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0514 FOIA dump
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Politics, Policy & Law

FDA documents shed light on chaotic COVID decision-making during Trump administration

Internal FDA documents suggest the need for clearer lines of authority to manage emergency response

May 15, 2021 | 12:42 AM GMT

Internal FDA and White House communications released by FDA in response to a Freedom of Information Act request provide a glimpse into the in-fighting, leaking and chaotic decision-making during some of the most fraught moments of the pandemic during the Trump administration.

The documents feature the controversies over emergency use authorizations (EUAs) for convalescent plasma and hydroxychloroquine, highlighting the role of the White House, celebrities, and disputes within the administration in making decisions that were at the heart of the U.S. response to the pandemic. 

One set of emails demonstrates that then-FDA Commissioner Stephen Hahn first misunderstood the data about the efficacy of convalescent plasma and then misled the public about his role in exaggerating the treatment’s benefits. Other emails show that television personalities promoting hydroxychloroquine had direct access to top FDA and White House officials. In addition, they point to a rift with NIH, with FDA officials believing leaks from NIH were undermining its authority. 

The document dump comes at a time when FDA has moved on from the Trump era but remains in a state of flux, lacking a Senate-confirmed Commissioner and with a number of senior positions being filled on an acting basis.

Oversight over COVID-19 countermeasures and restoring operations that were disrupted by the pandemic is FDA’s main focus. 

Acting FDA Commissioner Janet Woodcock is continuing to devote some of her time to the Biden administration’s initiative to develop COVID-19 countermeasures, she said this week in remarks to the Reagan-Udall Foundation for the FDA.

Rebuilding agency morale is one of her top priorities, Woodcock said.

FDA has drafted and soon will release a lengthy “lessons-learned” report about its COVID-19 experience, Woodcock said.

The emails and memos released this week suggest that some of the lessons should go beyond scientific and regulatory issues, and should include communications and the establishment of clear lines of authority among HHS agencies and between FDA and the White House. They also reinforce the wisdom of nominating a permanent Commissioner who has a firm understanding of medical product development, regulatory issues, as well as knowledge of the political process. An overriding lesson from the Trump administration is the importance of maintaining the agency’s independence from political influences over regulatory decisions. 

The emails reveal that FDA believed NIH had encroached on its regulatory authority, and that  the White House, NIH and HHS had leaked information to the press that interfered with FDA’s oversight of pandemic countermeasures.

Hahn misled the public

While most of the content from the emails, including discussions of draft press releases and media talking points, is redacted, FDA released two sentences from an email that shed light on a low point in Hahn’s tenure.

On the afternoon of Sunday, Aug. 23, 2020, Hahn wrote: “Yes, you are absolutely right. I like 35% increase in survival.”

The FDA Commissioner was referring to a suggestion that he assert that convalescent plasma produced a dramatic survival benefit in COVID-19 patients. It isn’t clear who suggested that he endorse the 35% survival benefit, a figure that was at odds with the available data and stemmed from a confusion between absolute and relative risk. 

The email was sent to Anand Shah, deputy commissioner for medical and scientific affairs, Emily Miller, acting assistant commissioner for media affairs, and Kevin Bugin, director for special programs at the Office of New Drugs in the Center for Drug Evaluation and Research.

The same evening, Hahn stood next to then-President Donald Trump at the White House to announce the convalescent plasma emergency use authorization (EUA). “We dream in drug development of something like a 35% mortality reduction,” Hahn said. “This is a major advance in the treatment of patients.” He added: “A 35% improvement in survival is a pretty substantial clinical benefit. What that means is — and if the data continue to pan out — of 100 people who are sick with COVID-19, 35 would have been saved because of the admission of plasma."

An FDA press release about the convalescent plasma EUA quoted HHS Secretary Alex Azar calling the authorization “a milestone achievement in Trump’s efforts to save lives from COVID-19.”

Hahn immediately came under attack from scientists who pointed out that there was no basis for his survival benefit claims. Eric Topol, founder and director of the Scripps Research Translational Institute, called for Hahn to resign, as did former CMS Administrator Andy Slavitt.

Hahn corrected his statement, asserting in tweets on Aug. 24 and media appearances in the following days that he had accidentally misspoken, that he had inadvertently mixed up relative and absolute risks, and that he hadn’t intended to tell the American public that convalescent plasma reduced the mortality of COVID-19 by 35%.

Hahn’s email, however, demonstrates that, contrary to his apologies and corrections, he had planned the remarks in advance, and that no one in his entourage had discovered the error. 

The incident prompted Hahn to distance himself from the White House and to remove Miller from her position as head of the agency’s press operations.

After the convalescent plasma incident, Hahn started a series of meetings with an informal group of advisers to help him develop policies. The meetings were not revealed to the White House and were not listed on Hahn’s official calendar. Participants included scientists who were advising the Biden presidential campaign, including Topol and Michael Osterholm, director of the Center for Infectious Disease Research and Prevention at the University of Minnesota. Margaret Hamburg, who served as FDA Commissioner in the Obama administration, was also a member of Hahn’s kitchen cabinet.

The documents released by FDA show that Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, was fully in support of the convalescent plasma EUA.

They also confirm media leaks at the time that said that issuance of the EUA was delayed for a week because of leaked objections from NIH Director Francis Collins, who felt the data were too weak to support an EUA, and that Marks and other senior FDA officials were exasperated by the leaks. 

On Aug. 18, 2020, Marks wrote to Hahn stating that he was “greatly troubled and saddened by the fact that someone keeps taking it upon themselves to leak confidential conversations regarding our regulatory deliberations. That said – knowing this likely would happen is why we could certainly not proceed with a regulatory action last week after Dr. Collins remark.”

Marks wrote that news of Collins’ opposition to granting the convalescent plasma EUA was “yet another leak from a meeting that should have been a confidential one, and could undermine the type of open dialogue that would optimally take place.”

A March 2021 decision by NIH to halt a trial of convalescent plasma because it failed to benefit emergency department patients who developed mild-to-moderate symptoms of COVID-19, and a series of studies that have failed to demonstrate benefit from the treatment in other settings, have led to calls for FDA to rescind the EUA.

Celebrities pushed for hydroxychloroquine

The FDA documents shed light on another COVID controversy, the EUA that was granted for hydroxychloroquine.

Celebrity physician Mehmet Oz and conservative pundit Laura Ingraham promoted the malaria drug to White House officials, including Deborah Birx, who served in the Trump administration as the White House Coronavirus Response Coordinator.

On April 7, Ingraham wrote to a White House official forwarding complaints from a “world-famous dermatologist, best-selling author” that trials of hydroxychloroquine were using vitamin C as a placebo. The email asserted that “of course it is an active antiviral agent. This can’t be an oversight so I have to assume they are trying to make hydroxychloroquine look in effective [sic] when compared to a placebo.” Ingraham demanded that Trump be informed of the complaints.

Ingraham sent the email three days after she had met in the White House with Trump and Hahn to push for authorization of hydroxychloroquine.

The documents also include an email to FDA from Trump adviser Hope Hicks regarding a nutritional supplement that has been marketed as a COVID-19 prophylactic.  

The COVID documents are available online

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