An angry Azar floats plans to oust FDA’s Hahn

Infuriated by the FDA’s defiance in a showdown over the Trump administration’s standards for authorizing a coronavirus vaccine, health secretary Alex Azar has spent recent weeks openly plotting the ouster of FDA chief Stephen Hahn.

Azar has vented to allies within the Health and Human Services Department about his unhappiness with the top official in charge of the vaccine process, and discussed the prospect of seeking White House permission to remove him, a half-dozen current and former administration officials said.

During some of those conversations, he’s gone as far as to float potential replacements for Hahn, said one current and two former administration officials familiar with the talks, identifying HHS testing czar Brett Giroir and a pair of career civil servants – FDA Principal Deputy Commissioner Amy Abernethy and longtime regulator Janet Woodcock — as prime candidates to step in as acting commissioner should Hahn be removed.

The discussions come amid deep frustration with Hahn over his insistence that a Covid-19 vaccine meet strict safety standards — a contentious decision that rendered it impossible for President Donald Trump to fulfill his oft-expressed desire for a vaccine just before Election Day.

Earlier this month, Hahn ended a lengthy standoff over the rules under which the FDA would grant emergency authorization for a vaccine by flouting the White House and ordering their publication. The move won widespread praise from the nation’s public health community.

But it angered Azar and others who viewed it as the latest in a recent pattern of Hahn breaking with the broader administration in an effort to bolster his own reputation, current and former officials said.

White House officials are unlikely to green-light Hahn’s firing in the next two weeks despite their own reservations about him, five current and former administration officials said, over concerns about the optics of removing an FDA commissioner soon after his agency ruled out a pre-election vaccine.

Still, Hahn — who has endured a turbulent 10-month run — is viewed as a long-shot to return if Trump wins a second term. In a sign of awareness of his rocky standing, Hahn has largely avoided traveling to the White House of late, two administration officials said, preferring to call in to its coronavirus task force meetings.

In the meantime, the last few weeks have marked a new low point in an extraordinary feud between Azar’s health department and its subordinates at the FDA that has played out in the press and behind the scenes during the nation’s worst pandemic in 100 years.

That monthslong battle has disrupted efforts to combat the virus by slowing down internal decision-making and sowing confusion, according to 10 current and former administration officials and others with knowledge of the situation. It’s decimated morale and, at various times, forced the White House to intervene.

And at a time when the administration is fighting to develop the therapeutics and vaccines that can curb a disease killing 800 Americans a day, the Azar-Hahn feud has effectively severed the link between the two men at the center of that high-stakes effort.

“It’s broken,” one senior administration official said of the relationship between Azar and Hahn. “There is minimal interaction.”

In response to a series of questions, HHS and FDA spokespeople separately insisted that Azar and Hahn maintain a good relationship and speak regularly. An HHS spokesperson did not directly address whether Azar has discussed firing Hahn, and declined to say whether he still had confidence in his FDA commissioner, citing policy against conducting “personnel reviews in the press.”

On Thursday morning, after publication of this story, Azar told CBS that he has confidence in Hahn.

"Commissioner Hahn and I speak almost every day," Azar said. "We have a very close productive relationship and we're working together. As I have made very clear and the commissioner has made clear, the FDA will make the decision whether to approve therapeutics or vaccines according to their science, data, regulatory and legal standards, those calls will be made ultimately by the top career officials at the FDA and I 100 percent support that approach."

But six administration officials said the disintegration of the relationship between Azar and Hahn is the result of a series of disagreements, missteps and slights that began within weeks of Hahn’s arrival in Washington last December and steadily built to a boiling point. A radiation oncologist and longtime academic with no political experience, Hahn was thrust into the middle of a pandemic response just a month after becoming the agency’s latest leader — and the fourth in 2019 alone, after former commissioner Scott Gottlieb and acting heads Ned Sharpless and Giroir.

Hahn struggled to navigate the infighting and power plays that came with it. He clashed with HHS officials over personnel decisions, complicating plans to build out his own senior leadership team. When Azar took over management of the coronavirus response in January, Hahn was among several agency heads initially left off the Trump administration’s task force.

During those early months, Hahn spent much of the time deferring to other administration officials on how best to respond to the unfolding crisis – feeding frustration among career FDA officials and within the broader public health community over his perceived weakness as a leader.

One still-simmering dispute: whether FDA or HHS dropped the ball on enlisting the private sector to fight the outbreak.

As the coronavirus threat rose in late January, White House officials pressed Hahn to contact diagnostic manufacturers and begin coordinating the development of Covid-19 testing options, including potentially convening a roundtable discussion at which industry leaders would make public commitments. A senior FDA official also assured Azar that the FDA’s centers were pursuing planning efforts with the industry to develop coronavirus tests, said two people with knowledge of the conversation.

In a statement, FDA said that the agency had engaged the industry. "FDA staff were already conducting outreach to companies to offer assistance and understand any supply chain issues," a spokesperson told POLITICO.

But Hahn ultimately balked at convening the manufacturers themselves, two people with knowledge of the episode said, telling fellow officials that HHS had instructed him not to personally speak with companies that his agency regulated.

Azar and his allies have since furiously denied Hahn’s version of events, insisting that the FDA had a clear mandate and instructions to do what it took to aid the response, and that pinning the blame for a lack of testing resources on Azar would be "Kafkaesque," the health secretary told Wall Street Journal reporters in April.

“There is not a shred of truth to this,” an HHS spokesperson said. “Secretary Azar encouraged FDA to reach out to industry from the earliest days of the response.”

