Washington, DC, August 25, 2020 United States Senator Elizabeth Warren (D-Mass.), Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and Senator Edward J. Markey are requesting copies of all communications between the Food and Drug Administration (FDA) and White House officials regarding the agency’s announcement earlier this week of an Emergency Use Authorization (EUA). Reports suggest that the FDA granted the EUA amid intense political pressure from President Trump and other administration officials, despite limited evidence of convalescent plasma’s effectiveness as a COVID-19 treatment.

Text of letter to FDA (PDF)

In their letter to FDA Commissioner Dr. Stephen Hahn, the lawmakers wrote that it is “critical that the FDA’s drug approval process-which serves as the gold standard around the world-is guided by science, not partisan or political whims.” Protecting the integrity of the FDA’s approval process is even more critical given that the agency will soon be asked to approve one or more vaccines under intense political pressure, and because of its recent decision to issue and then revoke a rushed EUA for hydroxychloroquine for COVID-19 treatment. 

Dr. Peter Navarro, a key White House official, reportedly accused FDA scientists of serving the “Deep State,” by failing to rapidly approve COVID-19 vaccines and therapeutics. President Trump accused FDA officials of “slow-walking the therapy to harm his reelection chances.” But just last week, citing limited evidence of plasma’s effectiveness as a COVID-19 treatment, top government scientists, including Dr. Anthony Fauci and Dr. Francis Collins, urged the FDA to refrain from issuing an EUA for a plasma treatment without more convincing effectiveness data. 

Despite these warnings from public health experts, the FDA issued an EUA for convalescent plasma as a COVID-19 treatment on August 23, touting it as “another achievement in (the) Administration’s fight against the pandemic.” But after the FDA issued its EUA, public health officials expressed concerns that “the scientific integrity of FDA may be significantly compromised” and that “science lost” while “politics won.” Though plasma will not harm patients, there is not scientific consensus on how to interpret existing data on plasma’s efficacy as a COVID-19 treatment. One study, released on August 13th, found that plasma treatment could reduce COVID-19 mortality – but that study was not peer reviewed and did not have a control group, making it hard to determine whether the treatment actually made a difference in patients’ outcomes. 

To better understand the FDA’s decision to issue an EUA for convalescent blood plasma to treat COVID-19, as well as to help determine whether the decision was politically motivated, the lawmakers requested copies of all emails and other written communications between FDA officials and White House officials containing the words “COVID-19” and “convalescent plasma” sent between January 1, 2020 and August 24, 2020. The lawmakers also requested descriptions of any and all phone calls, meetings, and other verbal communications at which FDA Commissioner Dr. Stephen Hahn, or other senior FDA officials, and White House officials were present that took place between January 1, 2020 and August 24, 2020 and a detailed timeline of the EUA approval process for convalescent plasma.