[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2510 Introduced in Senate (IS)]

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118th CONGRESS
  1st Session
                                S. 2510

  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 SENATE OF THE UNITED STATES

                             July 26, 2023

Mr. Peters (for himself, Mr. Brown, and Mrs. Blackburn) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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 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.
    (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 
        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--
                    (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 
2024.

SEC. 3. 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.
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