The Food and Drug Administration has a plan -- in the U.S. and abroad -- to tackle the issues caused by the COVID-19 coronavirus that's infected tens of thousands of people in China.
As manufacturing has come to a standstill in China, the FDA is concerned about the supply chain coming out of that country. There aren't any FDA approved vaccines, gene therapies, or blood derivatives manufactured in China, but the country does make raw materials used in manufacturing of therapies.
"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 agency said in a statement released on Friday.
The FDA is monitoring the potential for shortages of protective equipment with increased purchasing in anticipation of the outbreak potentially moving to the U.S.
The agency is responsible for inspecting manufacturing plants overseas, including in China, where inspections have been stopped because of the State Department's travel warning. Fortunately around 90% of the inspections in China scheduled for February were of the routine surveillance variety, so the agency has just postponed the inspections.
The FDA is in charge of approving any potential vaccines or treatments for the COVID-19 coronavirus, but the agency's statement didn't mention any of the drugs or vaccines being developed by Johnson & Johnson (JNJ 0.87%), Gilead Sciences (GILD 1.06%), Inovio Pharmaceuticals (INO 2.81%) and others, suggesting that the agency thinks it's too early in the process to mention.
The agency did highlight the development of diagnostic tests for the virus, clearly a more immediate issue, with the FDA highlighting that it had issued an emergency use authorization (EUA) to allow the Centers for Disease Control and Prevention to use a new test for the virus. The agency has also given an EUA review template to more than 50 healthcare entities that are interested in developing diagnostics for the virus.