FDA Suspends GMP Inspections But All Other Tasks Continue
​​[Thursday, March 12, 2020]
FDA announced this week that it is cancelling all scheduled foreign inspections and limit domestic travel only to mission critical functions essentially stopping all inspection activities to address the spread of coronavirus infection. This is an extension of last week’s announcement where FDA cancelled all inspections in China. During this time, FDA would rely on document review, previous experience with these products and alternate means to verify product quality. At the same time, since almost everything else FDA personnel does can be done remotely, FDA will continue almost all other activities such as review of applications, phone meetings, and release of documents through its various channels. One should expect fewer in-person meetings, though. While FDA has not yet announced any delays in PDUFA dates or cancellation of Advisory Committee (Ad Com) meetings, but its Ad Com meeting scheduled yesterday and on 2nd April have been postponed indefinitely. The PAIs have also been postponed most likely delaying the affected applications. At the same time, FDA is dealing with scrupulous players trying to take advantage of the scare by selling dubious products. Just this week, FDA announced Warning Letters to several companies illegally selling products intended to treat or prevent Covid-19. And that’s just a drop in the ocean. The social media and internet is rampant with all kinds if products, advise, and anecdotes from all kinds of people claiming to know how to fight the virus. And almost all are fake at best and dangerous at worst. FDA would have to deal with these but for now it would be hard. With the travel restrictions expanding nationwide, health supplies dwindling, and public in fear, the government will need to be restrained to only go after critical events. So far, the US government has played catch up with the rest of the world. The kind of restrictions imposed in Italy should have been imposed in Seattle and other nuclei of the infection early on. It seems that now the virus has spread wider and may be harder to contain before it dies naturally either due to the arrival of warmer weather, as many predict, or more people developing natural immunity. More than 98% of infected individuals survive the infection. For the regulated industry, this presents a test of the ability of the regulators to manage broad infections without mismanaging the rest of the system. At present the best option is the wait it out. The manufacturing facilities are probably the cleanest and safest place to work, so people working in GMP facilities should continue going to work. Others should work from home where you can.