Records Show Frustration at FDA as Agency Prepared to Authorize Convalescent Plasma Treatment
American Oversight has obtained records from the summer of 2020 in which FDA officials expressed frustration with scientists at the NIH days before the planned authorization of convalescent plasma as a Covid-19 treatment, a decision heavily promoted by Trump.
On Aug. 23, 2020, the Food and Drug Administration granted emergency use authorization (EUA) to convalescent plasma as a Covid-19 treatment, just one day after then-President Donald Trump claimed that the “deep state” at the FDA was willfully delaying the approval of coronavirus therapeutics. Trump had frequently extolled the treatment’s efficacy, and when announcing the new authorization, FDA Commissioner Stephen Hahn followed Trump’s lead, incorrectly stating that convalescent plasma would save 35 percent of Covid-19 patients who got the treatment. Hahn later apologized for the over-representation.
American Oversight recently obtained communications of FDA officials and political appointees from the days before convalescent plasma was authorized for Covid-19 patients. The emails, also reported on by Politico, offer an inside look into the federal government’s internal disagreements surrounding the authorization.
The records illustrate the White House’s keen interest in the decision to authorize convalescent plasma. On Aug. 17, 2020, FDA Chief of Staff Keagan Lenihan told Health and Human Services Secretary Alex Azar: “To clarify, we had multiple conversations with NIH, Dr. [Deborah] Birx, and Paul [Mango, HHS deputy chief of staff] about moving forward with an EUA. It is my understanding the Commissioner spoke with both the VPs office and [White House Chief of Staff] Meadows office to read them in on the plan.”
FDA officials’ frustration with other science agencies over the delay in authorization is also apparent in the communications. On Aug. 18, FDA Media Relations Director Stephanie Caccomo sent top officials, including Hahn, Lenihan, and Peter Marks, the director of the FDA’s Center for Biological Evaluation and Research, a message from New York Times reporter Noah Weiland. Weiland wrote that the Times was planning to run a story about how National Institutes of Health Director Francis Collins and Dr. Anthony Fauci had cautioned against authorizing plasma treatment, due to concerns that the current data from the Mayo Clinic was too weak.
In an email also reported on by Politico, Marks replied to Caccomo, indicating his displeasure: “There is a much more disturbing aspect to me about this, aside from the fact that it is FDA and not NIH that determines whether or not something meets the standard for EUA: this was yet another leak of information from a meeting that should have been a confidential one, and could undermine the type of open dialogue that would optimally take place.” He also sent an email just to Hahn and Lenihan, saying that “knowing that this likely would happen is why we could certainly not proceed with a regulatory action last week after Dr. Collins remark.” (It is not clear what remark Marks is referring to.)
In the Times article, which was published the next day, NIH official H. Clifford Lane said that the authorization was on hold, a statement that appears to have angered officials at the FDA. Following publication, Caccomo sent an email pointing out that Lane was the on-the-record source. Marks responded, “I would like to at least touch upon this at our meeting today.” Hahn agreed.
But FDA officials seemed determined to push on with the EUA. In partnership with the Mayo Clinic, the FDA had started an Expanded Access Program (EAP) in April to allow patients with Covid-19 to access convalescent plasma outside of clinical trials. On Aug. 19, Marks wrote: “FDA continues to get data regarding the EAP, since it is an ongoing program, and since there are many analyses ongoing. … We do not intend to change the outcome of anything based on these data. There will be confirmatory data from the Mayo, which we will have shortly that should also not change anything in the wording of the EUA.”
On Aug. 22, the day before the authorization, Marks emailed to say that “the dataset that came in from the Mayo is smaller than we would have liked,” but affirmed that the decision to authorize remained unchanged.
In January 2021, a study conducted by researchers at Oxford University found that “there has been no convincing evidence of the effect of convalescent plasma on clinical outcomes in patients admitted to hospital with Covid-19.” On February 4, the FDA narrowed the EUA to recommend the use of convalescent plasma only in specific circumstances.
According to the records, Hahn also became frustrated with Emily Miller, the agency’s chief spokesperson and a former reporter for the right-wing One America News Network. Miller’s appointment that month by the White House to a role not traditionally filled by a political appointee had drawn significant criticism.
On Aug. 21, Hahn sent Miller an email with the subject line, “Response on NYT/Plasma EUA Statement,” and asked, “Have you reviewed.”
Associate Commissioner John Wagner replied, “I don’t think she’s up on comms yet – picking up today.”
“What does that mean?” Hahn replied. “[S]he needs to be in charge of OMA [Office of Media Affairs] starting today. That is her job and we need her to move things forward.” Miller was fired a week later.
To learn more about the Trump administration’s promotion of certain treatments during the pandemic, visit our Covid-19 Oversight Hub.