“In my career I have been a doctor and a researcher foremost and it is an honor to join Flagship Pioneering in its efforts to prioritize innovation,” Hahn said in a statement. The Washington Post first reported that Hahn was in talks to join the company.
Flagship and Moderna, which are headquartered near each other in Cambridge, Mass., continue to share ties. Flagship CEO Noubar Afeyan serves as chairman of Moderna; Stéphane Bancel, Moderna’s CEO, serves as a Flagship special partner. Flagship also holds 20 million shares of Moderna stock, which are currently valued at more than $4 billion after the vaccine-maker’s stock price soared during the pandemic; it sold $1.4 billion worth of Moderna shares earlier this year, senior partner Christine Heenan confirmed. Moderna had never turned a profit before the pandemic.
Hahn, a longtime cancer doctor who headed the FDA when it authorized Moderna’s vaccine last year before stepping down at the end of the Trump administration, will start at Flagship on Wednesday, the company said.
There are no rules barring Hahn from taking a role with Flagship, and other FDA officials have taken prominent positions in biotechnology after leaving government service. Scott Gottlieb, who preceded Hahn as FDA commissioner during the Trump administration, joined the board of pharmaceutical giant Pfizer after stepping down from government in 2019. Amy Abernethy, who was the FDA’s top career official under Hahn, this month was hired by Verily, the Google spinoff focused on health-care innovation — the same firm where former FDA commissioner Robert Califf serves as an adviser.
Ethics experts said that Hahn would be limited in communicating with the FDA, including a lifetime ban on particular matters that he worked on and a one-year ban on communicating with the FDA about any matters on behalf of his new employer.
The Office of Government Ethics referred questions to a 2016 legal advisory that would permit Hahn to provide “behind-the-scenes” assistance to Flagship, like giving advice or drafting documents.
But watchdogs raised concerns regardless.
“Is it concerning whenever a high-level government official who was instrumental in actions that may have profited a company turns around and goes to work for that company soon thereafter? You bet it is,” said Walter Shaub, a senior ethics fellow at the Project On Government Oversight and the former director of the Office of Government Ethics. “This is one of many gaps in our weak ethics laws.”
Jeff Hauser, director of the Revolving Door Project at the Center for Economic and Policy Research, said he was specifically concerned that Hahn would take a role with Moderna’s key backer, citing conspiracy theories promulgated by anti-vaccination groups about pharmaceutical companies profiting from the pandemic.
“You want to avoid even the suggestion of a financial payoff for vaccine approval,” Hauser added, saying that the perception of the “FDA needs to be holier-than-thou … There should not be any appearance of any conflict.”
Hahn, who was confirmed by the Senate as FDA commissioner in December 2019, withstood White House pressure to rush authorization of the vaccines before Election Day, backing career officials who set tougher standards to boost transparency and public trust in them. More than 70 million Americans have since received Moderna’s two-dose mRNA vaccine, according to data compiled by the Centers for Disease Control and Prevention.
Moderna reported $1.2 billion in profits in the first quarter of 2021, driven by $1.7 billion in coronavirus vaccine sales, compared to a loss of $124 million in the first quarter of 2020. The 11-year-old company also received $955 million in contracts with the U.S. government to develop the coronavirus vaccine as part of last year’s Operation Warp Speed push.
Meanwhile, Flagship on Monday announced that it had raised an additional $2.2 billion, as it prepares to launch a new “preemptive medicine and health security” division dedicated to preventing the onset of diseases like cancer, as well as future pandemic threats. Hahn will serve as the division’s chief medical officer.
“There is no better example of the power of bioplatform companies than Flagship-founded Moderna, which was able to rapidly shift its focus in 2020 to develop, test, and deploy its covid-19 vaccine in record time,” Afeyan said in a statement, announcing the additional funding.