117th CONGRESS 1st Session |
To establish a strategic active pharmaceutical ingredient reserve to maintain a domestic supply of active pharmaceutical ingredients and key starting materials needed for the manufacturing of essential generic medicines, and to build a pipeline for domestic active pharmaceutical ingredient production.
Mr. Brown (for himself and Mr. Cassidy) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions
To establish a strategic active pharmaceutical ingredient reserve to maintain a domestic supply of active pharmaceutical ingredients and key starting materials needed for the manufacturing of essential generic medicines, and to build a pipeline for domestic active pharmaceutical ingredient production.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
This Act may be cited as the Promoting Readiness and Ensuring Proper Active pharmaceutical ingredient Reserves of Essential medicines Act of 2021 or the PREPARE Act .
SEC. 2. Listing of essential generic medicines.
Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 319M the following:
SEC. 319N. Listing of essential generic medicines.
(a) In general. The Secretary, in consultation with the Commissioner of Food and Drugs, the Assistant Secretary for Preparedness and Response, the Secretary of Defense, Secretary of Homeland Security, and other heads of agencies, as appropriate, shall establish and make public a list of essential generic medicines determined, in accordance with subsection (b), to be medically necessary to have available at all times.
(1) INITIAL LIST. The initial list of essential generic medicines under subsection (a) shall be the generic medicines included on the list of essential medicines, medical countermeasures, and critical inputs identified by the Commissioner of Food and Drugs as published on October 30, 2020, in accordance with section 3(c) of Executive Order 13944.
(1) ANNUAL REVIEW. Not less than once each year, the Secretary, after consultation with the Commissioner of Food and Drugs, the Assistant Secretary for Preparedness and Response, the Secretary of Defense, Secretary of Homeland Security, and other heads of agencies, as appropriate, shall review and update the list of essential generic medicines required under subsection (a).
(2) RATIONALE. In carrying out the annual review and update under paragraph (1), the Secretary shall provide a rationale for each essential generic medicine added to, or removed from, the list under subsection (a).
(3) SPECIFIC POPULATIONS. The Secretary shall consider including on the list under subsection (a), and, where appropriate, include on such list, essential generic medicines that are essential to specific subpopulations, including pediatric populations, in developing the list under such subsection.
(A) IN GENERAL. The Secretary, after consultation with the Public Health Emergency Medical Countermeasures Enterprise established under section 2811 1, shall conduct regular threat assessments, and take such assessments into consideration in updating the list in accordance with paragraph (1).
(B) THREAT ASSESSMENTS CONSIDERATIONS. Each threat assessment under this paragraph shall include consideration of
(i) the lack of existing domestic capacity of essential generic medicines;
(ii) the concentration of current supply of the essential generic medicine or active pharmaceutical ingredients of the essential generic medicine in one geographical region;
(iii) whether there are less than 2 manufacturers of the essential generic medicine or active pharmaceutical ingredients of the essential generic medicine; and
(iv) the potential for increased demand in a public health emergency.
(5) DIRECTOR OF THE STRATEGIC ACTIVE PHARMACEUTICAL INGREDIENTS RESERVE. The Secretary shall appoint a Director of the Strategic Active Pharmaceutical Ingredients Reserve who has experience in one or more of the following areas: supply chain management, disaster response, pharmaceutical or active pharmaceutical ingredient development, or logistics. Such Director shall ensure a sufficient supply of the active pharmaceutical ingredients and critical components necessary to manufacture the essential generic medicines included on the list under subsection (a) in an amount adequate to serve the needs of patients living in the United States and in the appropriate dosage forms.
(d) Appeal process. The Secretary shall establish a process by which stakeholders may appeal a determination by the Secretary not to include an essential generic medicine on the list under subsection (a).
(e) Definitions. In this section:
(1) DRUG. The term drug has the meaning given such term in section 201(g) of the Federal Food, Drug, and Cosmetic Act, and includes a biological product (as defined in section 351(i) of this Act). Such term includes prescription and nonprescription drugs, or active pharmaceutical ingredients of drugs.
(2) ESSENTIAL GENERIC MEDICINE. The term essential generic medicine means a drug for which a generic is approved, that is medically necessary to have available at all times because the drug is
(A) commonly used to prevent, mitigate, or treat a common disease or condition, or used in a common procedure;
(B) an antibiotic or antifungal used to treat an infectious diseases;
(C) necessary to prevent or mitigate a public health emergency; or
(D) life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition. .
SEC. 3. Establishment of the strategic active pharmaceutical ingredient reserve.
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:
SEC. 319N 1. Strategic active pharmaceutical ingredient reserve.
(a) Strategic Active Pharmaceutical Ingredient Reserve Plan.
(1) IN GENERAL. 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).
(2) ANNUAL UPDATES. 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.
(3) NATIONAL SECURITY CONSIDERATIONS.
(A) SUBMISSIONS. 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.
(B) EXEMPTION FROM DISCLOSURE. 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.
(1) IN GENERAL. The Plan required under subsection (a) shall
(A) 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 );
(B) detail the requirements for maintaining the Reserve described in subsection (c), including
(i) storage and testing requirements, consistent with parts 210 and 211 of title 21, Code of Federal Regulations, or any successor regulation; and
(ii) 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;
(C) be designed to minimize the impact of any interruption or reduction in imports of
(i) 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
(ii) finished dosage forms of essential generic medicines for which active pharmaceutical ingredients and other key starting materials are not imported;
(D) include provisions to strengthen domestic capacity for active pharmaceutical ingredient production, storage, and conversion; and
(E) 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.
(A) IN GENERAL. The Plan shall include the following:
(i) Identification and prioritization of the essential generic medicines included on the most recent list under section 319N(a)
(I) that the Secretary determines are essential for health care needs in the United States; and
(II) 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
(aa) 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
(bb) 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).
(ii) 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.
(iii) 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.
(iv) 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 a