It’s impossible to read this story and not assume it’s yet another attempt by the White House or one of its arms, in this case HHS chief Alex Azar, to politicize the scientific process as we inch closer to a COVID vaccine and Election Day. They’ve been strong-arming the CDC on things like guidance for testing of possible asymptomatic patients; Trump himself has personally and publicly strong-armed both the head of the FDA and the head of the CDC. Now, six weeks out from the election, with Trump making Trumpy promises every day about the vaccine’s supposedly imminent arrival, one of his political appointees has suddenly pulls a “stunning” surprise on the federal government’s scientific arms. Normally agencies like the FDA enjoy a delegation of authority from HHS to issue rules on food and drugs without approval from higher-up. That’s now changed: Azar, who answers directly to Trump, has to sign off on everything personally, effective immediately.
But here’s the wrinkle. If this is all about giving Trump more direct control of any forthcoming announcements about the vaccine (or therapeutic treatments like monoclonal antibody drugs), *how* does the new rule do that, exactly? Trump’s priority right now is speed. He wants to be able to report new breakthroughs on COVID to the public as soon as possible, but in any event no later than November 2. All Azar’s rule does is inject him as a new layer of bureaucracy into the approval process, which … slows things down. Granted, it slows things down only negligibly — Azar’s review of an FDA decision approving a vaccine would presumably last no longer than five seconds lest the boss be mad at him — but if the White House were playing games with the FDA, you wouldn’t expect them to be adding new hoops for the agency to jump through en route to setting rules. You’d expect them to be removing them. Cutting corners is what people are afraid of in developing the vaccine, not adding extra layers of scrutiny.
What’s the play here, then? Why are they doing this now?
Many rules issued by federal health agencies are signed by lawyers or by the heads of agencies, including the F.D.A., under the umbrella of H.H.S. The new memo requires the secretary to sign them, which Dr. Lurie said could lead to delays in the regulatory process.
“It will introduce an element of inefficiency within government operations that is wholly unnecessary and likely to gum things up,” he said…
[F] ormer senior officials with the F.D.A. and H.H.S. speculated that the intent was to remove rule-making power from Dr. Stephen Hahn, the F.D.A. commissioner and to send a signal to President Trump that no surprises would come from the agency in the weeks before the election.
“I can only conclude that this memorandum shows a lack of trust in the F.D.A. commissioner and other H.H.S. leaders,” said William B. Schultz, a former general counsel with H.H.S. and a partner at Zuckerman Spaeder, a law firm.
Right, but which surprises? The Times admits candidly that it’s “unclear if or how the memo would change the vetting and approval process for coronavirus vaccines.”
I think it’d require an expert on administrative law to comment intelligently on the implications of Azar’s move but I can imagine three scenarios in which it might conceivably help Trump achieve some of his political goals.
1. Maybe it gives Azar more power over the CDC, specifically more power to bottle up new CDC pronouncements that conflict with Trump’s political message. The guidance on testing of asymptomatics was a classic example. Trump has complained that our case counts are higher than the rest of the world’s because we test so much; go figure, then, that HHS would revamp the guidance to downplay testing of people with no symptoms. The whole reason Trump appointed loyal crony Michael Caputo to be HHS’s press secretary was, apparently, because he didn’t trust Azar to look out for his political interests in the scientific arm of the federal government the way he trusted Caputo. Now that Caputo’s on a leave of absence, maybe Azar’s stepping in to fill the breach. From now on, perhaps CDC has to run their new pronouncements on COVID through him first — which may explain why their admission that aerosols are the main way the virus is transmitted was strangely yanked off the website today.
But as I say, we’d need a lawyer here. Does the CDC’s guidance on aerosols and asymptomatic patients even count as a new “rule” for purposes of Azar’s memo?
2. Maybe the fact that Azar is now directly in the chain of approval when a new rule is issued gives him greater access to internal deliberations at the FDA and CDC, which could be politically useful to Trump. Again, we’d need someone who knows the regs to opine on that. But it could be that the fact that Azar’s signature is now required before a new vaccine is approved means that he can request documents, etc, as the approval process is ongoing in order to get a sense of whether the vaccine looks promising, when approval might be granted, who’s an impediment to approval, and so forth. Then he could relay that information to Trump so that Trump can boast about progress on the campaign trail. Or Azar could relay it to reporters, leaking the news of how far along a vaccine candidate is in order to generate good headlines for the boss.
That is, maybe this is a sort of intelligence operation. Azar realizes that a vaccine probably won’t be authorized for emergency use before Election Day so he’s going to use his authority over the FDA to find out what he can before that. Obvious question, though: Didn’t he already have that power as the head of HHS? If he called up Hahn last week, before the new policy was issued, and said, “I need an update on the vaccine, Steve,” was Hahn really going to say no?
3. Maybe Azar’s worried about the FDA rejecting a vaccine before Election Day. I wrote yesterday about potential problems with the Oxford vaccine in AstraZeneca’s UK trial. If Oxford sought authorization by the FDA for its vaccine and the agency decided “nope, too risky,” that would be a terrible pre-election headline for Trump. It would shake public faith temporarily that an effective vaccine will ever be developed. Voters might blame him for the vaccine’s failure. And Trump would unquestionably make things worse by trying to browbeat the FDA about its decision publicly. Azar might be calculating that if there’s a chance that the FDA might nuke a vaccine before November 3, he could bottle that decision up by refusing to sign off on it until after the vote, thus sparing his boss from real political trouble.
But wouldn’t the decision leak? Why would FDA scientists show loyalty to Trump after he’s tried to bully them, especially now that they have reason to resent Azar for micromanaging them?
Here’s where these endless political machinations involving the FDA and CDC have gotten us, by the way:
Fewer than 1 in 10 (9%) Americans have a great deal of confidence in Trump to confirm vaccine effectiveness with another 18% reporting only a “good amount” of confidence in the poll conducted by Ipsos in partnership with ABC News using Ipsos’ Knowledge Panel. In contrast, 69% don’t have confidence in the president vouching for a vaccine, including 16% saying “not so much” and 53% saying “none at all.”
Sixty-nine percent is a mind-boggling number on a question about basic presidential credibility. Normally you can count on 42 percent of the country to give the most Trump-friendly answer to any poll question you ask them. He’s handled COVID so badly that he’s even lost a meaningful chunk of his base on an issue as important as whether you’d trust him on a drug designed to protect you from a killer disease.
Scott Gottlieb, a former head of the FDA, was asked yesterday on “Face the Nation” what he makes of Azar’s new rule. “To do this now just makes no sense,” he complained, adding, “This does create an implication that … the independence of that agency is being eroded or influenced.” (The agency’s independence *is* being eroded, my man. Quite openly.) Another former FDA chief, Mark McClellan, criticized Azar’s move as well, telling the Times, “We’re in the midst of a pandemic, when trust in the public health agency is needed more than ever.” What’s Azar’s game here?
“This was the wrong move at the wrong time,” @ScottGottliebMD says of a key shift at @HHSGov barring agencies from signing new rules affecting medical products and vaccines
"This does create an implication..the independence of that agency is being eroded or influenced" pic.twitter.com/9uG2lODDeE
— Face The Nation (@FaceTheNation) September 20, 2020