COVID-19 Emergency Manufacturing Act Summary
Senator Elizabeth Warren (D-Mass.) and Representative Jan Schakowsky (D-Ill.)
Medical tools and therapeutics urgently needed to diagnose, treat, mitigate and prevent COVID-19 should be accessible and available to all without delay. But health care providers throughout the country have already faced shortages of personal protective equipment like N95 masks, medical devices like ventilators, and prescriptions drugs for patients on ventilators. Drug corporations’ estimates show that if and when COVID-19 treatment and vaccine candidates are shown to be safe and effective, they still will not have sufficient production capacity to rapidly meet unprecedented global need.[1] Public manufacturing could help ensure adequate supply and avoid rationing.
The COVID-19 Emergency Manufacturing Act:
- Establishes an Emergency Office of Manufacturing for Public Health within the Department of Health and Human Services.
- Requires the Office to begin public manufacturing of:
- Diagnostic materials for COVID-19 within one month of the date of enactment of the Act;
- Personal protective equipment used to protect against coronavirus transmission within one month of the date of enactment of the Act; and
- Drugs (including active pharmaceutical ingredients) in shortage necessary for the treatment of severe COVID-19 cases as soon as practicable;
- Authorizes the Office to manufacture or enter into contracts with other entities to manufacture:
- Drugs, biological products, medical devices, and personal protective equipment used to help diagnose, mitigate, prevent, treat or cure COVID-19 or limit the harm of COVID-19; and
- Drugs, biological products and medical devices in shortage.
- Requires the Office to prioritize manufacturing of products, drugs, biologics and devices that have the greatest impact on the COVID-19 response, addressing shortages, reducing public health program costs, and alleviating demographic disparities in COVID-19 outcomes.
- Requires the Office to construct manufacturing facilities for a range of vaccine platform technologies and therapeutics after clinical data demonstrates strong positive indications of safety and efficacy.
- Authorizes the Office to issue and publicly disclose licenses, as useful for performing its duties under the Act, in exchange for reasonable royalties, allowing the Office to practice or have practiced patented inventions, including referencing or relying upon regulatory test data, and accessing and using otherwise confidential information relating to the manufacturing of COVID-19 products, including know-how.
- Requires the Office to provide drugs, biological products, medical devices, and personal protective equipment used to help diagnose, mitigate, prevent, treat or cure COVID-19 or limit the harm of COVID-19 at no cost to domestic health programs and health care providers, and to sell them at cost to other commercial entities and international entities.
- Requires the Office to sell drugs, biological products and medical devices produced by the Office in response to a shortage at a fair price.
- Requires the Inspector General of the Department of Health and Human Services to review no fewer than one out of three contracts entered into the by the Office under the Act and for the Director of the Office to submit regular monthly reports to Congress with respect to the activities of the Office.
The COVID-19 Emergency Manufacturing Act has been endorsed by Public Citizen, Center for American Progress, Social Security Works, Indivisible, Center for Medicare Advocacy, American Federation of Teachers, Knowledge Ecology International, Action Center on Race and the Economy, MomsRising, Families USA, People’s Action, Voices for Progress, Treatment Action Group, Consumer Action, UNITE HERE!, Progressive Democrats of America, National Women’s Health Network, Coalition on Human Needs, Labor Campaign for Single Payer, Health Care for America Now, PrEP4All, NETWORK Lobby for Catholic Social Justice, Lower Drug Prices Now, Universities Allied for Essential Medicines, National Adult Day Services Association, National Association of Social Workers, National Association for Home Care and Hospice, National Consumer Voice for Quality Long-Term Care, American Medical Students Association, Democracy Collaborative, Main Street Alliance Action Fund, Center for Popular Democracy Action, Faith in Healthcare, Oxfam America, Doctors for America, and the National Committee to Preserve Social Security and Medicare.
[1] Johnson & Johnson aims to produce 600 to 900 million doses of its vaccine candidate by April 2021 if human trials go well. Sanofi hopes to produce up to 600 million doses of its vaccine candidate next year if clinical trials with GlaxoSmithKline go well. Moderna hopes to produce millions of doses per month in 2020 and tens of millions per month in 2021. Gilead states this its goal is to produce “several million” treatment courses of remdesivir in 2021, if required.