House report finds Trump officials sought to influence FDA during COVID pandemic

Regulatory NewsRegulatory News | 25 August 2022 |  By 

Officials in the Trump administration pressured the US Food and Drug Administration (FDA) during the first year of the COVID-19 pandemic to make regulatory decisions that would benefit the White House’s political goals, according to a new report from the House Select Subcommittee on the Coronavirus Crisis.
 
Among the findings in the report are that Trump administration officials pressured the FDA to reauthorize hydroxychloroquine despite lack of efficacy as a COVID-19 treatment, worked with outside groups to generate support for FDA reauthorizing the drug, and attacked federal officials who weren’t in support of hydroxychloroquine. White House officials also potentially influenced the emergency use authorization (EUA) for convalescent plasma and objected to FDA’s guidance on COVID-19 vaccine safety that called for 2 months of surveillance data, which would have put vaccine authorization after the 2020 US presidential election.
 
The Select Subcommittee began publishing the findings of their investigation in June with a report detailing the Trump administration’s support of a discredited herd immunity strategy promoted by Special Advisor to the President Scott Atlas. The authors of the first report concluded the Trump administration’s support of herd immunity led to many preventable illnesses and deaths in the United States during the COVID-19 pandemic.
 
Pressure to reauthorize hydroxychloroquine
 
In March 2020, FDA issued an EUA for the malaria drugs chloroquine and hydroxychloroquine as treatments for COVID-19 based on pre-clinical and anecdotal clinical data, but later revoked the EUA in June of that year following data showing no clinical benefit of chloroquine and hydroxychloroquine for patients hospitalized with COVID-19.
 
However, Peter Navarro, director of the Office of Trade and Manufacturing Policy, continued to put pressure on former FDA Commissioner Stephen Hahn to reauthorize hydroxychloroquine, according to the authors of the report. Hahn noted in an interview with the Select Subcommittee that Navarro disagreed with FDA’s decision and advocated for an outpatient EUA for hydroxychloroquine starting in June or July of 2020.
 
Navarro also worked with Steven Hatfill, an adjunct assistant professor at George Washington University who was also a volunteer for the federal coronavirus response, to fight federal officials and Hahn on reauthorizing hydroxychloroquine, the report said. Hatfill said the hydroxychloroquine issue was a “knife fight” between White House officials and the FDA when describing an upcoming situation to an unnamed outside ally in an email.
 
The two also collaborated with outside groups to reauthorize hydroxychloroquine, in one case drafting an EUA reinstatement petition letter on behalf of Henry Ford Health System “while obscuring the White House’s involvement.” Hatfill and Navarro were also involved in efforts to convince researchers to conduct a study evaluating hydroxychloroquine with the promise of “millions of taxpayer dollars in promised funding,” the report’s authors said.
 
To create outside support for hydroxychloroquine, Navarro and Hatfill engaged “known extremists and prolific conspiracists” and others such as former White House chief strategist Steve Bannon, Jerome Corsi, and the Association of American Physicians and Surgeons, among others.
 
Hatfill did not disclose his affiliation to the White House when generating outside support for hydroxychloroquine, “using third party intermediaries, instructing his allies not to reveal where he worked, and regularly using only his personal email address to communicate about his efforts,” the report stated.
 
Deborah Birx, former White House coronavirus response coordinator, told the Select Subcommittee in June 2022 that various individuals were communicating “dangerous ideas” about hydroxychloroquine on a daily basis to President Trump.  
 
“Dr. Hatfill’s close coordination from inside the White House with a network of conspiracists resulted in the mainstreaming of a baseless theory for why the federal government was not reauthorizing hydroxychloroquine,” the authors of the report wrote.
 
When federal officials and public health officials did not support the reauthorization of hydroxychloroquine, Navarro and Hatfill attacked them and called for them to be investigated and called for National Institute of Allergy and Infectious Diseases (NIAID) director Anthony S. Fauci and Hahn to be fired from their roles in the White House Coronavirus Task Force.
 
“Dr. Hatfill’s reckless attacks against those who opposed his views on hydroxychloroquine went beyond calling for federal investigations. In multiple instances during his White House tenure, Dr. Hatfill told Mr. Navarro and other White House officials that Dr. Fauci, Dr. Hahn, and other public health officials were personally responsible for thousands of coronavirus deaths for their positions on hydroxychloroquine,” the report stated.
 
