[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.
                                 ______