Title: HOME Act
Policy area: Health

Summary:
Help Onshore Manufacturing Efficiencies for Drugs and Devices Act or the HOME Act
This bill contains provisions related to critical drugs and medical devices.
The bill establishes within the Department of Health and Human Services (HHS) the Center for Domestic Advanced Manufacturing of Critical Drugs and Devices. The center shall establish and implement a program to provide grants and forgivable loans to support investment in advanced manufacturing for the domestic production of critical drugs, medical devices, and active pharmaceutical ingredients.
Furthermore, a supplemental application for a critical drug approved by the Food and Drug Administration (FDA) may receive expedited review if, among other requirements, the applicant plans to produce the drug domestically after the approval of the supplemental application. (A supplemental application generally involves a change, such as a manufacturing change, to an existing application for FDA approval.)
The bill also authorizes HHS and the Department of Defense to enter into multiyear high-volume contracts to purchase critical drugs and medical devices.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3780 Introduced in Senate (IS)]

<DOC>






116th CONGRESS
  2d Session
                                S. 3780

  To encourage domestic advanced manufacturing of critical drugs and 
 devices in order to address economic, health, and security concerns, 
 combat shortages of critical drugs and devices, and promote increased 
domestic diversification of, and independence from foreign reliance on, 
            pharmaceutical and medical device supply chains.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 20, 2020

  Mr. Peters introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To encourage domestic advanced manufacturing of critical drugs and 
 devices in order to address economic, health, and security concerns, 
 combat shortages of critical drugs and devices, and promote increased 
domestic diversification of, and independence from foreign reliance on, 
            pharmaceutical and medical device supply chains.

    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 ``Help Onshore Manufacturing 
Efficiencies for Drugs and Devices Act'' or the ``HOME Act''.

SEC. 2. INVESTMENTS IN DOMESTIC ADVANCED MANUFACTURING AND 
              PREPAREDNESS.

    Part A of title III of the Public Health Service Act (42 U.S.C. 241 
et seq.) is amended by adding at the end the following:

``SEC. 310B. INVESTMENTS IN DOMESTIC ADVANCED MANUFACTURING FOR 
              CRITICAL DRUGS AND DEVICES.

