Onshoring Essential Antibiotics Act

II 117TH CONGRESS 1ST SESSION S. 1176 To establish a grant program to support the manufacture and stockpiling of essential generic antibiotic drugs. IN THE SENATE OF THE UNITED STATES APRIL 15, 2021 Ms. SMITH (for herself and Mr. CASSIDY) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To establish a grant program to support the manufacture and stockpiling of essential generic antibiotic drugs. 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 ‘‘Onshoring Essential 4 Antibiotics Act’’. 5 SEC. 2. ESSENTIAL GENERIC ANTIBIOTIC PROGRAM. 6 (a) GRANT PROGRAM.— 7 (1) ESTABLISHMENT.—Not later than 60 days 8 after the date of enactment of this Act, the Sec- 9 retary shall establish a program to provide grants to 10 VerDate Sep 11 2014 18:40 May 12, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1176.IS S1176 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 1176 IS manufacturers of essential generic antibiotic drugs, 1 or the active pharmaceutical ingredient or key start- 2 ing material of an essential generic antibiotic drug, 3 to support activities described in paragraph (3). 4 (2) ELIGIBLE ENTITIES.—The Secretary shall 5 award grants under this subsection to not more than 6 3 manufacturers of an essential generic antibiotic 7 drug. Each such recipient shall be a manufacturer 8 that— 9 (A) has implemented and maintains an ef- 10 fective quality management system, under parts 11 210 and 211 of title 21, Code of Federal Regu- 12 lations (or any successor regulations); 13 (B) has a strong record of compliance with 14 the requirements of the Federal Food, Drug, 15 and Cosmetic Act (21 U.S.C. 301 et seq.); 16 (C) uses complex pharmaceutical manufac- 17 turing to produce a finished drug product or ac- 18 tive pharmaceutical ingredient pursuant to an 19 application approved under section subsection 20 (c) or (j) of section 505 of the Federal Food, 21 Drug, and Cosmetic Act (21 U.S.C. 355); 22 (D) commits to using advanced manufac- 23 turing in its manufacturing operations; and 24 VerDate Sep 11 2014 18:40 May 12, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1176.IS S1176 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 1176 IS (E) has existing manufacturing facilities 1 and operations in the United States. 2 (3) USE OF FUNDS.—A recipient of a grant 3 under this subsection may use such grant funds to— 4 (A) with respect to manufacturing an es- 5 sential generic antibiotic drug— 6 (i) expand, upgrade, or recommission 7 an existing manufacturing facility located 8 in the United States; or 9 (ii) construct a new manufacturing fa- 10 cility in the United States; and 11 (B) manufacture essential generic anti- 12 biotic drugs. 13 (b) USE OF FUNDS TO PURCHASE ESSENTIAL GE- 14 NERIC ANTIBIOTIC DRUGS FOR STOCKPILING.—The Sec- 15 retary may use amounts appropriated under this section 16 to purchase, store, stockpile, or disposition essential ge- 17 neric antibiotic drugs manufactured in the United States. 18 (c) DEFINITIONS.—For purposes of this section: 19 (1) ACTIVE PHARMACEUTICAL INGREDIENT.— 20 The term ‘‘active pharmaceutical ingredient’’ has the 21 meaning given such term in section 744A of the 22 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 23 379j–41). 24 VerDate Sep 11 2014 18:40 May 12, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1176.IS S1176 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 1176 IS (2) ESSENTIAL GENERIC ANTIBIOTIC DRUG.— 1 The term ‘‘essential generic antibiotic drug’’ means 2 an antibacterial or antifungal drug approved by the 3 Food and Drug Administration under section 505(j) 4 of the Federal Food, Drug, and Cosmetic Act (21 5 U.S.C. 355(j)) that the Secretary determines to be 6 medically necessary to have available at all times in 7 an amount adequate to serve patient needs, includ- 8 ing beta-lactams (including penicillin and 9 cephalosporin derivatives) and non-beta lactams (in- 10 cluding tetracycline and aminoglycoside derivatives). 11 (3) KEY STARTING MATERIAL.—The term ‘‘key 12 starting material’’ means any component of a drug 13 that the Secretary determines to be critical to the 14 safety and effectiveness of the drug. 15 (4) SECRETARY.—The term ‘‘Secretary’’ means 16 the Secretary of Health and Human Services. 17 (5) UNITED STATES.—The term ‘‘United 18 States’’ means the 50 States, the District of Colum- 19 bia, territories, and Tribal lands. 20 (d) FUNDING.—For purposes of carrying out this 21 section, there is appropriated, out of amounts in the 22 Treasury not otherwise appropriated, $500,000,000 for 23 fiscal year 2021, to remain available through September 24 30, 2023. 25 VerDate Sep 11 2014 18:40 May 12, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1176.IS S1176 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 1176 IS SEC. 3. STUDY AND REPORT. 1 (a) IN GENERAL.—The Secretary of Health and 2 Human Services (referred to in this section as the ‘‘Sec- 3 retary’’) shall enter into a contract with an entity under 4 which such entity carries out a study on the manufacture 5 of essential generic antibiotic drugs and issues a report 6 that includes— 7 (1) recommendations about which antibiotics 8 the Secretary should prioritize for purposes of the 9 program under section 2, based on factors that in- 10 clude necessity of use, vulnerability to foreign supply 11 chain disruptions, and availability of alternatives; 12 and 13 (2) the expected effect of increased domestic 14 manufacturing of drugs on drug costs to consumers. 15 (b) AUTHORIZATION.—To carry out this section, 16 there is authorized to be appropriated $2,000,000 for fis- 17 cal year 2021, to remain available until September 30, 18 2022. 19 Æ VerDate Sep 11 2014 18:40 May 12, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\S1176.IS S1176 pamtmann on DSKBC07HB2PROD with BILLS