FDA Provides Update on Activities Related to Coronavirus

Says it continues to monitor the global drug supply chain by prioritizing risk-based inspections in other parts of the world

The FDA has provided an update on FDA-wide activities related to the novel coronavirus outbreak: COVID-19. The FDA is working on a multi-pronged approach to this public health emergency, including 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, including enforcement tools to stop fraudulent activity as we oversee the safety and quality of FDA-regulated products for American patients and consumers.

FDA inspections in China and the agency’s oversight of imported products from China, have been impacted by this outbreak. While the FDA is not able to conduct inspections in China right now, the agency says it is not hindering efforts to monitor medical products and food safety. The FDA says it continues to monitor the global drug supply chain by prioritizing risk-based inspections in other parts of the world. The FDA is not currently conducting inspections in China in response to the U.S. Department of State’s Travel Advisory to not travel to China due to the novel coronavirus outbreak. When the travel advisory is changed, the agency will resume routine inspections as soon as feasible.

The FDA already uses other tools to help complement inspections, including import screening, examinations, sampling, and import alerts, relying on a firm’s previous compliance history, and we use information from foreign governments as part of mutual recognition agreements. According to the FDA, these other tools are reliable to give comprehensive oversight of FDA-regulated products entering this country. This is all part of our agency’s risk-based approach to ensuring quality, as well as compliance, with applicable FDA requirements.

A wide variety of FDA-regulated products are imported from China, which makes it important to assure the public of the quality of these products. At this time, over 60% of FDA-regulated products imported from China are medical devices and 20% are housewares (like food packaging).