MCM-Related Legal and Policy Presentations, Publications and Q&As

FDA continues to ensure that U.S. laws, regulations, and policies enable the application of advances in regulatory science to the regulatory review process for medical countermeasures (MCMs).

We also support preparedness for and response to chemical, biological, radiological, nuclear (CBRN), and emerging infectious disease threats by facilitating the availability of MCMs and working with state and local authorities to support preparedness and response capabilities at the state and community levels.

The resources below provide updates on FDA activities to support the MCM-related legal and policy framework, to better protect national health and security. The following documents and presentations discuss MCM legal preparedness and response issues, including Emergency Use Authorizations.

Meetings and Presentations

• Medical Products Post-Public Health Emergency: Emergency Use Authorizations and the Transition to a New Normal (PDF, 480 KB)
  May 2023: Elizabeth Sadove and Jean McCue present at the Food and Drug Law Institute Annual Conference
• FDA’s EUAs and Other Related Authorities (PDF, 940 KB)
  November 2021: Regulatory counsel, Elizabeth Sadove presents at BARDA Industry Day 
• FDA’s EUAs and Other Related Authorities (PDF, 158 KB)
  May 2021: Regulatory counsel, Jennifer Ross presents at the 2021 PMDA Spring Symposium
• Overview from FDA - Tri-Agency Task Force for Emergency Diagnostics Session (PDF, 692 KB)
  April 2021: Regulatory counsel, Jennifer Ross presents at the 2021 Preparedness Summit
• Overview of FDA’s Emergency Use Authorization (EUA) Authority & COVID-19 Response (PDF, 438 KB)
  March 2021: Regulatory Counsel, Brooke Courtney presents at the American Bar Association Health Law Section
• Overview of FDA’s Emergency Use Authorization (EUA) Authority (PDF, 403.36 KB)
  March 2021: Regulatory Counsel, Brooke Courtney presents at the CSTE Public Health Law Webinar: Implications for COVID-19 Vaccination
• Emergency Response Authorities and Access to Medical Countermeasures (PDF, 654.36 KB)
  February 2021: Regulatory Counsel, Brooke Courtney presents at the PHEP Connects Webinar 

Archived meetings and presentations (2020 and older)

