The US Food and Drug Administration (FDA) has joined forces with the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) to create the Tri-Agency Task Force for Emergency Diagnostics.
Per an FDA news release, the goal of the Task Force is to “leverage the expertise of each agency to advance rapid development and deployment of diagnostic tests in clinical and public health laboratories during public health emergencies.”
Jeffery Shuren, MD, JD, director of the FDA Center for Devices and Radiological Health noted that “[b]acteria and viruses don’t respect territorial boundaries,” adding that “[i]t takes a sustained, robust, and globally coordinated effort to protect our nation and the global community from various infectious disease threats.”
Separately, each agency plays a role in responding to public health emergencies. Through a the creation of a standardized collaborative effort, the Task Force will be able to address issues in the implementation of diagnostic tests under an Emergency Use Authorization process. The Task Force can also address “other unmet needs and gaps” in the preparation for and response to global health threats.
“While our globalized world and modern transportation help promote economic prosperity, these features also facilitate the spread of emerging infectious diseases,” said Chelsey Richards, the CDC Deputy Director for Public Health Science and Surveillance. “During public health emergencies, it is critical for diagnostic tests to be made available and adopted quickly into clinical and public health laboratories for rapid patient care.”
FDA, CDC, and CMS launch task force to help facilitate rapid availability of diagnostic tests during public health emergencies [news release]. Silver Spring, MD: US Food and Drug Administration. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632056.htm. February 26, 2019. Accessed February 27, 2019.