Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Diseases?. Issue 12 (2nd December 2021)

• Record Type: Journal Article
• Authors: Lynch, Holly Fernandez; Caplan, Arthur; Furlong, Patricia; Bateman-House, Alison
• Is Part Of: American journal of bioethics. Volume 21:Issue 12(2021)
• Page Start: 4
• Page End: 19
• Publication Date: 2021-12-02
• Subjects: COVID-19 -- pandemic response -- Operation Warp Speed -- emergency use authorization -- clinical research -- expanded access; Bioethics -- Periodicals; Medical ethics -- Periodicals; 174.957
• DOI: 10.1080/15265161.2021.1974975
• Languages: English
• ISSNs: 1526-5161

Abstract

Abstract: After witnessing extraordinary scientific and regulatory efforts to speed development of and access to new COVID-19 interventions, patients facing other serious diseases have begun to ask "where's our Operation Warp Speed?" and "why isn't Emergency Use Authorization an option for our health crises?" Although this pandemic bears a number of unique features, the response to COVID-19 offers translatable lessons, in both its successes and failures, for non-pandemic diseases. These include the importance of collaborating across sectors, supporting the highest-priority research efforts, adopting rigorous and innovative trial designs, and sharing reliable information quickly. In addition, the regulatory response to the pandemic demonstrates that lowering standards for marketing authorization can result in increased safety concerns, missed opportunities for research and treatment, and delays in determining what works. Accordingly, policymakers and patient advocates seeking to build on the COVID-19 experience for non-pandemic diseases with unmet treatment needs should focus their efforts on promoting robust and efficient research designs, improving access to clinical trials, and facilitating use of the Food and Drug Administration's existing Expanded Access pathway.