[Congressional Record Volume 170, Number 115 (Thursday, July 11, 2024)]
[Senate]
[Pages S4774-S4775]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 2460. Mr. PETERS (for himself, Mrs. Blackburn, and Mr. Brown)
submitted an amendment intended to be proposed by him to the bill S.
4638, to authorize appropriations for fiscal year 2025 for military
activities of the Department of Defense, for military construction, and
for defense activities of the Department of Energy, to prescribe
military personnel strengths for such fiscal year, and for other
purposes; which was ordered to lie on the table; as follows:
At the end of subtitle H of title X, insert the following:
SEC. 10__. ROLLING ACTIVE PHARMACEUTICAL INGREDIENT AND DRUG
RESERVE.
(a) Short Title.--This section may be cited as the
``Rolling Active Pharmaceutical Ingredient and Drug Reserve
Act'' or the ``RAPID Reserve Act''.
(b) Rolling Active Pharmaceutical Ingredient and Drug
Reserve.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall
award contracts or cooperative agreements to eligible
entities with respect to drugs and active pharmaceutical
ingredients of such drugs that the Secretary determines to be
critical and to have vulnerable supply chains. The Secretary
shall publish the list of such drugs and active
pharmaceutical ingredients of such drugs.
(c) Requirements.--
(1) In general.--An eligible entity, pursuant to a contract
or cooperative agreement under subsection (b), shall agree
to--
(A) maintain, in a satisfactory domestic establishment
registered under section 510(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360(b)) or in a satisfactory
foreign establishment registered under section 510(i) of such
Act that is located in a country that is a member of the
Organisation for Economic Cooperation and Development, which
may be an establishment owned and operated by the entity, or
by a wholesaler, distributor, or other third-party under
contract with the entity, a 6-month reserve, or other
reasonable quantity, as determined by the Secretary, of--
(i) the active pharmaceutical ingredient of the eligible
drug specified in the contract or cooperative agreement,
which reserve shall be regularly replenished with a recently
manufactured supply of such ingredient; and
(ii) the finished eligible drug product specified in the
contract or cooperative agreement, which reserve shall be
regularly replenished with a recently manufactured supply of
such product;
(B) implement production of the eligible drug or an active
pharmaceutical ingredient of the eligible drug, at the
direction of the Secretary, under the terms of, and in such
quantities as specified in, the contract or cooperative
agreement; and
(C) enter into an arrangement with the Secretary under
which the eligible entity--
(i) agrees to transfer a portion, as determined necessary,
of the reserve of active pharmaceutical ingredient maintained
pursuant to subparagraph (A)(i) to another drug manufacturer
in the event that the Secretary determines there to be a need
for additional finished eligible drug product and such
eligible entity is unable to use the reserve of active
pharmaceutical ingredient to manufacture a sufficient supply
of such drug product; and
(ii) permits the Secretary to direct allocation of the
reserve of active pharmaceutical ingredient so maintained in
the event of a public health emergency or chemical,
biological, radiological, or nuclear threat.
(2) Guidance.--Not later than 180 days after the date of
enactment of this Act, the Secretary, in coordination with
the Commissioner of Food and Drugs, shall issue guidance on--
(A) the factors the Secretary will use to determine which
eligible drugs, or active pharmaceutical ingredient of such
drugs, have vulnerable supply chains and how a contract or
cooperative agreement would help minimize the vulnerability
or vulnerabilities identified;
(B) the factors the Secretary will consider in determining
eligibility of an entity to participate in the program under
this section, which shall include an entity's commitment to
quality systems, including strong manufacturing
infrastructure, reliable processes, and trained staff, as
well as the entity's commitment to domestic manufacturing
capacity and surge capacity, as appropriate; and
(C) requirements for entities receiving an award under this
section, including the extent of excess manufacturing
capacity the manufacturers will be required to generate, the
amount of redundancy required, and requirements relating to
advanced quality systems.
(3) Preference.--In awarding contracts and cooperative
agreements under subsection (a), the Secretary shall give
preference to eligible entities that will carry out the
requirements of paragraph (1) through one or more domestic
establishments registered under section 510(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360(b)) capable of
manufacturing the eligible drug. To the greatest extent
practicable, the Secretary shall award contracts and
cooperative agreements with manufacturers in a manner that
strengthens domestic manufacturing, resiliency, and capacity
of eligible drugs and their active pharmaceutical
ingredients.
(d) Additional Contract and Cooperative Agreement Terms.--
(1) In general.--Each contract or cooperative agreement
under subsection (b) shall be subject to such terms and
conditions as the Secretary may specify, including terms and
conditions with respect to procurement, maintenance, storage,
testing, and delivery of drugs, in alignment with inventory
management and other applicable best practices, under such
contract or cooperative agreement, which may consider, as
appropriate, costs of transporting and handling such drugs.