    ``(a) Establishment.--There is established within the Office of the 
Assistant Secretary for Preparedness and Response of the Department of 
Health and Human Services, the `Center for Domestic Advanced 
Manufacturing of Critical Drugs and Devices' (referred to in this 
section as the `Center').
    ``(b) Purpose.--The purpose of the Center for Domestic Advanced 
Manufacturing of Critical Drugs and Devices shall be to implement a 
program to invest in the advanced manufacturing for critical drugs and 
devices, and to increase domestic production of critical drugs and 
devices, throughout the United States.
    ``(c) Director.--The Center shall be headed by a Director (referred 
to in this section as the `Director') who shall be appointed by the 
Secretary and to whom the Secretary shall delegate such functions and 
authorities as may be necessary to implement this section.
    ``(d) Program.--
            ``(1) In general.--The Center for Domestic Advanced 
        Manufacturing of Critical Drugs and Devices shall--
                    ``(A) not later than 18 months after the date of 
                enactment of this section--
                            ``(i) establish an advisory board of 
                        experts from governmental entities, 
                        manufacturers, other private industry entities, 
                        nonprofit entities, and institutions of higher 
                        education, and any other entity as determined 
                        by the Center; and
                            ``(ii) compile a list of critical drugs and 
                        devices that should be prioritized for domestic 
                        advanced manufacturing and increased domestic 
                        production under the program described in 
                        paragraph (2), based on reports to the 
                        Secretary under sections 506C and 506J of the 
                        Federal Food, Drug, and Cosmetic Act, the drug 
                        shortage list under section 506E of such Act, 
                        the device shortage list under section 506J(g) 
                        of such Act, and the annual risk assessments 
                        described in section 5 of the HOME Act, if 
                        available, and update such list quarterly;
                    ``(B) establish and oversee the grant and 
                forgivable loan program described in paragraph (2), 
                including by establishing requirements for 
                participation in such program, including--
                            ``(i) target goals to substantially 
                        increase advanced manufacturing production for 
                        critical drugs and devices within the United 
                        States; and
                            ``(ii) conditioning the receipt of funding 
                        under such program on an entity's agreement to 
                        commercially distribute the drug or device in 
                        the United States; and
                    ``(C) review the effects of the program described 
                in paragraph (2) on the percentage change in domestic 
                manufacturing of critical drugs, devices, and active 
                pharmaceutical ingredients.
            ``(2) Grant and forgivable loan program.--
                    ``(A) In general.--The Center for Domestic Advanced 
                Manufacturing of Critical Drugs and Devices shall 
                establish a grant and forgivable loan program in order 
                to support investment in--
                            ``(i) advanced manufacturing and facilities 
                        upgrades for the domestic production of 
                        critical drugs, devices, and active 
                        pharmaceutical ingredients; and
                            ``(ii) increased domestic production and 
                        diversification of critical drugs, devices, and 
                        active pharmaceutical ingredients.
                    ``(B) Eligible entities.--
                            ``(i) In general.--To be eligible to 
                        receive a grant or forgivable loan under this 
                        paragraph, an entity shall meet the 
                        requirements established under paragraphs 
                        (1)(A)(ii) and (1)(B) and such criteria as the 
                        Center shall develop and, as applicable--
                                    ``(I) with respect to a critical 
                                drug, shall be the holder of an 
                                application approved under section 505 
                                of the Federal Food, Drug, and Cosmetic 
                                Act or section 351 of this Act, or a 
                                contract manufacturer of the drug for 
                                such holder of an approved application;
                                    ``(II) with respect to an active 
                                pharmaceutical ingredient, shall be the 
                                manufacturer of an active 
                                pharmaceutical ingredient of a drug 
                                approved under section 505 of the 
                                Federal Food, Drug, and Cosmetic Act or 
                                section 351 of this Act;
                                    ``(III) with respect to a critical 
                                device, shall have received approval 
                                under section 515 of the Federal Food, 
                                Drug, and Cosmetic Act, clearance under 
                                section 510(k) of such Act (or be 
                                exempt from the requirements of such 
                                section 510(k)), or authorization under 
                                section 513(f)(2) of such Act, or shall 
                                be a contract manufacturer of the 
                                device for such an entity; or
                                    ``(IV) with respect to a drug or 
                                device, shall have submitted an 
                                application under section 505 or 515 of 
                                the Federal Food, Drug, and Cosmetic 
                                Act or under section 351 of this Act, a 
                                report under section 510(k), or a 
                                request under section 513(f)(2).
                            ``(ii) Priority.--In awarding grants and 
                        forgivable loans under this paragraph the 
                        Center for Domestic Advanced Manufacturing of 
                        Critical Drugs and Devices shall give 
                        priority--
                                    ``(I) in the case of manufacturers 
                                of drugs or active pharmaceutical 
                                ingredients, to entities--
                                            ``(aa) described in 
                                        subclauses (I) and (II) of 
                                        clause (i); and
                                            ``(bb) whose application 
                                        for an award under this 
                                        paragraph relates to a drug 
                                        that was approved under section 
                                        505(j) of the Federal Food, 
                                        Drug, and Cosmetic Act; and
                                    ``(II) in the case of manufacturers 
                                of devices, to entities described in 
                                clause (i)(III).
                    ``(C) Use of funds.--Awards received under this 
                paragraph shall be used for the advanced manufacturing 
                and increased production of critical drugs and devices 
                in the United States.
                    ``(D) Forgivable loans.--The Center may award 
                forgivable loans under this paragraph under which a 
                recipient shall receive a loan and be eligible for 
                forgiveness of indebtedness on such loan, under such 
                conditions for receipt and forgiveness as the Center 
                may establish.
                    ``(E) Grants.--The Center may award grants under 
                this section, which shall be conditioned upon the 
                recipient matching Federal funds so awarded.
                    ``(F) Funding.--Out of amounts made available to 
                carry out this section, the Secretary shall allocate 
                $500,000,000 toward awards of forgivable loans and 
                grants under this paragraph.
    ``(e) Annual Reporting.--The Secretary shall submit to the relevant 
committees of Congress annual reports on the program under this 
section. At a minimum, each such report shall--
            ``(1) identify the list of critical drugs and devices under 
        subsection (d)(1)(A)(ii) and account for any alterations in the 
        list;
            ``(2) describe the participants in the program under 
        subsection (d)(2) and criteria for eligibility for such 
        participation;
            ``(3) address target goals for substantially increased 
        advanced manufacturing production for critical drugs and 
        devices; and
            ``(4) review the percentage change in domestic 
        manufacturing of critical drugs, devices, and active 
        pharmaceutical ingredients since the most recent report.
    ``(f) Interagency Cooperation.--
            ``(1) In general.--In carrying out activities under this 
        section, the Center is authorized, subject to paragraph (2), to 
        enter into interagency agreements and other collaborative 
        undertakings with other Federal agencies.
            ``(2) Limitation.--An agreement or undertaking under this 
        subsection shall not authorize another agency to exercise the 
        authorities provided by this section.
    ``(g) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated such funds as may be necessary, 
for each of fiscal years 2021 through 2031.
    ``(h) Definitions.--In this section--
            ``(1) the terms `drug' and `device' have the meanings given 
        such terms in section 201 of the Federal Food, Drug, and 
        Cosmetic Act;
            ``(2) the term `institution of higher education' has the 
        meaning given such term in section 101(a) of the Higher 
        Education Act of 1965; and
            ``(3) the term `relevant committees of Congress' means the 
        Committee on Homeland Security and Governmental Affairs, the 
        Committee on Health, Education, Labor, and Pensions, and the 
        Committee on Armed Services of the Senate and the Committee on 
        Homeland Security, the Committee on Energy and Commerce, and 
        the Committee on Armed Services of the House of 
        Representatives.''.

