From almost the moment the COVID-19 public health emergency was declared, the US Food and Drug Administration (FDA) has come under fire for not making better use of its emergency use authorization (EUA) powers to enable desperately needed SARS-CoV-2 diagnostic tests to market more rapidly. A new report from an outside management consulting firm hired to review the agency’s handling of the COVID-19 situation cites key weaknesses in the current EUA process and offers recommendations for remedying them. The EUA Process Section 564 of the Federal Food, Drug, and Cosmetic Act gives) gives the FDA the authority to authorize commercially developed new diagnostic tests on an expedited basis during declared public health emergencies. The EUA process allows for the development, validation, authorization and deployment of new tests in a matter of weeks, rather than months or years. COVID-19 is the sixth public health emergency in which the agency has drawn on its EUA powers. To date, the FDA has granted EUA for approximately 400 tests and home collection kits and over 1,700 medical devices designed for diagnosing, treating or preventing COVID-19. The 3 Problems with the EUA Process While those numbers sound impressive, they only tell a part of the […]