Onshoring Essential Antibiotics Act

To establish a grant program to support the manufacture and stockpiling of essential generic antibiotic drugs. 1. Short title This Act may be cited as the Onshoring Essential Antibiotics Act 2. Essential generic antibiotic program (a) Grant program (1) Establishment Not later than 60 days after the date of enactment of this Act, the Secretary shall establish a program to provide grants to manufacturers of essential generic antibiotic drugs, or the active pharmaceutical ingredient or key starting material of an essential generic antibiotic drug, to support activities described in paragraph (3). (2) Eligible entities The Secretary shall award grants under this subsection to not more than 3 manufacturers of an essential generic antibiotic drug. Each such recipient shall be a manufacturer that— (A) has implemented and maintains an effective quality management system, under parts 210 and 211 of title 21, Code of Federal Regulations (or any successor regulations); (B) has a strong record of compliance with the requirements of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 (C) uses complex pharmaceutical manufacturing to produce a finished drug product or active pharmaceutical ingredient pursuant to an application approved under section subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 (D) commits to using advanced manufacturing in its manufacturing operations; and (E) has existing manufacturing facilities and operations in the United States. (3) Use of funds A recipient of a grant under this subsection may use such grant funds to— (A) with respect to manufacturing an essential generic antibiotic drug— (i) expand, upgrade, or recommission an existing manufacturing facility located in the United States; or (ii) construct a new manufacturing facility in the United States; and (B) manufacture essential generic antibiotic drugs. (b) Use of funds To purchase essential generic antibiotic drugs for stockpiling The Secretary may use amounts appropriated under this section to purchase, store, stockpile, or disposition essential generic antibiotic drugs manufactured in the United States. (c) Definitions For purposes of this section: (1) Active pharmaceutical ingredient The term active pharmaceutical ingredient 21 U.S.C. 379j–41 (2) Essential generic antibiotic drug The term essential generic antibiotic drug 21 U.S.C. 355(j) (3) Key starting material The term key starting material (4) Secretary The term Secretary (5) United States The term United States (d) Funding For purposes of carrying out this section, there is appropriated, out of amounts in the Treasury not otherwise appropriated, $500,000,000 for fiscal year 2021, to remain available through September 30, 2023. 3. Study and report (a) In general The Secretary of Health and Human Services (referred to in this section as the Secretary (1) recommendations about which antibiotics the Secretary should prioritize for purposes of the program under section 2, based on factors that include necessity of use, vulnerability to foreign supply chain disruptions, and availability of alternatives; and (2) the expected effect of increased domestic manufacturing of drugs on drug costs to consumers. (b) Authorization To carry out this section, there is authorized to be appropriated $2,000,000 for fiscal year 2021, to remain available until September 30, 2022.

Summary: Onshoring Essential Antibiotics Act This bill requires the Department of Health and Human Services (HHS) to provide grants to up to three manufacturers of essential generic antibiotic drugs (or of the active pharmaceutical ingredient or key starting material for such a drug). Under the bill, an essential generic antibiotic drug is one that HHS deems to be medically necessary to have available at all times in adequate amounts. These grants may be used to (1) construct, expand, or upgrade a manufacturing facility in the United States; and (2) manufacture essential generic antibiotic drugs. HHS shall commission a report with (1) recommendations about which drugs should be prioritized in the grant program, and (2) an analysis of the expected effect of domestic drug manufacturing on drug costs to consumers. HHS may stockpile essential generic antibiotic drugs manufactured in the United States. The bill provides in funding for the grant program and for HHS to stockpile generic antibiotic drugs.