Pressure to authorize convalescent plasma
 
The Select Subcommittee report also highlighted the attempts by Trump administration officials to influence FDA into issuing an EUA for convalescent plasma as a COVID-19 treatment on their timeline.
 
When FDA decided to gather more data on convalescent plasma around July 2020 after public health officials raised concerns about insufficient efficacy data, the White House “expressed anger at what was perceived to be an unnecessary delay in issuing an EUA,” the report said.
 
President Trump in particular set a deadline for the EUA to line up with the date of the Republican National Convention. FDA issued the EUA for convalescent plasma on 23 August 2020, a day after Trump sent a tweet accusing the agency of being part of the “deep state” and choosing to delay the decision until after the presidential election. In his interview with the Select Subcommittee, Hahn said he called Trump after the tweet and told him FDA was “nearing a decision or had made a decision” on issuing an EUA for convalescent plasma.
 
Hahn attended a press conference the next day promoting the EUA decision where he “grossly misrepresented the efficacy data,” falsely claiming that convalescent plasma improved mortality for 35% of patients with COVID-19. After receiving criticism from public health officials, he issued an apology over Twitter a day later that was “not cleared through the ‘normal channels’ in the Trump Administration” and angered some Trump administration officials.
 
Pressure to authorize COVID vaccines early
 
President Trump publicly acknowledged his desire to see a COVID-19 vaccine made available “before a special date,” apparently referencing the 2020 US presidential election. Hahn told the Select Subcommittee he was also in contact with Trump’s chief of staff Mark Meadows regarding a timeline for authorization of COVID-19 vaccines for emergency use.
 
However, when FDA submitted draft guidance on surveillance data for manufacturers of COVID-19 to the United States Department of Health and Human Services and White House for review and approval, it included a requirement that developers collect at least 2 months of safety data after patients complete the COVID-19 vaccine series. Due to the progression of COVID-19 vaccine development at that point, it was “increasingly evident that a median follow-up duration of 60 days after the primary vaccination series (which consisted of two doses spaced weeks apart for the vaccine candidates then in phase three trials) would result in FDA not authorizing a vaccine until after the presidential election,” the authors of the report noted.
 
Trump administration officials began objecting to the surveillance data, citing concerns about the timeline and “scientific and clinical rationale for the guidance.”
 
“[R]ather than endorsing FDA’s gold-standard review process for ensuring vaccine safety, Trump White House officials blocked FDA from issuing the formal guidance for multiple weeks, resulting in an extended showdown with the agency,” the report stated.
 
FDA eventually responded by quietly releasing an informal set of Vaccines and Related Biological Products Advisory Committee (VRBPAC) briefing materials in early October 2020 without consulting the White House, with the briefing materials including an appendix stating FDA’s requirement for 2 months of vaccine safety data.
 
Trump administration officials continued to criticize FDA over the EUA timeline after Pfizer submitted their data for the Comirnaty vaccine in November 2020. Hahn and Meadows continued to communicate about the progress of the EUA leading up to the VRBPAC advisory committee meeting for Pfizer’s EUA request. Meadows sent several messages to Hahn after the VRBPAC meeting requesting a phone call where Meadows was “very demonstrative” about his desire to see the Pfizer EUA issued and made a comment that Hahn described as “perhaps related to my position” as FDA commissioner.
 
Hahn said in the Select Subcommittee interview that morale “cratered” inside FDA and led to waning confidence in the agency.
 
“The Select Subcommittee’s findings that Trump White House officials deliberately and repeatedly sought to bend FDA’s scientific work on coronavirus treatments and vaccines to the White House’s political will are yet another example of how the prior Administration prioritized politics over public health,” Rep. James Clyburn (D-SC) said in a statement. “As today’s report makes clear, senior Trump Administration officials undermined public health experts because they believed doing so would benefit the former president politically—plotting covertly with known conspiracy theorists to dangerously push a disproven coronavirus treatment, bullying FDA to change its vaccine guidance, and advocating for federal investigations into those who stood in their way.”
 
Report

 

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