Officials at both FDA and HHS now concede that minor miscommunications at the start of 2020 — likely amplified by Hahn’s recent arrival in Washington and Azar’s own challenges dealing with internal department dissension and ramping up the coronavirus response — may have laid the groundwork for the delays and finger-pointing that followed for months.

But as critics zeroed in on the administration’s slow testing ramp-up as a key failure in allowing the virus to escape containment, those testing delays became a sticking point for Azar, who has complained that the FDA could have been more proactive in responding to Covid-19 – and that he should not have to micromanage the agencies under his department’s umbrella.

The public backlash set the stage for a series of disputes between Azar and Hahn that would drag through the spring and summer, souring relations between the two men and touching off what some administration officials saw as a series of leaks designed to shift blame away from the FDA – including on testing and, later, the botched rollout of convalescent plasma.

Stung by reports blaming his January declaration of a public health emergency for triggering FDA regulatory requirements that had hindered Covid-19 testing, Azar sought to revoke those requirements – which gave the agency the power to review the safety and accuracy of certain tests developed by commercial, university and public health labs.

The attempt met fierce resistance from Hahn and baffled officials within the FDA, who had only recently come under fire from HHS officials for allowing a flood of largely unregulated — and sometimes faulty — antibody tests onto the market.

The issue touched off what one former official termed “the war of the memos,” as HHS and FDA traded missives in a back-and-forth that ultimately pulled in the White House counsel’s office and prompted screaming matches between Azar and Hahn.

By the time Azar officially eliminated the FDA’s regulatory authority over the lab-developed tests – overriding the agency’s objections – there remained little trust between HHS officials and their counterparts at the FDA.

Azar, who has feuded with other health agency leaders including Medicare chief Seema Verma, increasingly suspected that FDA officials were serving as the source of damaging stories about the department and its coronavirus response. He grew irritated over a perception that Hahn often dealt directly with the White House – bypassing his immediate superiors at HHS.

FDA officials in turn lamented that they could not rely on Azar to reliably defend the agency, either internally or in the face of public criticism.

That left Hahn with little guidance in navigating a set of White House-level controversies. The FDA worked closely with White House officials in March and April to boost the availability of hydroxychloroquine, a malaria drug that had scant evidence for its effectiveness in fighting Covid-19, but had become one of Trump’s personal favorites.

The agency also rewrote its rules to expand access to an Ohio-based company’s mask sterilization technology amid a public pressure campaign from Trump and Ohio Gov. Mike DeWine.

Those decisions prompted widespread backlash among public health experts and inside the FDA itself, with staff worried that Hahn was sacrificing the agency’s long-held independence in the face of political pressure.

Hahn’s standing within his agency reached a nadir in August, when Hahn — alongside Trump and Azar — overstated the benefits of convalescent plasma as a Covid-19 treatment, enraging the scientific community and sparking calls for his resignation.

“The circumstances of your statements in recent days has led to a crisis in confidence,” Eric Topol, director of the Scripps Research Translational Institute, wrote in a blistering open letter shortly afterward. “Not only has your credibility been diminished but so has that of the FDA, its 15,000-plus staff members, and, most importantly, your ability to oversee the health interests of the American people.”

Hahn’s allies now describe the backlash to that press conference as an inflection point – one that prompted a concerted effort by the commissioner to re-establish the FDA as an independent agency and ally himself firmly with its career officials.

To Azar and other detractors in HHS and the White House, it marks the moment that Hahn went completely off the rails.

By the next day, Hahn had issued a lengthy apology, tweeting that “the criticism is entirely justified,” angering fellow political appointees who thought the FDA commissioner was magnifying the mistake and drawing attention away from a significant accomplishment by the president.

With just months until the election and Trump pressing for a vaccine, Hahn began publicly — and repeatedly — vowing to withstand political pressure and refusing to rush vaccines or other treatments. Inside the FDA, he increasingly deferred to career civil servants like Peter Marks, a senior regulator who’s taken a hard line with the pharma industry, said three people who have been included in discussions around vaccine development.

In a move that raised eyebrows throughout the administration, Hahn also began courting influential industry figures like Topol, a vocal critic of Trump and his administration’s Covid-19 response who has since become one of the FDA commissioner’s most ardent defenders. The two have since spoken several times, Topol said in an interview.

“I went from way negative to way positive,” he said, calling Hahn a “friend” who has had to withstand tremendous pressure from Trump and Azar. “He’s gotten wiser and has figured out how, even with all the adversity, he can figure out a way to do things right.”

As Hahn and Azar privately battled, seven former FDA commissioners — including Gottlieb, Trump’s first FDA commissioner — publicly blasted the Trump administration for what they framed as political efforts to rein in the agency. In a Sept. 29 Washington Post op-ed, the former commissioners criticized the White House and Azar for a series of recent decisions, including revoking the FDA’s sole authority to establish rules for food and drug safety. FDA scientists "should make decisions based on data, unfettered by political pressure or the intrusions of ideology or vested interests," Hahn's predecessors wrote.

Hahn’s two-week fight for the FDA’s stricter vaccine safety standards — capped by his unilateral decision to publish the guidelines without White House permission — served as perhaps the most emphatic step in the current commissioner’s rehabilitation tour.

Yet among those inside the administration, it’s a battle that officials say sunk his standing — and that even Hahn’s allies concede he’s unlikely to recover from.

“Hahn tried to satisfy the White House, now he’s trying to salvage his reputation,” said one person familiar with the current situation. “He should’ve kept his head down and done neither.”