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Trump HHS advisor pressured FDA, says House subcommittee

Posted 09 February 2021 | By Michael Mezher 

Trump HHS advisor pressured FDA, says House subcommittee

The House Select Subcommittee on the Coronavirus Crisis on Monday released nearly 100 pages of emails underscoring political pressure from a Trump administration official who pushed for the authorization of hydroxychloroquine and convalescent plasma to treat COVID-19.
Citing the emails, Subcommittee Chairman James Clyburn (D-SC) wrote to White House Chief of Staff Ronald Klain and Acting Health and Human Services Secretary Norris Cochran seeking additional documents and communications relating to the Trump administration’s COVID-19 response.
Several of the emails from Paul Alexander, who worked as a senior advisor to then-Department of Health and Human Services (HHS) Assistant Secretary for Public Affairs Michael Caputo, were sent to former FDA Commissioner Stephen Hahn and Anand Shah, who was FDA’s deputy commissioner for medical and scientific affairs at the time.
In September, shortly after Politico reported on some of Alexander’s emails, HHS announced that Alexander would be leaving the department and that Caputo would be taking a 60-day leave of absence “to focus on his health and the well-being of his family.”
In one set of emails sent in July, after FDA had already rescinded its emergency use authorization (EUA) for hydroxychloroquine, Alexander sent Hahn and Shah an embargoed review that would later be published in The BMJ to “draw your attention” to a low-certainty finding that hydroxychloroquine led to “shorter symptom duration than standard care.” (RELATED: FDA revokes EUA for hydroxychloroquine, chloroquine, Regulatory Focus 15 June 2020).
“I share this submission (embargoed) so highly confidentially, please share with no one not even in people who work or report to you … This is for your eyes only but can inform your decision-making behind the scenes as it will be in print maybe one week,” Alexander wrote. The paper, published in late July, would actually say, “There was no evidence that remdesivir (moderate certainty), hydroxychloroquine (low certainty), and lopinavir-ritonavir (low certainty) led to shorter symptom duration than in patients who received standard care.”
Similarly, in August, just days before FDA would issue and EUA for convalescent plasma, Alexander emailed Hahn and Shah a summary of mostly observational and a couple randomized controlled trials (RCTs) involving convalescent plasma. (RELATED: Lawmakers, experts raise questions after convalescent plasma EUA, Regulatory Focus 25 August 2020).
“I share this to help give us cover in our decisions. It to me is well-positioned. My view is that [convalescent plasma] CP should be used and is showing to be safe, and an EUA as an example, if one is ever contemplated, is well credible and has merit. [National Institutes of Health] NIH has stepped out of their lane based on what I am reading now and I will tell you this, that nonrandomized evidence will shortly be mainstreamed alongside RCT evidence once it is high quality evidence,” Alexander wrote. (RELATED: FDA narrows convalescent plasma EUA, Regulatory Focus 5 February 2021)
“Three days later … FDA granted an EUA for convalescent plasma. Commissioner Hahn was later forced to apologize and the FDA’s chief spokesperson was removed after it became clear that Dr. Hahn, along with President Trump and Secretary Azar, cited grossly inaccurate statistics on the effectiveness of convalescent plasma at a press conference,” Clyburn wrote in his letter to Cochran.
In another email sent to NIH officials, Alexander argued that, “Convalescent plasma is potentially useful now as we await more evidence” and pushed for the agency to be more open to nonrandomized evidence in support of convalescent plasma. “All this to say that if the NIH’s position is that RCT evidence is your standard, then this must change,” Alexander wrote.
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