9/16: "Right Up There with the Dumbest Things Ever": HHS Overrides FDA Authority Over COVID Test Development

 9/16/2020 

In an administration that seems like a clutch of serial killers in a clown car, HHS head Alex Azar is a standout these days for his actions involving the FDA. In Health and Human Services, they're supposed to work for the good of the American public, but Azar has decided to override the Federal Drug Administration's guardrails for keeping unsafe and ineffective pharmaceuticals off the market.

FDA protocols demand several rounds of stringent testing for new drugs and lab tests. Azar apparently decided that speed trumped caution for coronavirus tests. In August, he simply overrode the FDA's authority to oversee lab tests in development, including those for coronavirus.

Azar had loosened the FDA lab-test restrictions before, earlier this year, and the result was that ineffective and misleading lab tests were used on the public. Azar's August decision doubles down on that demonstrably bad earlier one.

The move didn't fall out of the sky. Test developers, not all of them commercial, have clamored for more flexibility for ages. Further, there was a putative legal basis for the move; HHS General Counsel Bob Charrow insisted that the FDA lacked the legal authority to regulate test development on an emergency basis. A former FDA Commissioner also told HHS that there was no clear path to approval under emergency circumstances.

However, Azar had to run over FDA commissioner Stephen Hahn to make the change, and while Hahn is a true expert in the field, Azar is simply a bureaucrat installed in his position by Donald Trump. The two had actual screaming matches before Azar announced his decision, and the FDA even refused to announce it, leaving that to the HHS.

Senate minority leader Chuck Schumer called on Tuesday for Azar's immediate resignation, saying "We need a secretary of Health and Human Services who will look out for the American people, not President Trump’s political interests.”

Meanwhile, a Republican close to the issue told Politico that HHS's decision to go to war with the FDA ranks "right up there with the dumbest things ever."


What are your thoughts? Is there any common-sense basis for rushing test development? Can HHS develop safe, effective COVID tests without the safety measures imposed by the FDA? Could this have happened under any other administration besides Trump's?

https://www.politico.com/news/2020/09/15/hhs-alex-azar-overrode-fda-testing-rules-415400?fbclid=IwAR1-gxNyCRDAewyhVfBIMOzL4pS0iqxV3a4FFjcG4rVnd_eakW2MB52DRcM