The FDA's Role in Drug Regulation

The FDA has developed in its role of guarding with drug innovation against the possibility that an ineffective or harmful treatment would get widely disseminated. We are now in a pandemic and the risk benefit calculus is very different with respect to the regulatory function. What should trigger disapproval in this environment should be much, much, much more higher threshold than what would trigger disapproval in the conventional drug regulation environment. As a consequence, the FDA is now an impediment to effective public health overall.