeline for an assessment of the potential 19 |
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| 49 | 49 | | need, as appropriate, for labeling changes, revised or 20 |
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| 50 | 50 | | additional postmarketing requirements, enforcement 21 |
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| 51 | 51 | | actions, or withdrawals for opioid analgesic drugs; 22 |
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| 52 | 52 | | (4) an overview of the steps that the FDA has 23 |
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| 53 | 53 | | taken to support the development and approval of 24 |
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| 54 | 54 | | non-addictive medical products intended to treat 25 |
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| 55 | 55 | | VerDate Sep 11 2014 01:48 Dec 20, 2023 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3557.IS S3557 |
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| 56 | 56 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 3 |
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| 57 | 57 | | •S 3557 IS |
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| 58 | 58 | | pain or addiction, and actions planned to further 1 |
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| 59 | 59 | | support the development and approval of such prod-2 |
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| 60 | 60 | | ucts; and 3 |
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| 61 | 61 | | (5) an overview of the consideration by the 4 |
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| 62 | 62 | | FDA of clinical trial methodologies for analgesic 5 |
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| 63 | 63 | | drugs, including the enriched enrollment randomized 6 |
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| 64 | 64 | | withdrawal methodology, and the benefits and draw-7 |
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| 65 | 65 | | backs associated with different trial methodologies 8 |
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| 66 | 66 | | for such drugs, incorporating any public input re-9 |
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| 67 | 67 | | ceived under paragraph (1). 10 |
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| 68 | 68 | | Æ |
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| 69 | 69 | | VerDate Sep 11 2014 01:48 Dec 20, 2023 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\S3557.IS S3557 |
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| 70 | 70 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB |
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