Emergency Use Authorization

Medical Community Leaders Roundtable

November 12, 2021

1-4 pm ET

Agenda

Moderator: Susan C. Winckler, RPh, Esq., CEO, Reagan-Udall Foundation for the FDA

Goals of Roundtable:

• Discuss the medical communities’ experience with FDA Emergency Use Authorizations (EUAs) and FDA’s use of emergency use authorities during the COVID-19 pandemic.
• Understand how FDA can most effectively share information with the medical community about a product under an EUA and its authorized use(s).
• Explore under what circumstances benefit-risk assessments may vary (both in FDA’s determination and the medical community’s use of the products) and how those assessments might vary with different EUA products (e.g., therapeutics, diagnostic tests, and vaccine).
• Discuss the intersection of medical product availability both under an EUA and through the conduct of clinical trials. 

 

1 pm ET              Welcome
Susan C. Winckler, RPh, Esq., CEO, Reagan-Udall Foundation for the FDA

1:05 pm              Opening Remarks

Jacqueline A. O'Shaughnessy, PhD, Acting Chief Scientist, Office of the Chief Scientist, U.S. Food and Drug Administration 

1:10 pm              Background

Elizabeth Sadove, JD, Director of Medical Countermeasures Regulatory Policy, Office of Counterterrorism and Emerging Threats, Office of Chief Scientist, Office of the Commissioner, U.S. Food & Drug Administration

 

1: 20 pm             Introductions (~5 minutes per participant)

                           What is one aspect of FDA’s COVID-19 EUA activities that you would want to applaud/highlight? What is one
                           aspect/component that you would want to tweak or change?

 

2 pm                    Key Themes from Healthcare Practitioner Roundtable

                             Discuss key themes raised during healthcare practitioner roundtable

2:05 pm              Participant Discussion: Information Regarding Use of EUA Products  

                           What information disseminated with EUAs (e.g., fact sheets, Q/A documents, Dear health care provider letters, review/decision memos)
                           has been useful to the medical community? What other information would you want to see?

 

2:45 pm              Participant Discussion: Benefit-Risk Assessment

• Risk/benefit assessments to support authorization vary with the product type (e.g., therapeutics, diagnostic tests, and vaccine) and with different circumstances (e.g., as the PHE evolves). How does this flexibility, which has proved helpful during the COVID-19 response, impact perceptions about products authorized under an EUA?  
• How can additional information (e.g., from real world evidence) be made available or processes established to help inform continued product development and to continue to inform FDA’s benefit-risk assessments for medical products authorized for emergency use? What are the barriers (e.g. data sharing) to the goal of evidence generation during the response?

 

3:30 pm              Participant Discussion: Data Generation and Medical Community Input

                            What are the opportunities presented for information dissemination, transparency, and data general, risk/benefit assessment?

 

3:55 pm              Summary

 

4 pm                    Adjourn