This morning, NBC Think published my opinion column discussing the sclerotic and disorganized initial response of the federal public health system to a building coronavirus pandemic.
In my column, I point out how the Food and Drug Administration’s cumbersome regulatory process resulted in a single, government‐monopoly coronavirus test, made available in limited supply, by the Centers for Disease Control and Prevention.
This process kept the private sector and foreign‐developed tests out of the process during the crucial weeks between when the first virus was identified in December and when it started spreading throughout the U.S. Meanwhile, when the tests were initially rolled out, they were found to be defective, forcing the CDC to play catch up getting new, corrected tests out to the public.
All of this was happening while other countries were already relying on tests developed by numerous private sector companies and organizations, operating under more liberal regulatory regimes.
The World Health Organization distributed a test developed by a Berlin biotech firm to 57 countries and China had five commercial tests on the market in January. South Korea enacted a reform after suffering a devastating attack of Middle East Respiratory Syndrome (MERS) in 2015 that grants nearly immediate approval of testing systems in the event of an emergency.
While the rest of the world sought to benefit from and enable private sector initiatives, the U.S. embraced a top‐down command‐and‐control approach to the present biomedical challenge, replete with red tape and poor communication with local public health officials. This is not only tragic and unacceptable. It’s embarrassing.
Only in recent days has the FDA relaxed its stringent approval process and encouraged a rapid private sector response.
Read more at https://www.cato.org/blog/detached-inflexible-regulatory-system-caused-flat-footed-response-coronavirus-outbreak
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