FDA plays a critical role in protecting the United States from chemical, biological, radiological, nuclear, and emerging infectious disease threats. FDA ensures that medical countermeasures (MCMs)—including drugs, vaccines and diagnostic tests—to counter these threats are safe, effective, and secure.
FDA works closely with interagency partners through the U.S. Department of Health and Human Services (HHS) Public Health Emergency Medical Countermeasures Enterprise (PHEMCE, or Enterprise) to build and sustain the MCM programs necessary to effectively respond to public health emergencies. FDA also works closely with the U.S. Department of Defense (DoD) to facilitate the development and availability of MCMs to support the unique needs of American military personnel.
The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), requires FDA to issue an annual report detailing its medical countermeasure activities. This report responds to that requirement for the latest fiscal year available.
The FY 2021 report includes a snapshot of the Agency's COVID-19 response efforts through September 30, 2021, and a new infographic about FDA's COVID-19 response from the beginning of the COVID-19 public health emergency through the end of FY 2021 (September 30, 2021).
For current updates from MCMi, including updates after the reporting period, subscribe to our newsletter by entering your email in the box below, or visit our news and events page.
For previous reports, please see Publications and Reports.
FDA Voices on Policy: FDA Protecting the Nation Through Medical Countermeasures (April 9, 2019)