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FDA to Postpone Some Inspections of U.S. Manufacturing Facilities

By Mark Prvulovic - Mar 19, 2020 at 5:51AM

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At first, the inspection suspension was for all non-U.S. facilities. Now the FDA is dialing back on domestic inspections, skipping those deemed not 'mission critical.'

As COVID-19 continues to spread, many companies and organizations are encouraging their employees to work remotely. This also applies to a number of U.S. regulatory bodies, including the U.S. Food and Drug Administration (FDA). On Wednesday, the FDA announced that due to many of its employees working remotely, it would be postponing routine inspections of American manufacturing facilities.

In 2019, the FDA conducted almost 12,300 inspections in the country across a variety of healthcare product categories, including drugs, medical devices, cosmetics, veterinary products, and more. However, the agency has decided to halt inspections due to safety concerns regarding its employees as well as preventing the potential spread of COVID-19. It will still conduct inspections it considers to be "mission critical."

Someone holding a magnifying glass to look at a bunch of generic pills.

Image source: Getty Images.

The FDA announced last week that it was postponing all foreign inspections due to the COVID-19 pandemic. Although the agency said at the time that this would be just until the end of April, it seems likely that the agency will continue to postpone foreign inspections indefinitely, considering that even domestic inspections have been put on hold for the most part. Although FDA personnel won't be visiting manufacturing sites, the agency said it's considering alternative methods of conducting inspections, such as reviewing records.

The FDA's decision could hinder new drugs from getting to market in the near-term.

Remote work is here to stay

Companies are urging all employees who can work remotely to do so for safety concerns. Amarin and Pfizer told their sales teams to work remotely to prevent possible infections, with many other businesses following suit. Pharmaceutical companies that haven't already made similar adjustments to allow remote work will likely do so soon. And with salesforces on the sidelines, at least physically, pharma companies could see their revenues dampened for the next few quarters.

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