Sec. 2. Listing of essential generic medicines
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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: 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. 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. 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). 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). 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. 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). Each threat assessment under this paragraph shall include consideration of— the lack of existing domestic capacity of essential generic medicines; the concentration of current supply of the essential generic medicine or active pharmaceutical ingredients of the essential generic medicine in one geographical region; whether there are less than 2 manufacturers of the essential generic medicine or active pharmaceutical ingredients of the essential generic medicine; and the potential for increased demand in a public health emergency. 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. 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). In this section: 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. 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— commonly used to prevent, mitigate, or treat a common disease or condition, or used in a common procedure; an antibiotic or antifungal used to treat an infectious diseases; necessary to prevent or mitigate a public health emergency; or life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition. .
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