Given the death, suffering, social disruption and economic devastation caused by COVID-19, there is an urgent need to quickly develop therapies to treat this disease and prevent the spread of the virus.
But the Food and Drug Administration, charged with the task of evaluating and deciding whether to approve new drugs and other products, has a problem. The FDA’s standards appear to be dropping at a time when rigorous regulatory review and robust oversight are crucial.
For example, on March 28, the FDA granted emergency use authorization (EUA) for chloroquine phosphate and hydroxychloroquine sulfate, despite the drugs having known safety concerns and negligible evidence of efficacy in treating COVID-19.
As a specialist in bioethics and public health, I see troubling signs that suggest the FDA’s new program for expediting reviews of potential therapies for COVID-19 is not working as it should. Instead, its regulatory oversight has been weakened. In its place, I see signs of political interference, inappropriate pressure to authorize products for emergency use, and an overwhelming surge of clinical studies that challenges the FDA’s capacity to carefully scrutinize them before deciding whether they should proceed.