(2) Terms concerning the acquisition, construction,
alteration, or renovation of establishments.--Notwithstanding
section 6303 of title 41, United States Code, the Secretary
may award a contract or cooperative agreement under this
section to support the acquisition, construction, alteration,
or renovation of non-Federally owned establishments--
(A) as determined necessary to carry out or improve
preparedness and response capability at the State and local
level; or
(B) for the production of drugs, devices, and supplies
where the Secretary determines that such a contract or
cooperative agreement is necessary to ensure sufficient
amounts of such drugs, devices, and supplies.
(e) Requirements in Awarding Contracts.--To the greatest
extent practicable, the Secretary shall award contracts and
cooperative agreements under this section in a manner that--
(1) maximizes quality, minimizes cost, minimizes
vulnerability of the United States to severe shortages or
disruptions for eligible drugs and their active
pharmaceutical ingredients, gives preference to domestic
manufacturers, and encourages competition in the marketplace;
and
(2) increases domestic production surge capacity and
reserves of domestic-based manufacturing establishments for
critical drugs and active pharmaceutical ingredients of such
drugs.
(f) Definitions.--In 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) Drug.--The term ``drug'' has the meaning given such
term in section 201(g) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(g)).
(3) Drug shortage; shortage.--The term ``drug shortage'' or
``shortage'' has the meaning given such term in section 506C
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c).
(4) Eligible drug.--The term ``eligible drug'' means a
drug, as determined by the Secretary, in coordination with
the with Assistant Secretary for Preparedness and Response,
the Director of the Centers for Disease Control and
Prevention, and the Commissioner of Food and Drugs--
(A) that is approved under section 505(j) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) or licensed
under section 351(k) of the Public Health Service Act (42
U.S.C. 262(k));
(B)(i) that is reasonably likely to be required to respond
to a public health emergency or to a chemical, biological,
radiological, or nuclear threat; or
(ii) the shortage of which would pose a significant threat
to the United States health care system or at-risk
populations; and
(C) that has a vulnerable supply chain, such as a
geographic concentration of manufacturing, poor quality or
safety issues, complex manufacturing or chemistry, or few
manufacturers.
(5) Eligible entity.--The term ``eligible entity'' means a
person that--
[[Page S4775]]
(A)(i) is the holder of an approved application under
subsection (j) of section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) or subsection (k) of section 351
of the Public Health Service Act (42 U.S.C. 262) for an
eligible drug;
(ii) maintains at least one domestic establishment
registered under section 510(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360(b)) or one foreign
establishment registered under section 510(i) of such Act
that is located in a country that is a member of the
Organisation for Economic Cooperation and Development that is
capable of manufacturing the eligible drug; and
(iii) has a strong record of good manufacturing practices
of drugs;
(B)(i) is a manufacturer of an active pharmaceutical
ingredient for an eligible drug, in partnership with an
entity that meets the requirements of subparagraph (A);
(ii) maintains at least one domestic establishment
registered under section 510(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360(b)) or one foreign
establishment registered under section 510(i) of such Act
that is located in a country that is a member of the
Organisation for Economic Cooperation and Development that is
capable of manufacturing the active pharmaceutical
ingredient; and
(iii) has a strong record of good manufacturing practices
of active pharmaceutical ingredients; or
(C) is a distributor or wholesaler of an eligible drug, in
partnership with an entity that meets the requirements of
subparagraph (A).
(g) Reports to Congress.--Not later than 2 years after the
date on which the first award is made under this section, and
every 2 years thereafter, the Secretary shall submit a report
to Congress detailing--
(1) the list of drugs determined to be eligible drugs, as
described in subsection (f)(2), and the rationale behind
selecting each such drug; and
(2) an update on the effectiveness of the program under
this section, in a manner that does not compromise national
security.
(h) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $500,000,000
for fiscal year 2024.
SEC. 10__. GAO REPORT.
Not later than 18 months after the date of enactment of
this Act, the Comptroller General of the United States
shall--
(1) examine, such as through a survey or other means,
excess or underutilized domestic manufacturing capacity for
critical drugs and active pharmaceutical ingredients of such
drugs, including capacity to manufacture different dosage
forms, such as oral tablets and sterile injectable drugs, and
the capacity to manufacture drugs with various
characteristics, such as cytotoxic drugs and drugs requiring
lyophilization; and
(2) prepare and submit a report to the Committee on
Homeland Security and Governmental Affairs and the Committee
on Health, Education, Labor, and Pensions of the Senate and
the Committee on Homeland Security and the Committee on
Energy and Commerce of the House of Representatives that--
(A) includes--
(i) the results of the survey under paragraph (1);
(ii) an assessment of projected costs of utilizing and
expanding existing domestic manufacturing capabilities and
policies, as of the date of the report, that may help
establish or strengthen domestic manufacturing capacity for
key starting materials, excipients, active pharmaceutical
ingredients, and finished dosage manufacturing
establishments; and
(iii) an evaluation of policies designed to invest in
advanced domestic manufacturing capabilities and capacity for
critical active pharmaceutical ingredients and drug products;
and
(B) shall be publicly available in an unclassified form,
but may include a classified annex containing any information
that the Comptroller General determines to be sensitive.
______