Azar falls in line under Trump again. Experts say he's reinforcing a dark signal sent to the FDA
In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.
Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”
His full remarks:
Alex Azar: The guidance that matters is actually already out there. We put it out over a month and a half ago at the FDA. What FDA is looking at is actually just some additional guidelines for the manufacturers who might come in for emergency approval, it’s a fairly technical document…
Savannah Guthrie: Do you support it?
Alex Azar: Well we’ll look at it and determine if it’s appropriate but the guidance that matters is out there, and FDA’s gonna call these balls and strikes according to clear standards that FDA has. That is out there, the manufacturers know what’s expected, the statistical requirements, the safety, the efficacy.
Hours before Trump took to a White House podium yesterday and undercut FDA commissioner Stephen Hahn — calling the move to strengthen EUA rules as “extremely political” — Azar was reported to have spoken with the president. Politico reports the new standards passed muster at HHS on Tuesday and there was an expectation that it would get a green light from the White House.
It’s still possible Trump gives his blessing to Azar to allow the FDA to issue the stringent new rules. And some observers note that FDA can tell sponsors what’s required without publishing the guidance, making it public later. But with intense global scrutiny on these trials, and the names of the leading vaccine makers firmly implanted in the president’s lexicon, it’s unlikely the FDA could do so without attracting Trump’s ire. And with each passing incident where Azar clearly picks the side of the president over the very public wishes of FDA, he risks new episodes that could further weaken the agency’s credibility and its ability in the eyes of the American public to vet the safety and efficacy of Covid-19 vaccines arriving at Warp Speed.
Impacts of the Azar memo
This all comes on the heels of Azar’s stunning memo last week that stripped the agency of its rulemaking powers, declaring all of that “is reserved for the Secretary.” HHS officials repeatedly claim the memo was simply a measure of “good-governance” that would have no impact on drugs or vaccines, but help protect against lawsuits.
Experts, though, say that while technically correct, HHS’s statement belies a more complicated reality and that their justification for the memo is flimsy at best.
The memo doesn’t formally change who has power over vaccine and drug approval, but it reinforces a signal given throughout the pandemic: “That Secretary Azar wants to be very clear that he has final word on decisions coming out of the FDA,” Micah Berman, a former FDA advisor and a professor of public health and law at Ohio State University, told Endpoints News.
Although the FDA has historically operated as a largely independent agency, HHS legally has final say on its decisions. HHS secretaries have rarely exercised that authority, but Azar did so last month, stripping the agency of its ability to regulate lab-developed Covid-19 tests.
The timing of the memo and its form could have significant ripple effects on the agency and its employees, two former FDA officials told Endpoints.
Former associate commissioner Peter Pitts defended Azar’s rationale, calling it an understandable move for accountable and streamlined government but one that was timed badly, guaranteed to sow confusion and feed pre-existing concerns about the Trump administration meddling in the agency.
“From a timing perspective, it only adds grist to the mill that the FDA is politicized, which is incorrect factually and unfair personally,” Pitts said.
‘A slap in the face to the people at the FDA’
In an interview, Peter Lurie, who now runs the Center for Science in the Public Interest, said the memo wouldn’t impact guidelines or decisions — the main way the FDA has influences on Covid-19 policy — only more minor regulations. But these decisions already get cleared through the FDA rungs, he said, even if a lower level official gives the signature.
“Imagine putting out a big rule without telling the secretary? It’s just preposterous,” Lurie told us. “I think this is a slap in the face to the people at the FDA. I think the administration’s disdain for public employees is apparent in this.”
Functionally, the memo changes longstanding practice at the agency, where lower level officials can sign off on rule changes without the signatures of the FDA commissioner or HHS secretary. HHS says the memo “minimizes litigation risk,” an apparent reference to arguments advanced by conservative groups that potentially thousands of FDA rules are illegal because, they claim, the Constitution’s appointments clause only allows officers directly appointed by the government to sign regulations.
In the case of Moose Jooce, et al. v. FDA, et al., the vaping company argued that the FDA’s 2016 regulatory framework for vaping devices was unconstitutional because it was signed by the FDA’s Leslie Kux as opposed to the FDA commissioner. Gottlieb signed it in 2019, adding in a note that said the signature did not mean it had previously been illegal.
A federal court, though, decided against Moose Jooce earlier this year and denied their motion for expedited appeal. And the former officials said if HHS was concerned about it, they could have acted years earlier, and they could have made the policy that the FDA commissioner, who is also directly appointed by the president, signs off on all rules.
“As far as I know, none of that litigation has been successful,” Berman said. “It’s not clear that it was a legal threat in the first place.”
So what will this mean logistically inside the FDA? It’s not clear yet. Passing every rule through Azar could cause an administrative headache, as former FDA commissioner Mark McClellan has warned. Lurie, though, noted that the rules aren’t signed on a daily basis, so it may not prove a significant burden.
There was also concern that the memo would validate Moose Jooce’s argument and potentially invalidate thousands of FDA rules, though Berman said that would require individual challenges to each rule. Moose Jooce, meanwhile, is carrying on with their appeal. They gave oral arguments at the DC Circuit Court of Appeals on Wednesday.
Jonathan Wood, who is arguing the case for the Pacific Legal Foundation, said he welcomed the memo. But he too was wondering about the timing and said he had his own theory.
“This has been an issue HHS has known about for years, at the very least since we filed the complaint several years ago and throughout the process of litigating this case, they’ve said this is totally fine, we’re not going to stop it, continue to have employees issue rules,” he told Endpoints. “Maybe it’s a coincidence that they suddenly changed the practice one week before the DC Circuit heard oral arguments?”