Nothing is every completely perfect. You have to a cost/benefit analysis. After assessing, having the FDA is far better than not having it. Far better. We actually did not suspend anything for the virus, a risk-based approach, which is what the agency uses anyway, was used. The concerns on testing are valid. We definitely need more tests distributed widely, but this pandemic showcases more about how good the biomed process including the FDA rather than the flaws. Of course it can be improved, but if we did not have the bizarre culture war around the vaccines this pandemic would be largly under control and our main concern would be getting vaccines to underserved countries to stop variants.
"Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives. The HHS declaration to support such use must be based on one of four types of determinations of threats or potential threats by the Secretary of HHS, Homeland Security, or Defense."
Source
Approvals occured promptly via a suspension of the normal course of business, as I said. Legal, yes. But normal approval processes were brushed aside, on an emergency basis. I happen to think the FDA delays too much - is too precautionary - as the Moderna and Pfizer approvals would seem to support, as well as the at home testing delays we are currently suffering.
Your argument seems to be FDA or nothing. Its a strawman. Moreover, its not the argument I'm making. Consider, for instance, safe storage of eggs for human consumption - a matter of importance here at BYC. Our FDA, and the health authorities in the EU have evaluated the same concern - how to get eggs safely from commercial hens to consumer use, and reached radically different conclusions as to "best processes". Both have ensconced their process into the relevant law. Those laws don't force "best practices" - the EU and the FDA processes aren't compatible. They merely force a process consistent with regulation. Whether or not its "best" is immaterial. Perhaps the regulations were best at the time of their crafting - perhaps not - for an assumed set of circumstances. If those circumstances change, or the assumptions prove untrue, revised regulation follows very slowly - and typically opposed by entrenched interests. That's the nature of the world.
I'd prefer a more nimble approach, even if it involves more risk.