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.