It’s been just reported the fact that the FDA officials have accepted jobs with Moderna after they were involved in COVID-19 vaccine licensure.
FDA officials in trouble
According to an investigation by the British Medical Journal (BMJ), two high-level regulatory officials at the US Food and Drug Administration (FDA) who were responsible for vaccine oversight joined Moderna just a few months after approving the company’s COVID-19 vaccine for licensure.
The report by Peter Doshi, senior editor at The BMJ and associate professor at the University of Maryland School of Pharmacy, highlights the persistent revolving door between pharmaceutical companies regulated by the FDA and the agency’s top officials.
This raises concerns about the impartiality and independence of the FDA’s regulatory decision-makers.
Dr. Doran Fink is an experienced physician and scientist who has specialized in the regulation and clinical development of vaccines and other biological products.
According to his LinkedIn profile, he has more than 12 years of experience in vaccine regulation and was deeply involved in the process during his tenure at the FDA. Dr. Fink began his career at the FDA 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 Office of Vaccines Research and Review. In this role, he led a team of medical officers who focused on infectious diseases and related biological projects.
Dr. Fink was a prominent figure during the COVID-19 pandemic, providing expert opinion on the distribution of COVID-19 vaccines among different population groups.
He represented the FDA at numerous meetings held by the agency’s vaccine advisors to discuss the approval of COVID-19 vaccines, changes to their composition, and the authorization of boosters.
Additionally, as the principal FDA ex officio representative, Dr. Fink presented at meetings held by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, a group of health experts responsible for developing recommendations on the use of vaccines.
Dr. Fink was a part of the senior leadership team for COVID-19 vaccine review and policy activities.
He provided guidance to vaccine manufacturers, coordinated the expedited review of regulatory submissions, advised U.S. government stakeholders outside the FDA, and contributed to FDA guidance on the development, licensure, and emergency use authorization of COVID-19 vaccines. Dr. Fink also conducted a senior-level review of the FDA’s decision memoranda for emergency use authorization and licensure of COVID-19 vaccines, including Moderna’s.
Fink left the FDA in December 2022 and joined Moderna in February 2023 as the head of “Translational Medicine and Early Clinical Development, Infectious Diseases.” Dr. Goswami joined the FDA in March 2020 as a medical officer, responsible for evaluating Moderna’s COVID-19 vaccine clinical data to determine regulatory approval.