How the FDA stood up to the president

On Sept 23, Dr Stephen M Hahn left a virtual meeting of the White House’s coronavirus task force to take a call from the president’s chief of staff, Mark Meadows.

Meadows was angry with Hahn, head of the Food and Drug Administration, for pushing new guidelines for vaccine developers, according to two senior administration officials familiar with the call who requested anonymity because they were not authorised to discuss it. The FDA wanted to require two months of follow-up data to make sure a vaccine was safe and effective, all but ensuring one would not be ready by Election Day as President Donald Trump had promised.

Meadows told the commissioner the White House would not sign off on the guidance because it was unnecessary and would delay vaccine approval, so he should drop it, the officials said.

Hahn had been overruled by the White House before, most notably when the agency caved to the president’s desire to authorise malaria drug hydroxychloroquine to treat COVID-19 despite a lack of evidence. This time, stung by embarrassing scientific misstatements he made at a news conference in late August and concerned about the imperilled scientific credibility of the agency, Hahn would not be as obedient.

Meadows; Jared Kushner, the president’s son-in-law and senior adviser; and the president himself have called Hahn directly to urge him to speed up emergency authorisation of vaccines and treatments, according to the two senior administration officials.

But despite the White House refusal to approve the new vaccine guidance document, the FDA published the guidelines in briefing materials to an advisory committee that will discuss them Thursday, effectively making them official. And nearly two weeks after Trump called the antibody treatment he received when sick with COVID-19 a miraculous “cure” and said that he had authorised it, the FDA has not yet approved it.

Internally, Hahn has tried to erect a shield between his staff and White House officials, asking that all calls be routed directly to him and not to his staff. His situation is especially fraught because Trump has openly accused the FDA of engaging in political ploys to harm his reelection chances. Alex M Azar II, the secretary of health and human services and Hahn’s direct superior, has also questioned Hahn’s motives in some conversations with the White House, according to multiple officials.

A senior administration official, who spoke on condition of anonymity, denied that Hahn and Meadows were deeply at odds over the vaccine guidance, saying “the two have a good relationship.” Meadows’ only concern was that changing the guidance in the middle of ongoing clinical trials could confuse vaccine makers, said the official, who noted that the White House eventually approved it.

Alyssa Farah, the White House communications director, said, “The White House has always encouraged the FDA to follow the science and their expert medical viewpoints while also encouraging the FDA to work around the clock to help advance therapeutics and ultimately a vaccine that will save American lives.” An FDA spokesman also said that the White House and the Department of Health and Human Services “continue to support the science-based decisions of the agency’s career professionals.”

In what might be the final months of the Trump administration, and close enough to the election to make his firing unlikely, Hahn seems to be trying to save the FDA from the fate of its sister agency, the Centers for Disease Control and Prevention, whose scientists have been stripped of much of their authority and independence in responding to the pandemic.

“It’s better late than never, but I do think we can see a lot of damage has been done,” said Dr Jesse L Goodman, the FDA’s chief scientist from 2009 to 2014. “And I don’t think they are out of the woods yet.”

To many FDA scientists, Hahn, an oncologist and former hospital administrator with no experience in Washington, has been a disappointing leader for much of his 10-month tenure. Under his leadership, the FDA authorised hydroxychloroquine for hospitalised COVID-19 patients despite a lack of evidence, only to reverse the decision once the drug was tied to severe side effects.

In late August, on the eve of the Republican convention, Hahn made a significant error at a news conference with the president announcing the approval of plasma treatments for COVID-19. The commissioner greatly exaggerated the benefits of the treatment, angering the scientific community. He publicly corrected the record.

“I think that was really a wake-up call about the legacy of his leadership,” said Goodman, now a professor of medicine and infectious diseases at Georgetown University.

Indeed, the plasma debacle seems to have been a turning point for Hahn and agency scientists dismayed by the White House’s efforts to influence the FDA’s actions. Within days, Hahn demoted the new FDA spokeswoman, Emily Miller, who had arranged the White House appearance and also ousted John E (Wolf) Wagner, who had been installed by White House appointees to run the agency’s communications shop.

On Sept 10, eight high-level directors at the FDA took the unusual step of writing a joint statement, published in USA Today, warning that real or perceived political interference could destroy the agency’s credibility with the public. Hahn tweeted his support of the statement and later that day noted that new vaccine guidelines were coming.

Some regulators at the FDA were worried about companies rushing early trial data to the agency before enough had been collected to make sound judgments about safety and efficacy. Pfizer’s chief executive, Dr Albert Bourla, had repeatedly dangled the prospect of an early readout of Pfizer’s trial data by late October.

A growing number of pharmaceutical companies and medical groups were also privately appealing to FDA regulators to give more clarity about what it would take to earn an emergency authorisation. The criteria for such authorisations are vague, essentially just calling for potential benefits to outweigh the risks.

In early September, a small team of experts in the FDA’s Office of Vaccines Research and Review drafted new guidelines, to make its standards unmistakable to drugmakers and reassure jittery Americans that the agency would not cut corners when assessing a vaccine’s safety and effectiveness, including after granting an emergency authorisation.

Within days of submitting the guidelines to the White House, FDA scientists began to fear they would never be made public — Trump attacked them in a news briefing — and began discussing how to get them out. They settled on an idea that would most likely draw less attention: including them in the briefing materials for an outside group of vaccine experts scheduled to meet Oct 22.

The manoeuvre was unusual: Briefing materials for outside advisory groups are typically posted just a few days ahead of the meeting. FDA regulators had expected to provide the guidelines there well after they had been cleared by the White House. But as West Wing officials stalled, agency scientists began to discuss using the upcoming meeting to their advantage.

They slipped a condensed version of the guidelines into the appendix of the committee’s briefing materials, with reordered paragraphs and a new title, describing it as a summary of advice already given to companies. Dr Peter Marks, the agency’s top regulator for vaccines, has called the recommendations “aspirational” in what some saw as a deliberate effort to downplay their importance to those officials who might obstruct them.

Privately, some White House officials argued that the pharmaceutical industry was not in favour of the guidelines. But in fact, executives from Johnson & Johnson and Merck, each with vaccine candidates, called for their release. The biotech industry’s trade organisation wrote a public letter to the Department of Health and Human Services asking Azar to quickly publish the guidelines and make them available to the public, and Oct 6, Bourla, Pfizer’s top executive, wrote on Twitter that he had faith in the FDA’s ability to set standards.

The same morning, the FDA’s briefing materials were quietly posted online. The White House was given only about an hour’s notice, according to a senior administration official. Later that day, the White House surprised top FDA officials and abruptly cleared the guidelines, which were then posted to the FDA website.

Scientists at the Food and Drug Administration celebrated on video calls. It was a win for career civil servants — and for the pharmaceutical industry, which played an important part in helping the agency get the guidelines cleared, some experts said.

The commissioner’s office has been rampant with rumours that Hahn will be fired, according to three senior administration officials. Although some consider it highly unlikely the president would risk the negative press from such a move, others aren’t so sure.

“The usual rules don’t apply to this administration,” said Coleen Klasmeier, a former FDA lawyer who is now a partner at Sidley Austin. “My conclusion is nobody is particularly safe, even now.”

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