Current Edition

Former FDA chief Hahn joins venture firm that launched Moderna

Dive Brief:

  • Stephen Hahn, the former Food and Drug Administration commissioner under President Donald Trump, is joining venture capital firm Flagship Pioneering as its chief medical officer, helping to lead a program focused on preventive medicine and health security.

 

  • Previously a top executive at M.D. Anderson Cancer Center, Hahn headed the FDA during its high-pressure review of COVID-19 drugs and vaccines in 2020, including Gilead’s antiviral treatment Veklury and vaccines from Moderna and Pfizer. The Washington Post first reported he would join Flagship.

 

  • Flagship founded Moderna in 2009 and remains one of its biggest investors, raising questions about Hahn’s appointment. Industry jobs aren’t an uncommon next step for FDA officials, however. Several past FDA commissioners, for example, sit on drugmaker boards, including Scott Gottlieb, who is a director for Pfizer, and Margaret Hamburg, who is on Alnylam Pharmaceuticals’ board.

 

Dive Insight:

Hahn joins Flagship, one of the highest-profile creators of biotech companies, as the venture firm is turning its success with Moderna and other startups into new capital. On Monday, Flagship announced the closing of its seventh fund, which raised a total of $3.4 billion after reopening for new investments in April.

The sum will be sufficient to back between 20 and 25 new companies, around a dozen of which are already being formed, Flagship’s CEO Noubar Afeyan told BioPharma Dive in an interview before Hahn’s appointment.

The Flagship division Hahn now helps to lead will be supported by some of those new funds. Its focus is developing interventions that safeguard and improve health before a person becomes sick. The division is chaired by Ara Darzi, who as health minister in the U.K. government under Prime Minister Gordon Brown published an influential report on improving healthcare quality in the National Health Service.

“The more we can embrace a ‘what if’ approach, the better we can support and protect the health and well-being of people here in the U.S. and around the world,” Hahn said in a statement on his appointment.

An oncologist by training, Hahn was appointed FDA commissioner in December 2019 and quickly found himself in the pressure-cooker environment of the COVID-19 pandemic. The agency granted a controversial emergency clearance to the unproven drug hydroxycholoroquine after Trump pressed the agency to authorize it based on small, uncontrolled studies. Weeks later, the FDA was forced to revoke it after placebo-controlled trials showed it didn’t work to treat COVID-19. Hahn also received considerable criticism following the FDA’s decision to clear convalescent plasma despite weak data supporting its use against the disease.

During Hahn’s tenure, the agency also authorized and then approved Gilead’s coronavirus antiviral Veklury, as well as emergency clearances for vaccines from Pfizer and its partner BioNTech, and Moderna — enormously important decisions that put the FDA’s review work under a microscope.

News of Hahn’s role at Flagship, which holds a 6.1% stake in Moderna, spurred criticism, even from people supportive of the industry. Similar criticism was levied against Gottlieb when he took a directorship at Pfizer.

“I have the highest respect for Flagship and for Dr. Hahn,” Brad Loncar, CEO of Loncar Investments and a well-known biotech investor, tweeted Monday, before Flagship confirmed Hahn’s appointment. “But I have to keep it real. It would not be a good look for our industry if the person who approved the vaccine went to work for an affiliated company.”

Presidential appointees are barred, sometimes permanently, from lobbying the government on issues they worked on while in government. In this role, however, Hahn is not likely to be called on to represent any Flagship-backed companies before the FDA or other regulators.

Hahn’s appointment to Flagship comes weeks after another former top FDA official, Amy Abernethy, took a job at Google’s health spinoff Verily.