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July 7, 2021

FDA Communications with White House Officials Involved in Federal Covid-19 Response

Records released by the U.S. Food and Drug Administration in response to American Oversight’s request for all email communications between agency and White House officials involved in the federal government’s response to the coronavirus outbreak. These records include communications and calendar entries reflecting contact between FDA and White House officials from March to April 2020.

Statusactive

Records released by the U.S. Food and Drug Administration in response to American Oversight’s request for all email communications between agency and White House officials involved in the federal government’s response to the coronavirus outbreak. These records include communications and calendar entries reflecting contact between FDA and White House officials from March to April 2020. Details on the content of these records are below.

In the Documents

Communications with Federal Officials and Private Companies

March 2, 2020: James Williams, special assistant to the president, sent Stephen Hahn, the commissioner of the Food and Drug Administration, a document from Beyond Air. Williams wrote that the company was producing a portable Nitric Oxide system and asked if their product could be “prioritized for consideration of approved testing and an open label trial with Covid-19 infected patients.” Hahn replied, “We will look at it.” 

Joe Grogan, the director of the United States Domestic Policy Council, replied, “James give them whatever they need. This company comes highly recommended … they aren’t kooks.” Hahn wrote back, “We’re on it.”

March 22, 2020: Drew Horn, senior adviser to the director of national intelligence, forwarded White House Coronavirus Task Force Coordinator Deborah Birx an email from Vinh Vuong, the chairman of Vuong Enterprises. Vuong wrote that a California-based company called DiaCarta had developed a very effective coronavirus test, which he emphasized was made in the U.S. Birx forwarded the message to Hahn, whose response has been redacted.

March 24, 2020: Grogan sent Hahn an email, the content of which has been completely redacted. Hahn replied, “We’ll work on this.”

March 30, 2020: Tyler Ann McGuffee, associate adviser to Vice President Mike Pence, forwarded Hahn and Birx a message from Thomas Cahill, the managing partner of investment firm Newpath Partners. Cahill wrote that his “team of citizen-scientists” had developed a proposal that would “provide a safe and effective therapy for Covid-19 within as little as 3 months.” Hahn replied, “Yes, I do think we (FDA) should engage.” 

April 4, 2020: Grogan sent an email with the subject line, “Tammy Beckham????,” referring to the HHS director of infectious disease and HIV/AIDS policy. Though Grogan’s initial email is redacted, he later emailed Hahn asking, “Steve can you do a friendly check in buddy buddy with [Assistant HHS Secretary Brett] Giroir and find out what these guys are doing?” Hahn replied, “I definitely know who this is. I’ll check with Brett.” Grogan said, “Thanks. There have been document leaks out of that shop too.”

April 7, 2020: Birx had a call with Oracle CEO Safra Catz to “walk through the application [they had] built to assist with Covid-19” and to explain how “it can help augment clinical trials and other efforts currently underway.” 

April 9, 2020: In an email to McGuffee and another White House official, Oracle Vice President Josh Pitcock wrote, “Since Safra and Dr. Birx spoke we have updated the TLS [Therapeutic Learning System] and it is now capable of taking in the testing results. … So, great progress for what Dr. Birx was hoping TLS could do.” Later that day, Birx said in an email to McGuffee and Hahn, “I didn’t ask them to do this – I only listened to her and did NOT commit to anything nor did I say this was a good idea.” 

April 21, 2020: Katie Miller, then Pence’s press secretary, forwarded Hahn information that presidential adviser Hope Hicks had received from a California doctor Hicks said she knew about Cell Armour. According to the doctor’s initial email, the product was “demonstrating notable efficacy against” Covid-19 and had a “strong potential to change the trajectory of the COVID-19 pandemic.” Miller wrote, “Can you please check into the below.” Hahn replied, “Will do.” 

Communications About Hydroxychloroquine

March 22, 2020: Birx emailed Hahn about a request from Dr. Mehmet Oz, who asked that the federal government provide him with anti-malaria drug hydroxychloroquine for use in a trial testing its efficacy as a coronavirus treatment. Hahn wrote back, “I have lots of data on this,” and he and Birx set up a call to talk further. 

March 23, 2020: Grogan sent FDA Associate Commissioner Laura Caliguiri an email with the subject line, “chloroquine updates,” and said, “to the info you are sharing, can you please add a daily update [redacted].”

March 28, 2020: Oz asked Birx for information about a hydroxychloroquine trial in New York state. He wrote that he was being asked about the trial in interviews, but no one at the governor’s office was able to provide him with information. Birx forwarded the message to Hahn, writing, “We should talk.” Hahn replied, “Call me when you are free?”

April 7, 2020: Fox News anchor Laura Ingraham wrote to White House Associate Director Molly Michael, with questions about the hydroxychloroquine trial taking place in New York. She wrote, “Please tell POTUS this is worth a call from someone in his staff to New York’s Health Commissioner Mr. Zucker.”

Hahn forwarded the message to Grogan and said that Ingraham’s facts about the New York trial were incorrect. Grogran replied, “sheesh.”

April 20, 2020: Miller forwarded Hahn an email from Hicks: “Cuomo said today, over 20 hospitals conducted hydroxychloroquine trials, report of results will go to the FDA and CDC today.” Hahn replied, “Let’s talk.”

April 21, 2020: Miller sent Hahn an article titled “More deaths, no benefit from malaria drug in VA virus study.”