FDA updates on medical countermeasure-related public health preparedness, response

June 1, 2021

The U.S. Food and Drug Administration (FDA) released its annual FY 2020 MCMi Program Update on  medical countermeasures (MCMs)—including drugs, vaccines and diagnostic tests—which are safe, effective, and secure against infectious diseases.

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 2020 report includes a snapshot of the Agency's COVID-19 response efforts through Sep. 30, 2020. FDA’s overarching objective with respect to MCMs— which cuts across all FDA centers and offices engaged in the MCM mission space—is to facilitate the timely development of and access to safe and effective MCMs to counter CBRN and emerging infectious disease threats for civilian populations, as well as MCMs to support American military personnel.

Report highlights include:

·        Facilitating development of MCMs to diagnose, prevent, or treat COVID-19, including by working with medical product sponsors to clarify regulatory and data requirements necessary to rapidly advance development of products essential to supporting response efforts.

·         Enabling access to investigational MCMs and accurate and reliable tests through an appropriate mechanism, such as Emergency Use Authorization (EUA) or Investigational New Drug (IND).8 FDA issued 287 EUAs enabling the use of more than 575 medical products to support the COVID-19 response in FY 2020.

·         Actively monitoring the medical product and food supply chains to address imbalances. FDA continues to screen and monitor millions of domestic and international products in the medical supply chain to help ensure COVID-19-related supplies coming into the U.S. are safe and distributed appropriately

·         Protecting the safety of the nation’s blood supply and human cells, tissues, and cellular/ tissue-based products for transplantation (HCT/Ps). Issued three guidance documents to support the urgent need for blood during the pandemic while still protecting the nation’s blood supply.

·         Protecting consumers against fraudulent products. Unfortunately, during emergency situations, fraudulent products claiming to prevent, treat or cure conditions associated with the emergency almost always appear for sale. The FDA monitors for fraudulent products and false product claims related to MCMi Program Update FY 2020 7 COVID-19 and other conditions and takes appropriate action to protect patients and consumers.

·         Conducting and collaborating on regulatory science research to help ensure FDA’s ability to quickly assess safety and efficacy of new Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) MCMs, and to help diagnostic test developers validate and ensure the quality and performance of their tests

·         Engaging with partners on innovative approaches to respond to COVID-19 as quickly and safely as possible.

·      Proactive COVID-19 communication FDA has been as transparent as possible about our COVID-19 response activities, communicating early and often with stakeholders and the American public.

FDA has the report.

FDA has the release.

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