Maryland Acts in Support of the “Right to Test”

Jeffrey A. SingerThe 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 writtenhere, 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 thestates 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 hasapproved only a few antibody tests (which provide evidence of previous infection), many have been approved by state governments and havealready been deployed. For example, an antibody test manufactured by California ‐​basedPremier Biotech has beenused 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 ex...
Source: Cato-at-liberty - Category: American Health Authors: Source Type: blogs