The Yale Law Journal

Barbara J. Evans


Deadly Delay: The FDA’s Role in America’s COVID-Testing Debacle

Barbara J. Evans & Ellen Wright Clayton

Recently, the FDA asserted authority to regulate a type of COVID-19 diagnostics known as laboratory-developed tests, which long have been a front line of response to emerging disease. FDA did not, and should not, have authority to regulate these tests. Its intervention added minimal value while cont…