• Emergency Response Authorities and Access to Medical Countermeasures FDA-CDC Joint Learning Session: Regulatory Updates on Use of Medical Countermeasures (PDF, 862.91 KB) [ARCHIVED]
  August 2020: Regulatory Counsel, Elizabeth Sadove presents at the Preparedness Summit  
• Beyond the Last Mile: Monitoring and Assessing Medical Countermeasure Use in Response to Public Health Emergencies (PDF, 1.6 MB) [ARCHIVED]
  May 2018: Regulatory Counsel, Greg Measer presents at the NASEM Biosecurity luncheon
• Emergency Use of Medical Countermeasures: FDA Roles and Authorities (PDF, 1.8 MB) [ARCHIVED]
  February 2018: FDA OCET presentation as part of the University of Arizona Regulatory Science Series
• FDA Roles in Supporting the Emergency Use of Medical Countermeasures (PDF, 495 KB) [ARCHIVED]
  January 2018: Presented at the National Interagency Confederation for Biological Research – Scientific Interaction Subcommittee (NICBR-SIS) Winter Forum
• Extending Expiration Dates of Stockpiled Doxycycline for Anthrax Preparedness
  September 2017: CDC and FDA hosted a webinar to discuss FDA’s draft guidance Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. A recording, slides and Q and A are available in CDC TRAIN (free account required).
• Beyond the Last Mile: Monitoring and Assessing Medical Countermeasure Use in Response to Public Health Emergencies (PDF, 1.5 MB) [ARCHIVED]
  April 2017: FDA OCET presentation at the Preparedness Summit
• Emergency Legal Preparedness Summit (YouTube) April 2017: Video recording of a panel of public health preparedness experts, including FDA, examining critical challenges in emergency legal preparedness and policy at Georgetown University Law Center (2 hours, 16 minutes)
• Emergency Legal Preparedness and FDA Response to Zika Virus (PDF, 1.4 MB) [ARCHIVED]
  December 2016: FDA OCET presentation at the American Bar Association Washington Health Summit
• FDA's Medical Countermeasure Role in Preparedness and Response (PDF, 549 KB) [ARCHIVED]
  September 2016: FDA OCET presentation at the National Biosurveillance Integration Center Interagency Biosurveillance Presentation Series and Information-Sharing Forum
• ZIKA VIRUS and Emergency Legal Preparedness: FDA Zika Response Efforts (PDF, 152 KB) [ARCHIVED]
  September 2016: FDA OCET presentation at the National Public Health Law Conference Washington, DC
• Expedited Development Programs and Emergency Access Mechanisms (PDF, 130 KB) [ARCHIVED]
  April 2016: FDA OCET presentation UTMB-FDA Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories
• Federal Updates on the Emergency Use of MCMs: EUAs, EUIs, and Beyond (PDF, 655 KB) [ARCHIVED]
  April 2015: FDA OCET presentations at the Preparedness Summit
• PAHPA Reauthorization and Federal Legal Preparedness Updates (PDF, 318 KB) [ARCHIVED]
  October 2014: FDA OCET presentations at the Public Health Law Conference
• MCM Policy Updates Following the 2013 Enactment of PAHPRA (PDF, 344 KB) [ARCHIVED]
  June 2014: Presentation from the 12th Annual Emerging Infectious Diseases Biodefense conference
• FDA Legal Preparedness Tools for Distributing and Dispensing Medical Countermeasures (PDF - 777 KB) [ARCHIVED]
  October 12, 2012: 2012 Public Health Law Conference (prior to PAHPRA)
• Federal, State, and Local Public Health Preparedness Legal and Regulatory Meeting [ARCHIVED]
  December 14-15, 2010 (prior to PAHPRA)

Publications

• Public Health Emergencies: Unpacking Medical Countermeasures Management for Preparedness and Response
  Measer GT, Maher CT, Hu-Primmer J. Am J Public Health. 2018 Sep;108(S3):S224-S226.
• Medical Countermeasures: Emergency Preparedness and Response Roles and Authorities (book chapter)
  Courtney B, Sadove E. Medical Countermeasures: Emergency Preparedness and Response Roles and Authorities, in FOOD AND DRUG LAW AND REGULATION (3rd ed. 2015) (David G. Adams, Richard M. Cooper, Martin J. Hahn, Jonathan S. Kahan, eds.).
• Regulatory Underpinnings of Global Health Security: FDA's Roles in Preventing, Detecting, and Responding to Global Health Threats (open access article)
  Courtney B, Bond K., Maher C. Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science. September/October 2014, 12(5): 239-246. doi:10.1089/bsp.2014.0046.
• Federal legal preparedness tools for facilitating medical countermeasures use during public health emergencies
  Courtney B, Sherman S, Penn M. Federal legal preparedness tools for facilitating medical countermeasures use during public health emergencies. Journal of Law, Medicine, & Ethics. 2013 Mar;41 Suppl 1:22-7. doi: 10.1111/jlme.12033.
• Meeting the challenges of medical countermeasure development (open access article)
  Maher C, Hu-Primmer J, MacGill T, Courtney B, Borio L. Meeting the challenges of medical countermeasure development. Microbial Biotechnology 2012;5(5):588-593.

Question and Answer Documents

• FAQs: What happens to EUAs when a public health emergency ends? (April 2022)
• Vaccine EUA Questions and Answers for Stakeholders (December 2020)
• PAHPRA Q and A for Public Health Preparedness and Response Stakeholders (PDF, 250 KB) [ARCHIVED]

Related Links

 

• MCMi Publications and Reports
• MCMi News and Events
• Pediatric Medical Countermeasures
• MCMi Collaborations