FDA’s Role in the Medical Product Supply Chain and Considerations During COVID-19

"The Coronavirus Disease 2019 (COVID-19) pandemic has affected the medical product supply chain globally and domestically. Although concerns about the U.S. medical product supply chain predate the emergence of COVID-19, the ongoing pandemic has underscored the importance of understanding the supply chain—in particular, U.S. reliance on foreign sources of medical products and the federal government’s ability to oversee the supply chain and mitigate future disruptions.

The Food and Drug Administration (FDA), within the Department of Health and Human Services (HHS), is the federal agency responsible for ensuring the safety and effectiveness of medical products—drugs and medical devices—marketed in the United States. The FDA therefore plays a critical role in overseeing aspects of the U.S. medical product supply chain. Drug and medical device (“device”) manufacturers are subject to FDA-mandated reporting requirements related to the supply chain. For example, establishments that manufacture drugs and devices are required to register with FDA and must report various manufacturing-related information to the agency. These requirements apply to both domestic and foreign establishments that import drugs and devices into the United States. However, concerns have been raised that certain manufacturers, such as those producing medical products or components that are not imported directly into the United States, may not be registered with FDA. This potential blind spot may limit the agency’s ability to oversee the medical product supply chain and monitor the entities manufacturing such products for the U.S. market.

In response to concerns about FDA regulation of drugs and devices in the global supply chain, Congress has introduced and passed legislation to help regulators, stakeholders, and the public better understand the medical product supply chain both during and beyond public health emergencies. The recently enacted Coronavirus Aid, Relief, and Economic Security Act (CARES Act; P.L. 116-136), for example, expanded drug listing and reporting requirements to help quantify for regulators the volume of finished drug products and active pharmaceutical ingredients (APIs) manufactured domestically and abroad for the U.S. market. The CARES Act also provided FDA the explicit authority to require certain device manufacturers to report interruptions or discontinuances in manufacturing during public health emergencies. More broadly, the CARES Act requires the National Academies of Science, Engineering, and Medicine (NASEM) to examine and report on the security of the U.S. medical product supply chain, including U.S. dependence on critical drugs and devices from other countries..."
FDA and medical supply chain