INFLUNCE NEEDED?
How Gilead, Regeneron and other top biopharmas used political connections to hurry their Covid-19 products
Zachary Brennan
Senior Editor
When the pandemic first hit US shores in early 2020, there was pressure to act quickly, particularly among top biopharma companies like Gilead, Roche and Regeneron. They expeditiously repurposed and developed new Covid-19 treatments, reaping billions along the way.
Thanks to the latest dump of former FDA commissioner Stephen Hahn’s emails and text messages, released via the FDA’s FOIA office, the agency offers a peek behind the curtain on who exactly was reaching out to Hahn and other former Trump political figures, what they were requesting and, thanks to hindsight, how those early efforts paid off.
Building on the trove of FDA and Hahn-related documents released last October, and May 2021, this latest batch of texts and emails reveal the ways in which Gilead, Roche’s Genentech, Regeneron and billionaire pharma entrepreneur Patrick Soon-Shiong sought and obtained the attention of high-ranking FDA officials.
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For instance, about one month before Gilead won its EUA for remdesivir as a treatment for hospitalized patients with Covid-19, Gilead CEO Daniel O’Day sent several urgent emails to both Hahn and Deborah Birx, Trump’s former coronavirus response coordinator, seeking meetings with both of them, outside of the normal meetings with FDA to be expected as part of a drug development program.
And while the urgency of the pandemic meant business was not proceeding normally, it’s still unusual to see a CEO of a major biopharma company requesting a meeting with two top political officials.
The documents unveiled Wednesday do not say whether that meeting happened with O’Day, but in an email to Birx referencing these O’Day emails, Hahn first asked her opinion on the matter, and then after the follow-up email from O’Day, wrote, “I need to talk to you about this.”
Almost exactly a month later, Hahn texted his former chief of staff Keagan Lenihan to say the EUA for remdesivir is ready.
Gilead’s remdesivir, now known commercially as Veklury, pulled in $5.6 billion in sales for 2021.
In another example of biopharma companies acting in an unorthodox way, Genentech SVP Fritz Bittenbender emailed Trump appointee and former director of the domestic policy council Joe Grogan in March 2020 regarding the company’s donations of its potential Covid-19 treatment tocilizumab. The repurposed drug didn’t win an EUA until June 2021.
Meanwhile, from October 2020 through December 2020, Soon-Shiong texted Hahn at least a half dozen times seeking to provide updates (via the San Diego Union-Tribune and other links) on his firm’s Covid-19 vaccine, previously short-listed to be part of Operation Warp Speed but yet to materialize. Hahn responded to the texts but didn’t indicate that he would do anything to help the billionaire.
The FDA’s top spokesperson also offered a rundown of a potential Wall Street Journal article, highlighting the way in which a group of execs reached out on behalf of Regeneron to Tommy Hicks, co-chair of the Republican National Committee, to help the company move some manufacturing to Ireland to free up space for production of its blockbuster monoclonal antibody combo treatment, which is no longer marketed because it doesn’t work against the BA.2 variant.
That article, published by the WSJ in April 2020, explains how 33-year-old physician-turned-venture capitalist, Tom Cahill, briefed Nick Ayers, former VP Mike Pence’s longtime aide, who “said he knew who to call. That evening, March 27, Regeneron received a call from the FDA. They had permission, starting immediately, to shift production to Dublin.”
Regeneron, Gilead and Genentech did not immediately respond to a request for comment on the emails, but this story will be updated if they do.
AUTHOR
Zachary Brennan