US: Top FDA Officials Accepted Jobs With Moderna After Playing Key Roles in the Licensure of COVID-19 Vaccines
A new BMJ investigation reveals a “revolving door” between FDA officials tasked with regulating COVID-19 vaccines and the companies who manufacture them.
Two high-level regulatory officials with the U.S. Food and Drug Administration (FDA) involved in vaccine oversight accepted jobs at Moderna just months after signing off on the licensure of the company’s COVID-19 vaccine, according to a British Medical Journal (BMJ) investigation.
The report by Peter Doshi, associate professor at the University of Maryland School of Pharmacy and senior editor at The BMJ, reveals a long-standing revolving door between the FDA and pharmaceutical companies whose products it regulates and raises questions about the impartiality and independence of top FDA regulators.
Dr. Doran Fink is a “physician/scientist experienced in regulation and clinical development/licensure of vaccines and related biological products” and was deeply involved with vaccine regulation at the FDA for more than 12 years, according to his LinkedIn profile.
According to the BMJ report, Dr. Fink started his FDA career as a clinical reviewer in 2010 and “worked his way up” to Deputy Director of the Division of Vaccines and Related Product Applications within the FDA’s Office of Vaccines Research and Review, where he led a team of medical officers focused on infectious diseases and related biological projects.
During the COVID-19 pandemic, Dr. Fink was a prominent voice on COVID-19 vaccines and which population groups should receive them. He spoke on behalf of the FDA at numerous meetings held by the agency’s vaccine advisors who met to discuss whether to approve COVID-19 vaccines, change their composition, or authorize boosters.
Dr. Fink also presented at meetings held by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices—a group of health experts that develop recommendations on how to use vaccines—as the FDA’s “principal FDA ex officio representative.”
According to the BMJ report and Dr. Fink’s LinkedIn profile, Fink also served on the senior leadership team for COVID-19 vaccine review and policy activities in response to the COVID-19 public health emergency.
As part of his role, he advised vaccine manufacturers on vaccine development throughout the pandemic and coordinated “expedited review of regulatory submissions,” advised U.S. government stakeholders outside the FDA on COVID-19 vaccine science and development, and contributed to FDA guidance on the development, licensure, and emergency use authorization of COVID-19 vaccines.
Most notably, Dr. Fink engaged in a “senior level review” of the FDA’s decision memoranda for emergency use authorization and licensure of COVID-19 vaccines, including Moderna’s.
According to Fink’s LinkedIn profile, he left the FDA in December 2022 and started a job at Moderna as the head of “Translational Medicine and Early Clinical Development, Infectious Diseases” in February 2023.
Dr. Jaya Goswami has a similar history. Dr. Goswami began working as a medical officer at the FDA’s Center for Biologics Evaluation and Research in March 2020 and had “broad oversight over vaccines and biologics clinical development,” according to the BMJ report.
Goswami was responsible for determining whether Moderna’s COVID-19 vaccine clinical data met regulatory standards for approval. Moderna’s SPIKEVAX received FDA approval in January 2022. Goswami’s LinkedIn profile said she left the FDA in June 2022 and began working for Moderna that same month as their director of clinical development in infectious diseases.
At Moderna, Goswami has been involved with the company’s investigational mRNA vaccine against respiratory syncytial virus (mRNA-1345). The company announced in a press release on July 5 that it had submitted marketing authorization applications with the European Union, Switzerland, and Australia, as well as a “rolling submission of a Biologics License Application” to the FDA—which will be reviewed by the department within the FDA that employed Drs. Fink and Goswami.
According to Moderna, the company made $18.5 billion in 2021 from sales of its COVID-19 vaccine, more than $19 billion in 2022, and projects sales of its COVID-19 vaccine will reach at least $6 billion in 2023.
Dr. Doshi, writing for The BMJ, warns that this is another sign of the “revolving door” between pharmaceutical companies and the regulators entrusted with regulating their products.
Both FDA employees worked in vaccine regulation during the COVID-19 pandemic and joined Moderna—whose only product was its COVID-19 vaccine.
“The revolving door is particularly abusive in agencies that have a huge flood of money going in. That’s a big problem with the FDA,” Craig Holman, a government affairs lobbyist for Public Citizen, told The BMJ.
Holman was referring to the federal funding Moderna received as part of Operation Warp Speed that helped expedite the authorization of COVID-19 vaccines. Holman suggests a “cooling-off period” of at least two years to break down close relationships and networks that could present an ethical problem for employees who leave regulatory agencies for the companies whose products they regulate.
