Stephen Hahn, MD, who served as commissioner of the U.S. Food and Drug Administration (FDA) from Dec. 17, 2019 through Jan. 20, 2021, has been hired by Flagship Pioneering Co.—the venture capital firm that launched biotechnology Moderna, Inc., maker of the experimental mRNA-1273 COVID-19 biologic currently being distributed in the United States under an emergency use authorization (EUA) granted by the FDA on Dec. 18, 2020.1 2 3
According to Flagship, Dr. Hahn will lead an initiative to help prevent infectious and chronic diseases. This will include financing the development of vaccines and drugs targeting “existing pandemic diseases such as obesity, cancer, and neurodegeneration.”4
Flagship Pioneering, which holds a 6.1 percent financial stake in Moderna, is led by founder and CEO Noubar Afeyan, PhD, who is also chairman of Moderna. “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,” Dr. Afeyan said. “We are delighted that Flagship will benefit from Steve’s clinical and administrative leadership in helping us dimension and pursue our growing number of explorations and companies in this emerging field.”2 5 6
Dr. Hahn, who oversaw the evaluation process that led to EUA approval for Moderna’s mRNA-1273 COVID-19 vaccine, developed in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), began working as Flagship Pioneering’s chief medical officer on June 16, 2021.1 2
Hahn Hiring and “Revolving Door” Between FDA and Industry
The decision by Dr. Hahn to join Flagship Pioneering has raised some concerns within the biotech investment community. Brad Loncar, CEO of Loncar Investments, wrote:
I have the highest respect for Flagship and for Dr. Hahn. 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.5
“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 Michael Carome, MD, director of the health research group at consumer advocacy organization Public Citizen.4
Pharma Companies Filled With Former FDA Heads
But Dr. Hahn’s move to the pharmaceutical industry is not unusual for top officials at FDA. Earlier this month, former principal deputy commissioner of the FDA Amy Abernathy, MD was hired by Alphabet, Inc.’s Verily Life Sciences to be president of their clinical research business. Dr. Abernathy left the FDA in April. She was twice considered to replace former FDA commissioner Scott Gottlieb, MD after he left the agency in 2019 to join the board of directors of pharmaceutical giant Pfizer, Inc.7 8 9
Another former FDA commissioner, Robert Califf, MD, has been serving as a senior adviser to Verily since 2017. Additionally, in 2019, Dr. Califf was hired by Alphabet to serve as head of strategy and policy for Verily and Google Health.4 10 11
“[I]t is an honor to join Flagship Pioneering in its efforts to prioritize innovation, particularly in its Preemptive Medicine and Health Security Initiative,” said Dr. Hahn. “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.”5
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Click here to view References:
1 Diamond D. Trump’s FDA commissioner takes job at Moderna backer. The Washington Post June 14, 2021.
2 LaHucik K. He authorized Moderna’s vaccine 6 months ago. Now, ex-FDA chief Hahn joins biotech’s backer. Fierce Biotech June 14, 2021.
3 Press release. FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine. U.S. Food and Drug Administration Dec. 18, 2020.
4 Gardizy A. Trump’s FDA commissioner joins Flagship, the Cambridge firm that launched Moderna. The Boston Globe June 15, 2021.
5 Gardner J. Former FDA chief Hahn joins venture firm that launched Moderna. BioPharma Dive June 15, 2021.
6 PR Newswire. Dr. Stephen Hahn, 24th US FDA Commissioner and Former Chief Medical Executive at MD Anderson, joins Flagship Pioneering as Chief Medical Officer of Flagship’s Preemptive Medicine and Health Security Initiative. Flagship Pioneering June 14, 2021.
7 Gardner J. Former FDA official Abernethy joins Google health spinoff. BioPharma Dive June 3, 2021.
8 Spinner J. Verily hires former FDA leader to head clinical research platforms. Outsourcing-Pharma.com June 4, 2021.
9 TVR Staff. Former FDA Commissioner Gottlieb Joins Pfizer. The Vaccine Reaction July 10, 2019.
10 Press release. Former FDA Commissioner Robert Califf Will Head Initiatives at Duke, Verily. Duke University School of Medicine May 17, 2017.
11 Cohen JK. Former FDA commissioner to head strategy for Google Health, Verily. Modern Healthcare Sept. 30, 2019.