Sec. 30516. Recommendations to encourage domestic manufacturing of critical drugs
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Not later than 14 days after the date of enactment of this Act, the Secretary shall enter into an agreement with the National Academies of Sciences, Engineering, and Medicine (referred to in this section as the National Academies ) under which, not later than 90 days after the date of entering into the agreement, the National Academies will— establish a committee of experts who are knowledgeable about drug and device supply issues, including— sourcing and production of critical drugs and devices; sourcing and production of active pharmaceutical ingredients in critical drugs; the raw materials and other components for critical drugs and devices; and the public health and national security implications of the current supply chain for critical drugs and devices; convene a public symposium to— analyze the impact of United States dependence on the foreign manufacturing of critical drugs and devices on patient access and care, including in hospitals and intensive care units; and recommend strategies to end United States dependence on foreign manufacturing to ensure the United States has a diverse and vital supply chain for critical drugs and devices to protect the Nation from natural or hostile occurrences; and submit a report on the symposium’s proceedings to the Congress and publish a summary of such proceedings on the public website of the National Academies.
In carrying out the agreement under subsection (a), the National Academies shall consult with— the Department of Health and Human Services, the Department of Homeland Security, the Department of Defense, the Department of Commerce, the Department of State, the Department of Veterans Affairs, the Department of Justice, and any other Federal agencies as appropriate; and relevant stakeholders, including drug and device manufacturers, health care providers, medical professional societies, State-based societies, public health experts, State and local public health departments, State medical boards, patient groups, health care distributors, wholesalers and group purchasing organizations, pharmacists, and other entities with experience in health care and public health, as appropriate.
For the purposes of this section: The term critical — with respect to a device, refers to a device classified by the Food and Drug Administration as implantable, life-saving, and life-sustaining; or with respect to a drug, refers to a drug that is described in subsection
(a)of section 506C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c ) (relating to notification of any discontinuance or interruption in the production of life-saving drugs). The terms device and drug have the meanings given to those terms in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ).
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Sec. 30516
Recommendations to encourage domestic manufacturing of critical drugs
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