The U.S. Food and Drug Administration inspects a few thousand drug manufacturing plants every year to ensure their standards are up to par. Many of those inspections are required before a pharmaceutical company can gain approval of a new drug. They serve as a check on whether drugmakers can produce quality therapies.
But that won’t be the case for Covid-19 vaccine developers that gain emergency authorization of a shot.
FDA regulations don’t require what’s known as a pre-approval inspection for products seeking emergency use, said Jerry Weir, director of the Division of Viral Products in the FDA’s vaccines office. Weir spoke last week at a meeting of FDA advisers to discuss standards for Covid-19 vaccines.
Before approval, FDA inspections ensure compliance with regulations. Once a product is being made—as vaccines already are to get them out as quickly as possible—they can uncover quality breaches and assess whether pharmaceutical companies handled them correctly or are possibly downplaying or ignoring serious issues.
Hellbound and Down 