Title: Onshoring Essential Antibiotics Act
Policy area: Health

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.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 1176 Introduced in Senate (IS)]

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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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Onshoring Essential Antibiotics 
Act''.

SEC. 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 et seq.);
                    (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'' has the meaning given such term in 
        section 744A of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 379j-41).
            (2) Essential generic antibiotic drug.--The term 
        ``essential generic antibiotic drug'' means an antibacterial or 
        antifungal drug approved by the Food and Drug Administration 
        under section 505(j) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 355(j)) that the Secretary determines to be 
        medically necessary to have available at all times in an amount 
        adequate to serve patient needs, including beta-lactams 
        (including penicillin and cephalosporin derivatives) and non-
        beta lactams (including tetracycline and aminoglycoside 
        derivatives).
            (3) Key starting material.--The term ``key starting 
        material'' means any component of a drug that the Secretary 
        determines to be critical to the safety and effectiveness of 
        the drug.
            (4) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
            (5) United states.--The term ``United States'' means the 50 
        States, the District of Columbia, territories, and Tribal 
        lands.
    (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.

SEC. 3. STUDY AND REPORT.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall enter into a 
contract with an entity under which such entity carries out a study on 
the manufacture of essential generic antibiotic drugs and issues a 
report that includes--
            (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.
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