[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3955 Introduced in House (IH)]
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119th CONGRESS
1st Session
H. R. 3955
To improve supply chain resiliency for critical drug products with
vulnerable supply chains and ensure that reserves of critical drugs and
active pharmaceutical ingredients are maintained to prevent supply
disruptions in the event of drug shortages or public health
emergencies.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 12, 2025
Ms. Craig (for herself and Mr. Van Drew) introduced the following bill;
which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To improve supply chain resiliency for critical drug products with
vulnerable supply chains and ensure that reserves of critical drugs and
active pharmaceutical ingredients are maintained to prevent supply
disruptions in the event of drug shortages or public health
emergencies.
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 ``Rolling Active Pharmaceutical
Ingredient and Drug Reserve Act'' or the ``RAPID Reserve Act''.
SEC. 2. ROLLING ACTIVE PHARMACEUTICAL INGREDIENT AND DRUG RESERVE.
(a) In General.--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.
(b) Requirements.--
(1) In general.--An eligible entity, pursuant to a contract
or cooperative agreement under subsection (a), 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, natural
disaster, 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--
(A) give preference to eligible entities that
will--
(i) 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; or
(ii) source key starting materials or
excipients for eligible drugs domestically or
from a country that is a member of the
Organisation for Economic Cooperation and
Development; and
(B) to the greatest extent practicable, award such
contracts and cooperative agreements in a manner that
strengthens domestic manufacturing, resiliency, and
capacity of eligible drugs and their active
pharmaceutical ingredients.
(c) Additional Contract and Cooperative Agreement Terms.--
(1) In general.--Each contract or cooperative agreement
under subsection (a) 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.
(d) 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.
(e) 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
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--
(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).
(f) 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 (e)(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.
(g) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $500,000,000 for fiscal year
2026.
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