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Innovation Law and COVID-19

Document Type

Book Section

Publication Date

2023

Publication Title

COVID-19 and the Law

Abstract

This chapter considers how innovation policy and health law – including food and drug regulation, healthcare reimbursement, and direct R&D subsidies – have both encouraged and impeded the development and allocation of new technologies in the fight against COVID-19. First, an expansive diagnostic testing program for COVID-19 is critical both to slow the spread of the disease and to ensure that future outbreaks can be detected early. The disastrous US testing response represents both an individual regulatory failure and a failure of coordination among agencies including the Food and Drug Administration (FDA), Centers for Disease Control (CDC), and Centers for Medicare and Medicaid Services (CMS). On the treatment side, drugmakers have rushed to identify new and existing compounds for potential COVID-19 efficacy against the backdrop of potentially lengthy and expensive clinical trials. In response, the FDA has granted Emergency Use Authorizations for several of these drugs, which requires balancing risks and harms on only minimal evidence. The intersection between incentives and regulatory oversight has profoundly shaped the innovation landscape for new COVID-19 treatments, such as by permitting widespread use in ways that do not improve the evidence base about which therapeutics are most effective. Finally, extinguishing COVID-19 will require the development of a broadly effective vaccine. This is an opportunity to develop and implement novel ex post rewards, including reimbursement incentives per vaccination to promote vaccine uptake. Each of these areas reveals important lessons to help policymakers better prepare for the next pandemic.

Keywords

Federal Drug Administration, COVID-19, Innovation Policy, Public Health, Intellectual Property Law, R&D, Grants, Procurement, NIH, FDA, EUA, CMS, Vaccines, Diagnostics, Antibody Testing, Remdesivir, Therapeutic Antibodies, Convalescent Serum Therapy, Pharmaceutical Manufacturing, Clinical Trials, N95s, 3d Printing, AI

Publication Citation

Rachel Sachs Lisa Larrimore Ouellette, W. Nicholson Price II, Jacob S. Sherkow, Innovation Law and COVID-19: Promoting Incentives and Access for New Health Care Technologies, in COVID-19 and the Law: Disruption, Impact and Legacy 225-236 ( I. Glenn Cohen, Abbe R. Gluck, Katherine Kraschel & Carmel Shachar eds., 2023)

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