119-hr3955

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3955 Introduced in House

    (IH) ]

<DOC>

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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