SEC. 3. EXPEDITED REVIEW OF CERTAIN SUPPLEMENTAL APPLICATIONS.

    Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356) is amended by adding at the end the following:
    ``(i) Expedited Review of Certain Supplemental Applications.--
            ``(1) In general.--The holder of an application approved 
        under section 505 of this Act or license under section 351 of 
        the Public Health Service Act who submits a supplemental 
        application with respect to such application or license may 
        request an expedited review of such supplemental application 
        under this subsection.
            ``(2) Application.--To be eligible for expedited review 
        under this subsection, the holder of the approved application 
        or license with respect to a drug included on the most recent 
        list of critical drugs and devices compiled under section 
        310B(d)(1)(A)(ii) of the Public Health Service Act, shall 
        demonstrate in the supplemental application that--
                    ``(A) approval of such supplemental application 
                would enable the incorporation of a manufacturing 
                change that is intended to enhance drug quality, 
                increase domestic manufacturing of the drug, or 
                incorporate the use of advanced manufacturing; and
                    ``(B) the applicant's plan for producing the drug 
                domestically after approval of the supplemental 
                application.
            ``(3) Review by secretary.--If the Secretary determines, 
        after preliminary evaluation of a supplemental application, 
        that the application demonstrates that the manufacturing change 
        would enhance the ability of the holder of the application to 
        domestically manufacture a drug on the list of critical drugs 
        and devices described in paragraph (2), the Secretary shall 
        evaluate for filing, and may commence review of portions of, 
        such supplemental application before the sponsor submits a 
        complete application. The Secretary shall commence such review 
        only if the applicant provides a schedule for submission of 
        information necessary to make the application complete.''.

SEC. 4. LONG-TERM, HIGH-VOLUME CONTRACTS TO PURCHASE CRITICAL DRUGS AND 
              DEVICES.

