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The fda's perpetual process machine

Categories #Article
Author Paul Romer
Source The FDA's Perpetual Process Machine
Related to FDA Bad Institutions

The FDA approved a broken test from the CDC extremely quickly. It has then hamstrung other tests through onerous and unnecessary paperwork. For example a rapid response team from the Mayo Clinic had to devote a third of their 15 person team to complete the application, working 15 hour days for three weeks.

They rejected an application from one team that spend hundreds of hours on it because the team failed to mail a hard copy of it to a separate office.

The FDA has persecuted groups that 'misused' tests.

  • The Seattle lab that first identified community transfer within the US was barred from running Coronavirus tests because they didn't have the correct designation with the FDA. When they did so anyway the FDA instructed them to stop, despite the obvious value of the information.
  • Groups that could test for the Coronavirus were told they had to wait until they received a clinical lab designation, a process that could take weeks or months. This is even after the FDA said they would shorten and expand the certification process.

People underestimate the chilling effect that uncertainty has on business investment decisions.

In May (!) they shut down home testing protocols as the agency hadn't authorized those tests.