29 September 2020 - The FDA has issued a number of contentious decisions during the COVID-19 pandemic related to investigational products.
The controversies that continue to swirl around these decisions stem in part from the agency’s lack of transparency, including its limited explanation and disclosure of the evidence on which it based these decisions.
When the FDA issued an emergency use authorisation (EUA) for hydroxychloroquine and chloroquine in March, for example, it did not describe the details of the extremely limited evidence supporting its decision. The FDA revoked that EUA in June.