Sec. 3. Establishment of the strategic active pharmaceutical ingredient reserve
2,151 words·~10 min read·
/bill/117/hr/5388/ih/section-3A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Part B of title III of the Public Health Service Act ( 42 U.S.C. 243 et seq. ), as amended by section 2, is further amended by inserting after section 319N the following: Not later than 90 days after the date of enactment of the Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines Act of 2021 , the Secretary, in consultation with the Assistant Secretary for Preparedness and Response, the Director of the Centers for Disease Control and Prevention, the Commissioner of Food and Drugs, and the Director of the Biomedical Advanced Research and Development Authority, shall prepare and submit to Congress a Strategic Active Pharmaceutical Ingredient Reserve Plan (referred to in this section as the Plan ) in accordance with subsection (b), which shall be used by the Secretary in establishing and maintaining the Strategic Active Pharmaceutical Ingredient Reserve described in subsection (c).
The Secretary shall update the plan annually and, by not later than June 1 of each year, submit the updated plan to the applicable committees of Congress. The Secretary shall ensure that any submission of the plan (including any update to the plan) to the applicable committees of Congress is in a manner that does not compromise national security. Information in the plan that, in the judgment of the Secretary, would reveal public health vulnerabilities shall be exempt from disclosure under section 552(b)(3) of title 5, United States Code.
The Plan required under subsection
(a)shall— detail the design, construction, and filling of the storage and related facilities comprising the Strategic Active Pharmaceutical Ingredient Reserve described in subsection
(c)(referred to in this section as the Reserve ); detail the requirements for maintaining the Reserve described in subsection (c), including— storage and testing requirements, consistent with parts 210 and 211 of title 21, Code of Federal Regulations, or any successor regulation; and any specific criteria agreed to by the Secretary and the manufacturer of the essential generic medicine using the active pharmaceutical ingredient or key starting material; be designed to minimize the impact of any interruption or reduction in imports of— active pharmaceutical ingredients and other key starting materials that the Secretary determines are, or are likely to become, dependent upon such imports for a substantial portion of finished essential generic medicines; and finished dosage forms of essential generic medicines for which active pharmaceutical ingredients and other key starting materials are not imported; include provisions to strengthen domestic capacity for active pharmaceutical ingredient production, storage, and conversion; and outline plans and processes for coordinating and consulting, as appropriate, with the Assistant Secretary for Preparedness and Response regarding relevant issues of interest pertaining to the maintenance and stocking of the strategic national stockpile. The Plan shall include the following: Identification and prioritization of the essential generic medicines included on the most recent list under section 319N(a)— that the Secretary determines are essential for health care needs in the United States; and for which the Secretary determines that there is the greatest need to maintain a reserve of the active pharmaceutical ingredients and key starting materials for the essential generic medicines— taking into account factors including the extent to which the United States is, or is at risk of becoming, dependent on foreign sources for a substantial portion of the domestic need; and giving special consideration to the essential generic medicines at risk of supply interruption as a result of the factors described in section 319N(c)(4)(B). An evaluation of the utilization levels of the essential generic medicines identified under clause
(i)to inform how much of the active pharmaceutical ingredients of such medicines is required to cover the projected health care needs for one year of the United States population. A comprehensive assessment of the essential generic medicines identified under clause (i), including the existing manufacturing bases for each such medicine (including identification and location of ownership of such facilities) and whether the active pharmaceutical ingredients of such ingredients are manufactured domestically or abroad, and whether finished dosage conversion steps for such essential generic medicines are performed domestically or abroad. The types of facilities, equipment, and technology required to appropriately store, track, test, and convert all forms of active pharmaceutical ingredients that are critical inputs of drugs that are essential generic medicines, preliminary proposed locations for such public and privately owned facilities in multiple locations in the United States, the capacity required of the facilities used, and the estimated cost of acquisition and storage of the active pharmaceutical ingredients and management and operation of the facilities. An evaluation of the impact that the establishment and ongoing maintenance of the Reserve may have, including on availability and pricing of active pharmaceutical ingredients and finished drug dosages. A distribution plan for the active pharmaceutical ingredients held in the Reserve, which shall include— protocols for the method of conversion of active pharmaceutical ingredients into finished drugs, including conversion of key starting materials into active pharmaceutical ingredients and distribution from the Reserve into the strategic national stockpile and other government and commercial pharmaceutical distribution networks; and benchmarks for the Secretary to initiate conversion of drug products that are essential generic medicines using the active pharmaceutical ingredients stored in the Reserve for transfer to the strategic national stockpile or other government or commercial pharmaceutical distribution networks, based on changes in the supply chain for the top essential generic medicines or a determination by the Secretary regarding a threat to public health. A mechanism through which private sector manufacturers of active pharmaceutical ingredients or finished dosage forms may, through contracts with existing Reserve facilities, store and withdraw such ingredients in the Reserve to enhance resilience and reduce shortages and disruptions in the supply chain. A mechanism through which the Federal Government may purchase, via manufacturing partners, reserve capacity for finished drug manufacturing to convert active pharmaceutical ingredients into finished drugs for essential generic medicines. Pursuant to subparagraph (A)(i), the Secretary shall ensure that for the first year after the date of enactment of the Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines Act of 2021 , the Plan includes not less than 25 essential generic medicines, and that 25 additional essential generic medicines are included in such Plan for each year thereafter until the active pharmaceutical ingredients necessary to support the full list of essential generic medicines identified under section 319N(a) are covered. The Secretary shall prioritize essential generic medicines needed immediately in the