The Food and Drug Administration’s cumbersome and ossified approval process for drugs and tests stands out as a major cause of the federal government’s failure to quickly and effectively respond when the the COVID-19 virus first attacked. And one thing upon which all policymakers agree is that abundant testing—both for the presence of active infection and for evidence of previous infection and possible immunity—is crucial to ending this crisis.
As I have written here, on February 29 the FDA began to loosen these regulations, particularly regarding approval of tests, and allowed academic and commercial labs more freedom to produce and distribute them without having to follow normal FDA approval protocols. Finally, on March 16, the FDA delegated authority to the states to approve COVID-19 tests that may be used within their borders. The FDA should have also granted states this same authority to approve drugs that may treat the infection.
While the FDA has approved only a few antibody tests (which provide evidence of previous infection), many have been approved by state governments and have already been deployed. For example, an antibody test manufactured by California‐based Premier Biotech has been used by researchers at Stanford University and the University of Southern California to detect large segments of the populations of Santa Clara and Los Angeles counties who have already been infected by the virus.
In exercising the authority delegated to him by the FDA, Maryland Governor Larry Hogan announced yesterday that he purchased 500,000 tests from South Korea, a country that set an example of efficient and accurate testing when the virus attacked. The governor set the wheels in motion to purchase the tests from South Korea shortly after the FDA delegated authority to the states in mid‐March. It culminated in a chartered Korean Airlines flight that carried the test kits to the Baltimore‐Washington International Airport yesterday. The governor plans to deploy these kits to reach his state’s goal of testing 10,000 Marylanders per day.
Ironically, perhaps due to nationalist impulses, President Trump criticized Governor Hogan’s move. The president contended the governor should have used the tests available at federal laboratories—even though the governor was acting in accordance with administration policy. This was not the first time during this crisis that the president or his administration have transmitted mixed messages to the public.
One of the first questions that should have been asked in late February when it was discovered that the de facto CDC‐monopoly on COVID-19 testing was a fiasco was: Why not use the tests already successfully in use in other countries? As I wrote last month, a good policy reform that should emerge when this crisis passes would be for the FDA to grant reciprocal approval to all drugs and tests that are already approved and in use by a list of similar countries—and not just in time of emergency. That way the people won’t get deprived of drugs and tests to which they have a right.
In the meantime, states should continue to exercise their newly‐delegated power to decide on the tests that may be run within their borders and resist relinquishing this power once the crisis is over.