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