Six months after his agency cleared Moderna’s coronavirus vaccine for emergency use, the former head of the Food and Drug Administration is joining the venture capital giant that created the Cambridge biotech.
Dr. Stephen Hahn, who served as FDA commissioner during the last 13 months of the Trump administration, will start working Wednesday as chief medical officer of Flagship Pioneering, the major venture capital firm also located in Cambridge. Moderna is perhaps the best known of Flagship’s more than 40 companies.
Flagship said Tuesday that Hahn will head an initiative aimed at preventing illness. The effort will include vaccines to protect people from infectious diseases yet to threaten the world and drugs to treat “existing pandemic diseases such as obesity, cancer, and neurodegeneration,” according to Flagship.
“The COVID-19 pandemic brought into stark focus how important it is to bring increased attention and investment to our health security globally, and to preemptive medicine more broadly,” said Noubar Afeyan, the billionaire founder and chief executive of Flagship who also chairs Moderna’s board.
The Washington Post on Monday first reported that Hahn was in talks to join Flagship, and the venture capital firm confirmed his appointment later in the day.
Hahn is a radiation oncologist who served as chief medical executive at the MD Anderson Cancer Center in Houston before his appointment to the FDA. He said the pandemic has underscored how vital it is to invest in preventative medicine.
“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 US and around the world,” he said in a Flagship news release.
No rules prohibit Hahn from joining Flagship, and he isn’t the first former high-ranking FDA official to take a paid position in biopharma after leaving the drug regulating agency.
Dr. Scott Gottlieb, who preceded Hahn as commissioner under Trump, joined the board of New York-based pharmaceutical giant Pfizer after leaving the government in 2019. Pfizer’s COVID-19 vaccine was the first cleared for emergency use by the FDA, on Dec. 11.the sign-off coming a week before Moderna received similar authorization.
Earlier this month, Amy Abernethy stepped down as the FDA’s second-in-command to join Verily, the Google spinoff working on health care innovation. Another former FDA commissioner, Dr. Robert Califf, serves as an adviser to Verily.
Several government watchdog groups criticized the trend on Tuesday, saying the appointment of former high-ranking FDA officials to leadership positions in biopharma erodes confidence in government regulation of the industry.
“Hahn’s joining Flagship Pioneering is just another example of the troubling revolving door between FDA and private industry that has undermined public trust in the agency,” said Dr. Michael A. Carome, director of the health research group at Public Citizen, a Washington nonprofit consumer advocacy organization.
Jeff Hauser, executive director of the Revolving Door Project at the Center for Economic and Policy Research, said he was confident that Hahn acted appropriately when the FDA authorized Moderna’s coronavirus vaccine, which Hauser himself received.
But he said Flagship’s hiring of Hahn could fuel conspiracy theories that the FDA cleared the messenger RNA vaccine in a quid pro quo. Hauser was also concerned that Hahn’s insights as the former head of the FDA could give Flagship biotechs an unfair advantage when applying for drug approvals.
“We don’t want people to be able to game the FDA process,” Hauser said.
The Office of Government Ethics issued a legal advisory in 2016 that spells out some limits Hahn will face at Flagship. Those restrictions include a lifetime ban on communicating with the FDA on particular matters that he worked on and a one-year ban on communicating with the FDA on “any matter” on behalf of his new employer.
“Both Flagship and Dr. Hahn are fully aware of the rules and regulations regarding limitations or restrictions on engaging with the FDA or other federal agencies, and will of course comply,” said Christine Heenan, a Flagship spokeswoman.
Flagship has emerged in recent years as one of the richest venture capital firms backing biotech startups. On Monday, it said it has raised $3.4 billion for its seventh fund and has a total of $14.1 billion in assets under management.
Flagship launched Moderna 11 years ago. The biotech’s COVID-19 vaccine is its first product on the market. More than 129 million doses had been administered in the United States as of Monday, according to the Centers for Disease Control and Prevention. Moderna is now one of the most valuable life sciences companies based in Massachusetts, with a market value of more than $80 billion.