Reversal: After objections from Trump, White House approves FDA guidelines to slow down vaccine authorization

Serious question: Does the president know about this?

I ask not because he’s been preoccupied with other matters the past few days but because he made his feelings about the prospect of the FDA “slowing down” vaccine approval pretty clear a few weeks ago.

Let’s back up. Late last month, news broke that the FDA had proposed new guidelines for approving a COVID vaccine. Read this for background. The most notable element of the proposal was the recommendation that subjects in vaccine trials be followed for a median of two months after they receive their second dose so that manufacturers can be confident there are no late-developing side effects from their products. That was the FDA’s attempt to depoliticize the vaccine process by inserting some extra scientific rigor into it. If Americans are worried about the government cutting corners and rushing a vaccine to market prematurely in order to help Trump’s campaign then the way to rebuild confidence is simple: Slow down. Show the public that you’re being diligent by taking extra time to make sure that the vaccine is effective and safe.

A two-month study period, though, would mean little to no chance of any vaccine being approved before Election Day, which would mean no October surprise for Trump. The president was asked on September 23 how he felt about the idea of his government slowing down the authorization process. Answer: Not great. True to form, he even impugned the FDA’s integrity by claiming that the slowdown might be politically motivated.

The FDA submitted its proposed guidelines to the White House for approval anyway. That approval is normally granted as a matter of course, but not this time. Mark Meadows reportedly demanded that the agency explain in detail why it wanted to slow down the process now, after trials had begun. Some experts were taken aback. “I don’t know of any precedent where the White House asked to adjudicate scientific and clinical guidances, even in past public health emergencies,” said former Trump FDA chief Scott Gottlieb to WaPo. “To build trust among patients and providers, you wanted to leave these matters to the FDA process, which has a lot of rigor and integrity.” Last night the Times reported that the White House was still blocking the new guidelines, allegedly because it objected to the two-month slowdown period. To all appearances, Trump and Meadows were going to force the FDA to stick to an accelerated timeline for authorizing a vaccine because Trump wants a big vaccine “reveal” for his reelection bid.

But it’s not that simple, it turns out:

Facing a White House blockade, the Food and Drug Administration is seeking other avenues to ensure that vaccines meet the guidelines. That includes sharing the standards — perhaps as soon as this week — with an outside advisory committee of experts that is supposed to meet publicly before any vaccine is authorized for emergency use. The hope is that the committee will enforce the guidelines, regardless of the White House’s reaction

That Wednesday, Mr. Meadows raised a series of concerns, a senior administration official said. He questioned the need for two months of follow-up data, said that stricter recommendations would change the rules in the middle of clinical trials and suggested that Dr. Hahn was overly influenced by his agency’s career scientists. The White House on Monday did not respond to a request for comment…

Some vaccine makers, including Johnson & Johnson, have publicly indicated that they will follow the agency’s recommendations, regardless of the White House’s actions.

It sure sounds like there was something of a quiet mutiny here by the FDA. Two weeks ago, when the White House first started making noise about the new guidelines, I wondered how they could possibly force the FDA to follow an artificial timetable for authorizing a vaccine. Even if the guidelines weren’t formally approved by the president, scientists at the agency — and scientists at the manufacturers — will work at the pace they choose to. If both sides agree that two months of observation for trial subjects is appropriate then that’s what’s going to happen, even if Trump is angrily tweeting about a “deep state” conspiracy between them or whatever. And as the Times notes, the FDA had a ready-made excuse for an eventual slowdown: The independent advisory committee, which the public will be looking to for guidance on whether the vaccine is safe, could simply declare that no vaccine should be authorized until two months of observation have been recorded. If Trump somehow forced the FDA to approve a vaccine before Election Day and then the committee pronounced it premature and not ready for prime time, that would spoil any electoral benefit he might be hoping to gain from the authorization.

So maybe the FDA told Meadows, “You can approve the guidelines or block them, but we’re doing it on our timeline one way or another.”

And maybe Meadows, realizing that he wasn’t going to win here — and realizing that the events of the last few days have further damaged public trust in the administration’s handling of COVID — decided that he may as well approve the guidelines, then. If he can’t force the FDA to speed up, he might as well pocket the political (and public health) benefit from being able to say, “Yeah, we’re slowing down. We’re going to do this the right way and make sure the vaccine’s safe and effective.” Word came this afternoon that the FDA has now published the guidelines, which apparently means the White House signed off after all:

The White House endorsed the U.S. Food and Drug Administration’s plans for assessing whether a Covid-19 vaccine should be given widely, casting aside objections to requirements that would likely mean a shot won’t be cleared until after Election Day, people familiar with the matter said.

The FDA promptly issued the guidelines on Tuesday afternoon, saying it hopes the release “helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved.”…

[T]he FDA had already given the guidelines to companies and told them to expect their vaccines should meet the standards in order to secure authorization.

Unless I’m misunderstanding this, the FDA essentially told Meadows, “Here’s how it’s gonna be, Mark,” and went about their business as if the guidelines were in effect, even notifying manufacturers. Meadows ended up with no leverage to make them behave differently, knowing that the more the White House made a stink publicly about the slowdown effort, the more it risked eroding any political benefit it might eventually receive from a vaccine authorization. I doubt Trump would get much of a bounce even if the FDA approved a vaccine tomorrow, but he’d get no bounce if that approval was made under circumstances which all parties — the FDA, the manufacturers, and the advisory committee — believed were dubious and politically motivated. It would probably even cost him in the polls. In the end, what choice did Meadows have except to roll with what the FDA wanted to do?

Which brings us back to the question I asked up top. Did Meadows sign off on this or did Trump sign off on this? I can imagine Meadows acquiescing in the result of a battle against an agency which he’s fought and lost. I can’t imagine Trump doing so. I also find it hard to believe that this issue has been a priority for the president over the last 72 hours as he’s fought for his life against COVID. My guess is that Meadows or some other deputy finally gave the okay and that Trump hasn’t heard about it yet — and that he won’t be happy when he does. Last night he said in his Twitter video on the White House balcony that a vaccine is coming “momentarily.” Not anymore.

Either way, we’re destined to get some angry tweets about why it’s taking so long to approve a vaccine starting a week or two from now. Just because the president can’t force the FDA to produce the vaccine before November 3 doesn’t mean he can’t go on undermining the credibility of the process by accusing government scientists of being partisan operatives. Stay tuned.

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