Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Diseases?

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.

Automated summary

The response to the COVID-19 pandemic has provided valuable lessons for addressing non-pandemic diseases, emphasizing the importance of collaboration, supporting critical research, innovative trial designs, and rapid information sharing. However, lowering regulatory standards may lead to safety concerns, missed research opportunities, and delays in determining effective treatments. Policymakers and patient advocates should focus on promoting robust research designs, improving access to clinical trials, and facilitating use of existing pathways for unmet treatment needs in non-pandemic diseases.