FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad

By Stephen M. Hahn, M.D, FDA Commissioner

SILVER SPRING, Md., Feb. 14, 2020  — The FDA plays an essential role in overseeing our Nation’s medical products as part of our vital mission to protect and promote public health, including during public health emergencies. The FDA is an active partner in the Novel Coronavirus (COVID-19) response, working closely with our government and public health partners across the U.S. Department of Health and Human Services, as well as with our international counterparts. Our work is multifaceted, focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools as we oversee the safety and quality of FDA-regulated products for American patients and consumers.

Active Supply Chain Surveillance
We are keenly aware that the outbreak will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S. We are not waiting for drug and device manufacturers to report shortages to us—we are proactively reaching out to manufacturers as part of our vigilant and forward-leaning approach to identifying potential disruptions or shortages. The FDA has dedicated additional resources to review and coordinate data to better identify any potential vulnerabilities to the U.S. medical product sector, specifically from this outbreak.

We have been in contact with hundreds of manufacturers of human and animal drugs and medical devices, as well as syncing up with global regulators, like the European Medicines Agency, to assess and monitor for indications and early warning signs of potential manufacturing discontinuances or interruptions due to the outbreak. It’s worth noting that there are no vaccines, gene therapies, or blood derivatives licensed by the FDA that are manufactured in China. Raw materials used in manufacturing do come from China and other locations in Southeast Asia and we are in contact with biologics manufacturers to gauge any supply concerns regarding raw materials.

This remains an evolving and very dynamic situation with respect to potential shortages. We are tracking reports of increased ordering of some essential medical devices through distributors, such as personal protective equipment (PPE) (e.g. respirators and surgical gowns, gloves and masks).

If a potential shortage or disruption of medical products is identified by the FDA, we will use all available tools to react swiftly and mitigate the impact to U.S. patients and health care professionals. These tools include closely working with manufacturers and expediting review of alternate supply to prevent shortages, among other measures, with the common goal of minimizing any negative impact to public health in America. Continue reading

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Understory Launches Hail Insurance for Automotive Dealers in Five New States

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