Notes and Thoughts

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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 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 fifteen person team to completing the FDA approval application, working fifteen hour days for three weeks.

Despite the important of speedy action, the FDA 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.

Additionally the FDA, in a truly ridiculous example of process over sanity, has persecuted groups that 'misused' tests.

  • The FDA barred the Seattle lab that first identified community transfer of the Coronavirus within the US because they didn't have the correct institutional 'designation'. When they did so anyway the FDA ordered 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 the 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, and continued to prioritize the precision of the tests over the speed of results. One can't help but feel this is a projection of the agencies internal processes.