Emergency Preparedness and Response
State, Tribal, Local, and Territorial Public Health Preparedness
Photo courtesy of Baltimore City Health Department
FDA has many medical countermeasure (MCM) roles. MCMs include drugs, vaccines, diagnostic tests, and other medical products used in public health emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions resulting from chemical, biological, radiological, and nuclear (CBRN) threats. This includes emerging infectious diseases, such as pandemic influenza.
Among FDA’s MCM roles, FDA works closely with stakeholders at the state and local levels to support public health preparedness and response efforts related to MCMs. Stakeholders’ MCM preparedness and response efforts include activities such as stockpiling, distributing, and dispensing or administering MCMs (e.g., antibiotics) during or in anticipation of a public health emergency (e.g., an anthrax attack or influenza pandemic).
Through certain legal mechanisms, FDA can help make available safe and effective MCMs for use in emergencies by state and local partners. One of these tools is an Emergency Use Authorization (EUA) under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Through an EUA, in certain situations FDA may authorize the use of an unapproved medical product—or an unapproved use of an approved medical product—to counter CBRN and emerging infectious disease threats.
In March 2013, the President signed into law the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA). Among other things, this law amended the EUA authority. It also created new FDA authorities related to the emergency use of MCMs. These changes resulting from PAHPRA will further facilitate state and local preparedness for emergencies that involve the use of MCMs.
Meetings and Presentations
The following recent presentations, given by the Office of Counterterrorism and Emerging Threats, discuss MCM legal preparedness and response issues, including EUAs.
- March 2013: FDA’s Roles in Preparedness and Planning.Video interview from Public Health Preparedness Summit 2013: Strengthening Public Health and Healthcare Preparedness through Innovation, Integration, and Implementation.
- October 2012: FDA Legal Preparedness Tools for Distributing and Dispensing Medical Countermeasures (PDF - 777KB)
- March 2012: Recent Developments in FDA's Emergency Authority for Medical Countermeasures
- March 2012: Recent Developments in FDA's Emergency Authority for Medical Countermeasures Question and Answer document
- February 2012: FDA's Role in Medical Countermeasures - Current Issues and Challenges (PDF - 582KB)
- February 2012: FDA MCMI Anthrax Preparedness Presentation/ FDA Response Planning and Execution (PDF - 836KB)
- December 2010: Federal, State, and Local Public Health Preparedness Legal and Regulatory Meeting
- December 2010: Q's and A's on Public Health Preparedness Meeting
Question and Answer Documents
The statutory authority discussed in the following question and answer documents has been amended by PAHPRA, which was enacted in March 2013.
Questions and Answers: Recent Developments in FDA's Emergency Authority for Medical Countermeasures Interim Questions and Answers: Emergency Use Authorization for Oral Formulations of Doxycycline for Post-Exposure Prophylaxis of Inhalational Anthrax Q's and A's on Public Health Preparedness Meeting Emergency Use Authorizations Questions and Answers
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;41(s1):22-27.
- 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.
- Courtney B, Sadove E. Medical Countermeasures: Emergency Preparedness and Response Roles and Authorities, in FOOD AND DRUG LAW AND REGULATION (2d ed. 2012) (David G. Adams, Richard M. Cooper, Martin J. Hahn, Jonathan S. Kahan, eds.).