    (a) Contracting Goals.-- In order to further the needs of the 
Department of Health and Human Services and the Department of Defense, 
invest in preparedness and the strategic national stockpile, and 
mitigate drug and device shortages, each of the Secretary of Health and 
Human Services and the Assistant Secretary of Defense for Health 
Affairs may enter into contracts to purchase a drug or device included 
on the list of critical drugs and devices compiled under section 
310B(d)(1)(A)(ii) of the Public Health Service Act (as added by section 
2), including multi-year, high-volume contracts, as set forth in 
subsection (b), and otherwise in accordance with procurement laws and 
regulations.
    (b) Responsibility Determinations.--For purposes of meeting the 
goals under subsection (a), a contracting officer of the Department of 
Health and Human Services or the Department of Defense may give 
preference and award a contract to a program participant under section 
310B(d)(2) of the Public Health Service Act (as added by section 2), 
if--
            (1) the program participant is determined by the 
        contracting officer, in consultation with the Center for 
        Domestic Advanced Manufacturing of Critical Drugs and Devices 
        with respect to the participant's performance in the program 
        under section 310B(d)(2) of the Public Health Service Act, to 
        be a responsible source with respect to performance of the 
        contract; and
            (2) in the estimation of the contracting officer, the 
        contract award can be made at a fair and reasonable price that 
        offers best value to the United States.

SEC. 5. ANNUAL RISK ASSESSMENT.

    (a) In General.--Not later than 1 year after the date of enactment 
of this Act, and annually thereafter, the Secretary of Homeland 
Security, the Secretary of Health and Human Services, and the Secretary 
of Defense shall each conduct separate independent risk assessments of 
the medical supply chain and report to the relevant committees of 
Congress on the findings of such assessments. At a minimum, each risk 
assessment shall--
            (1) identify drugs and devices critical to each agency in 
        responding to a public health emergency, biological or chemical 
        threat, or other national security threat;
            (2) identify the drugs and devices identified under 
        paragraph (1) for which there is a single manufacturer or 
        distributer in the United States;
            (3) list the drugs and devices identified under paragraph 
        (1) that are sourced exclusively from foreign sources;
            (4) assess current domestic manufacturing capability with 
        respect to drugs and devices identified under paragraph (1), 
        including advanced manufacturing capabilities; and
            (5) identify critical vulnerabilities and establish 
        contingency plans in the event of a public health emergency, 
        biological or chemical threat, or other national security 
        threat.
    (b) Risk Assessment Report Conclusions.--Each risk assessment of 
each secretary under subsection (a) shall indicate, at a minimum--
            (1) the existing statutory authorities the department has 
        to address public health or national security risks that may 
        arise as a result of vulnerabilities in the medical supply 
        chain;
            (2) any deficiencies, lack of authorities, or limitations 
        in policy or process that limit the department's ability to 
        address vulnerabilities identified in the applicable risk 
        assessment; and
            (3) the secretary's plans to address drug and device 
        shortages, control costs, and prepare for public health 
        emergencies, biological or chemical threats, and other national 
        security threats.
    (c) Review by Secretaries.--The Secretary of Homeland Security, the 
Secretary of Health and Human Services, and the Secretary of Defense, 
in providing the risk assessments under subsection (a) may consult with 
each other, as appropriate, regarding any similarities in 
vulnerabilities experienced by each such secretary and any coordination 
among the secretaries that may address such vulnerabilities.
    (d) Definitions.--In this section--
            (1) the terms ``device'' and ``drug'' have the meanings 
        given such terms in section 201 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 321); and
            (2) the term ``relevant committees of Congress'' means the 
        Committee on Homeland Security and Governmental Affairs, the 
        Committee on Health, Education, Labor, and Pensions, and the 
        Committee on Armed Services of the Senate and the Committee on 
        Homeland Security, the Committee on Energy and Commerce, and 
        the Committee on Armed Services of the House of 
        Representatives.
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