- The Food and Drug Administration on Friday outlined its efforts to track potential supply chain disruptions emanating from the spread of the new coronavirus from China, noting increased ordering of surgical masks, gowns and other personal protective equipment through distributors.
- Agency chief Stephen Hahn said in a statement that shifting ordering patterns has yet to result in shortages but warned the situation is "evolving and very dynamic."
- The agency is holding off on conducting medical product inspections in China, heeding the State Department's warning against traveling to the country where the outbreak began. Still, Hahn noted the FDA is working to use other information "to inform decisions allowing the products to enter the U.S. market."
The outbreak of the new coronavirus from China, sweeping outward from the city of Wuhan, has the potential to disrupt the medical supply chain on multiple fronts. Factory closures and restrictions on travel could cause product shortages, while stockpiling and increased buying could limit availability or drive up prices.
Since personal protective equipment can block viral transmission, the FDA said it is aware demand for respirators and surgical gowns, masks and gloves could outstrip supply.
Hahn singled out protective personal equipment in particular as a group of products already affected by the response to the outbreak. If increased orders lead to shortages, the FDA plans to work with manufacturers to expedite products from new sources.
At the same time, the U.S. government's travel restrictions limit FDA oversight of a key region in the medical product supply chain. The regulatory typically conducts more than 500 inspections in China annually, across devices, drugs and food products. Travel to China now will only happen if it is deemed to be mission critical.
The FDA is balancing the lack of on-the-ground surveillance through the use of "other information."
"While the outbreak is impacting our ability to conduct inspections in China, it's important to underscore that the FDA's regular risk-based process of surveillance testing of imported products, including those from China, which is based on a number of factors, continues," Hahn said in the agency's update.
Most drug products imported from China are the active ingredients that go into small molecule drugs. Hahn emphasized that no vaccines, gene therapies or blood derivatives approved by the FDA are currently produced in China.
In addition to postponing inspections scheduled for February, Hahn said the majority of routine surveillance medical product inspections scheduled for March "at this time are expected to be conducted at a later date."