Trump undercuts FDA: The proposed guidelines slowing down vaccine approval sound "like a political move"

A leftover from last night that got lost in the shuffle because there was bigger news from this press conference.

This is big too, though. Read this for essential background if you missed it on Tuesday. The FDA is so alarmed by disintegrating public willingness to get a COVID vaccine once it’s available that they’ve proposed new guidelines that would slow down the approval process, requiring drug manufacturers to follow phase-three trial subjects for two months after they’ve received the vaccine to make sure it works and there are no side effects. They want Americans to trust that corners aren’t being cut to bring this product to market, which gets harder every time Trump offers an unrealistic timeline for approval. The entire country understands that he wants an emergency-use authorization from the FDA before Election Day so that he has something to crow about on the campaign trail. And most of the country is worried that any pressure he puts on the FDA to meet that timeline will force them into approving a vaccine that’s not ready for primetime. The FDA’s guidelines are an attempt to reassure the public that that won’t happen.

Trump doesn’t care about that. He wants his campaign talking point, so here he is grinding the public’s trust under his shoe by casually suggesting he might block the new guidelines so that the FDA has to work faster.

I speculated on Tuesday that Alex Azar and HHS were angling to block the new guidelines on his behalf, but no. According to Politico, the strict new FDA standards cleared an HHS review. The clip above is Trump taking personal ownership of a move that would make the vaccine approval process less diligent. And just as a further kick to the FDA’s groin, he openly speculates that “political” motives are driving the slowdown. The reality is the opposite: The FDA fears that the process has already been politicized to the point that the public has lost confidence in it and so they’re doing what they can to signal that science remains their top priority. Trump’s response is to politicize it further.

And not for the first time. In fact, his electoral motives are so obvious that even if the FDA ends up with encouraging data on a particular vaccine by late October and is otherwise inclined to authorize that vaccine for emergency use, they may worry that putting *anything* out before Election Day at this point — even a meritorious vaccine — will make the public so suspicious of political chicanery behind the scenes that it’ll do more harm than good. If Americans conclude that a vaccine released before November 3 is inherently suspect, whether that’s true or not, it’ll set back the cause of getting the country vaccinated next year.

The irony is that by impugning the scientists in charge of the approval process and signaling repeatedly that he’s on an election timetable, he’s going to end up negating any political benefit he might get from a vaccine being approved before November 3. No one’s going to trust a product that emerges before that date now; he might get a small burst of enthusiasm from hardcore fans who were already planning to vote for him, but there’ll be a thousand independent experts on TV lambasting him for having pushed through a vaccine that really should have been studied on a longer timeline, as the FDA had suggested. He’s making the same mistake here that he made by pushing to reopen businesses in April, when he decided that he had to get the economy going ASAP or he’d be sunk on Election Day. He’d be far better off politically now if he had gone a bit slower, as the public wanted, and made a show of the fact that he was putting Americans’ safety first. That would have boosted his numbers on handling the pandemic and the ensuing economic recovery might have been more durable since there may have been lower community spread after the delayed reopening.

What’s also weird is the idea that if he doesn’t approve the FDA’s proposed guidelines the agency might approve a vaccine more quickly. Is there any reason to believe that? Presumably the FDA can enforce the guidelines informally, taking their time in reviewing available data to give drug manufacturers a longer period to observe trial subjects. At the end of the day, Trump can’t force the FDA to approve anything or make them work at a particular pace. If he got frustrated and end up resorting to issuing an approval himself, over the FDA’s objection, it would be a fiasco. Even MAGA fans would balk at getting that shot. The backlash might cost him the election.

He’s at the mercy of his science bureaucrats whether he realizes it or not. What’s destined to happen here, I think, is relative quiet from the presidential Twitter account until mid-October, followed by a burst of browbeating sh*tposting once he starts to worry that they really aren’t going to have something for him before mid-October. That’ll do plenty of long-term damage to public confidence in the vaccine too, at least on the right: A true blue Trump fan can’t rightly get a vaccine that was held back by the “deep state” in hopes of costing him the election, now can they?

Andrew Cuomo announced earlier today that he’s going to form a panel of experts to perform its own review of vaccine candidates to make sure that they’re up to snuff scientifically and weren’t rammed through as some sort of campaign ploy by the president. On the one hand, that’s a perfect example of how bitter partisanship has become in America 2020: We can’t even trust the federal government’s scientists when they work for the other party. On the other hand, the whole reason the FDA took to proposing these “slowdown” guidelines is that Americans now have good reason not to trust that the vaccine approval process will be free from political interference. Cuomo’s panel might actually prove useful to the cause of getting America vaccinated if it reviews the FDA’s approved vaccine and says, “Yeah, this looks good to us too.” If the Republican White House says it’s safe and the Democratic governor’s science board says it’s safe, well, it must be safe.

Here’s the head of the FDA yesterday, forced into the surreal position of having to reassure Congress that he will not, in fact, let the president bully him into approving a bum vaccine that’ll affect the health of 330 million people.