What was going through the minds of the FDA officials during the earliest days of the COVID-19 pandemic? Thanks to hundreds of emails released by the FDA on Thursday—forced through the Freedom of Information Act—enquiring minds can find out.
It's still just a glimpse, however, as quite a bit of the text copy, subject lines and emails are blacked out for confidentially reasons.
Still, the familiar cast of task force and government agency officials from that time—Deborah Birx, Stephen Hahn, Anthony Fauci, Robert Redfield, Brett Giroir and many White House handlers from the president's and vice president's office—appear often in the pages and pages of emails.
Pharma executives also make occasional appearances in the cache of emails on issues such as press release sign-offs, testing and offers for experimental drugs.
For instance, on March 31, Gilead CEO Daniel O’Day wrote to then-FDA Commissioner Hahn with a draft of the pharma company’s press release about donations of remdisivir. He noted the release was also shared with the review team at the FDA as well as the White House—and gave his personal cell phone number (blacked out now) in case they had wanted to discuss further.
The draft press release is attached, but blacked out. While the press release doesn’t seem to have made it out of draft, on April 4, O’Day published an open letter on the Gilead website announcing it was expanding access to remedisivir allowing physicians and hospitals to apply for emergency use.
As also might be expected, there were many queries and suggestions and ideas around testing unproven treatments during those early days of the pandemic.
The malaria drug hydroxychloroquine dominated headlines early in the pandemic, and in one of the emails, Mylan’s Anil Soni, head of global infectious diseases, offered quick supplies of the medicine by leveraging "existing contractual relationships” to move as quickly as possible.
Like Soni’s message, dozens more of the emails released also discuss hydroxychloroquine, which President Trump often touted in news briefings. Fox News talk show host Laura Ingraham wrote to Molly Michael, an executive assistant to the president, in early April, forwarding an email she had received from celebrity dermatologist Nicholas Perricone questioning a New York trial of the drug.
Abbott’s head of diagnostics Andrea Wainer wrote to the FDA group several times. In one April email she offered a testing supply outlook, noting it was in addition to Abbott’s “daily shipment and testing report.”
In May, Merck & Co.’s head of research Roger Perlmutter sent a proposal for a “comprehensive approach to address the needs for enhanced biological manufacturing capabilities in the U.S.” to the White House, which was passed on to the FDA.
And while the world likely won’t ever find out what advice the FDA gave, Hahn, the FDA chief of staff and a senior advisor were pressed by Trump’s top domestic policy adviser Joe Grogan at 1:30 p.m. on April 21: “Guys, in the next 45 minutes, can you get me more than what I have below? For POTUS to say.”
At 2:30 p.m. Hahn wrote to his team: “Some edits. Will forward to Joe.”
During the White House press conference later that day, Trump announced among other items that the FDA had authorized more than 50 diagnostic tests, along with antibody tests to help find sources of convalescent plasma and the first take-home test.