%22regulatory state is failing%22
A number of commentators suggest that the real problem is President Trump, rich people overly concerned with tax cuts, a Republican Party with a deregulatory ideology, and so on.
Instead I have been repeating insistently that “our regulatory state is failing us.” The FDA and CDC, for instance, have through their regulations made it harder for testing and also widespread mask supply to get off the ground.
I don’t see how you can blame (supposed) deregulatory fervor for the presence of too many regulations, as we have been observing in these instances.
I do think you can blame President Trump, along multiple dimensions, for a poor response to the pandemic, see my grades here. (If there were a separate risk communication grade, Trump would get an F minus for that.) Nonetheless a regulatory state cannot be said to work well if it requires such extraordinary attention from a sitting president.
It can be the case that both Trump and the permanent bureaucracy are at fault. If something takes a long time to get done for reasons relating to preexisting rules, regulations, and laws, usually the current president is not directly at fault for that particular problem. Was it only Trump’s fault, for instance, that the permits to build a mask factory can take months to acquire? Or that the HHS did not respond to inquiries about gearing up mask production in Texas? Or that a law had to be changed to allow industrial companies to sell quality masks to hospitals? Or that so many a-legal or extra-legal activities (e.g., rich people arranging deliveries by plane, etc.) had to occur to sneak masks into this country? That the trade barriers on masks persisted for so long? (And yes likely the Trump administration is at fault for de facto toughening restrictions on masks from China.)
It is fine to say “the buck stops here,” and to criticize Trump for not having erected processes to be more aware of these problems and to dissolve them more quickly. I would agree with some of those criticisms, while noting the Trump administration also has tried to ease many of the regulations hampering adjustment.
This is more something on the horizon, but how do these apples make you feel? Comforted? The fault of plutocratic Republicans most of all?
And in both cases, vials and stoppers, a vaccine manufacturer cannot just switch to a slightly different product or another brand. They typically have to run manufacturing changes by FDA first, which could make quick supplier changes to curb shortages a difficult prospect.
The FDA can decide how flexible it will be about this type of change, says Sklamberg. The agency said in a December 2017 draft guidance that companies could note some changes in their annual reports rather than waiting for approval, but it has not finalized the policy.
The ability to switch products could be crucial as the entire world readies for a possible vaccine and vies to secure their supplies.
If you wish, consider a simple question. When the CDC pooh-poohed masks early on, or botched their testing kit thereby delaying U.S. testing by weeks or maybe months, did the permanent staff of the CDC rise up and rebel and leak howling protests to the media, realizing that thousands of lives were at stake? That is surely what would happen if say the current FDA announced it was going to approve thalidomide.
Those are still cases of our regulatory state failing us.