event of an emergency. To the maximum extent practicable, the Plan should include a plan to ensure that, for each essential generic medicine included in the Plan, the active pharmaceutical ingredients used in the production of such medicine that are stored in the Reserve are available in the minimum quantities as follows: By the date that is 18 months after the date of enactment of the Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines Act of 2021 , not less than 10 percent of the total amount of such ingredients needed to produce sufficient quantities of the essential generic medicines for the treatment of individuals living in the United States. By the date that is 3 years after such date of enactment, not less than 25 percent of the total amount of such ingredients needed to produce sufficient quantities of the essential generic medicines for the treatment of individuals living in the United States. By the date that is 5 years after such date of enactment, not less than 50 percent of the total amount of such ingredients needed to produce sufficient quantities of the essential generic medicines for the treatment of individuals living in the United States. By the date that is 10 years after such date of enactment, not less than 90 percent of the total amount of such ingredients needed to produce sufficient quantities of the essential generic medicines for the treatment of individuals living in the United States. In calculating the quantities of active pharmaceutical ingredients needed for purposes of subparagraph (A), the Secretary shall determine the quantity of each essential generic medicine required to cover the projected health care needs, over a 1-year period, of people living in the United States, based on average annual demand during the 3-year period preceding the date of enactment of the Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines Act of 2021 . With respect to each active pharmaceutical ingredient and key starting material that is included in the Plan, the Secretary shall place in storage, transport, track, and exchange quantities of the substance that are— produced in conformance with all quality requirements under this Act and the Federal Food, Drug, and Cosmetic Act, including the associated regulations of such Acts; stored in compliance with— the requirements of parts 210 and 211 of title 21, Code of Federal Regulations, or any successor regulation; and any specific criteria agreed to by the Secretary and the manufacturer of the essential generic medicine using the active pharmaceutical ingredient or key starting material. To the greatest extent practicable, in carrying out paragraph (1), the Secretary shall acquire active pharmaceutical ingredients and key starting materials in a manner that minimizes cost, minimizes vulnerability of the United States to severe shortages or disruptions for essential generic medicines, minimizes the impact of acquisition of such ingredients and materials to the marketplace, gives preference to domestic manufacturers, and encourages competition in the marketplace. The Secretary may distribute active pharmaceutical ingredients and key starting materials in the Reserve in order to initiate conversion of active pharmaceutical ingredients and finished dosage form, in accordance with the Plan developed under subsection (b). In distributing active pharmaceutical ingredients and key starting materials under subparagraph (A), the Secretary, in consultation with the Commissioner of Food and Drugs and the Assistant Secretary for Preparedness and Response, may deviate from the Plan developed under subsection
(b)only after certifying that the distribution from the Reserve is required in response to a significant drug supply interruption. In carrying out this section, the Secretary shall consult with— the Commissioner of Food and Drugs, with respect to identifying essential generic medicines; the Administrator of the Centers for Medicare & Medicaid Services, with respect to determining the volume of essential generic medicines needed domestically; and the Assistant Secretary for Preparedness and Response, and, as appropriate, the Director of the Centers for Disease Control and Prevention, regarding coordination with the strategic national stockpile. The Commissioner of Food and Drugs shall provide to the Secretary the information collected under section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act, for purposes of carrying out this section. In carrying out this section, the Secretary shall— prioritize the purchase of active pharmaceutical ingredients and other key starting materials manufactured in the United States by domestic manufacturers to the maximum extent possible; contract with domestic entities for the— distribution of active pharmaceutical ingredients and finished drug products; storage, withdrawal, testing, and conversion of active pharmaceutical ingredients and other key starting materials; tracking and coordinating the storage, testing, and sale of active pharmaceutical ingredients and other key starting materials; sale of active pharmaceutical ingredients in advance of their expiration dates; and manufacturing, including continuous manufacturing as appropriate, of an active pharmaceutical ingredient or other key starting material of an essential generic medicine that is anticipated to be in shortage, as defined by the Secretary for purposes of this section; give preference to domestic nonprofit and public-private partnerships, as appropriate; ensure geographic diversity of the physical storage of active pharmaceutical ingredients and other key starting materials; support domestic manufacturers of active pharmaceuticals and other key starting materials and facilitate long-term domestic capacity for essential generic medicines in the United States; and prioritize contracts that facilitate the conversation of active pharmaceutical ingredients and other key starting materials into finished dosage form. Nothing in this subsection shall be construed to limit the Secretary's ability to enter into other types of contracts to facilitate the implementation of this section. The Secretary shall report to the applicable committees of Congress on supply chain resiliency with respect to active pharmaceutical ingredients for essential generic medicines, the status of the Reserve, and other relevant information in a manner that does not compromise national security. In this section: The term applicable committees of Congress means— the Committee on Health, Education, Labor, and Pensions and the Committee on Intelligence of the Senate; and the Committee on Energy and Commerce of the House of Representatives. The term essential generic medicine means a drug included on the most current list under section 319N(a). The term key starting material means an active pharmaceutical ingredient or critical input used in the manufacturing of an essential generic medicine, as well as ingredients or components that possess unique attributes essential in assessing the safety and effectiveness of such essential generic medicines, including excipients and inactive ingredients. There are authorized to be appropriated to carry out this section such sums as may be necessary. .
Connectionstraces to 1
Traces to 1 document
Citation graph
cites case law
Sec. 3
Establishment of the strategic active pharmaceutical ingredient reserve
Cites 1Cited by 0 across 0 sources