Several former officials from the U.S. Food and Drug Administration (FDA) have come under scrutiny for securing lucrative positions with pharmaceutical companies after playing pivotal roles in the approval process for their respective Covid vaccines. This investigative revelation about the so-called “revolving door” was brought to light by the esteemed British Medical Journal (BMJ).
This situation draws parallels to the case of former FDA official Curtis Wright IV, who played a key role in approving the highly addictive opioid OxyContin for Purdue Pharma in 1995. Following this approval, he left the FDA and joined Purdue Pharma, receiving a substantial salary. Wright’s actions are widely acknowledged to have contributed to the ongoing opioid crisis in the United States.
The BMJ’s recent investigation suggests a comparable scenario may have unfolded concerning the approval of Covid vaccines, particularly Moderna’s mRNA injection. Two FDA regulatory officials, deeply involved in vaccine oversight, reportedly accepted positions at Moderna shortly after endorsing the licensure of the company’s COVID-19 vaccine.
These officials played a crucial role in approving the vaccines for public use, leading to substantial profits for pharmaceutical companies from the sale of these injections after approval. The investigation, authored by Peter Doshi, an associate professor at the University of Maryland School of Pharmacy and senior editor at The BMJ, has exposed a historical pattern of a revolving door between the FDA and the pharmaceutical companies it regulates, raising concerns about the impartiality and independence of top FDA regulators.
One of the implicated individuals is Dr. Doran Fink, a physician/scientist with extensive experience in vaccine regulation. Dr. Fink had a more than 12-year tenure at the FDA, beginning as a clinical reviewer in 2010 and progressing to become the Deputy Director of the Division of Vaccines and Related Product Applications within the FDA’s Office of Vaccines Research and Review.
During the COVID-19 pandemic, Dr. Doran Fink emerged as a notable figure in discussions about COVID-19 vaccines and their distribution among different population groups. He represented the FDA at numerous meetings held by the agency’s vaccine advisors, where topics such as the approval of COVID-19 vaccines, potential changes to their composition, and the authorization of boosters were deliberated. Dr. Fink also presented at meetings convened by the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices in his capacity as the FDA’s principal representative.
As indicated by the BMJ report and Dr. Fink’s LinkedIn profile, he played a role in the senior leadership team overseeing COVID-19 vaccine review and policy activities in response to the pandemic. His responsibilities included advising vaccine manufacturers on development, coordinating expedited regulatory reviews, providing guidance on vaccine development, licensure, and emergency use authorization. Notably, Dr. Fink participated in a senior-level review of the FDA’s decision memoranda for the emergency use authorization and licensure of COVID-19 vaccines, including Moderna’s.
Dr. Fink left the FDA in December 2022 and subsequently joined Moderna in February 2023 as the head of “Translational Medicine and Early Clinical Development, Infectious Diseases.”
Another individual under scrutiny is Dr. Jaya Goswami, who began working as a medical officer at the FDA’s Center for Biologics Evaluation and Research in March 2020. According to the BMJ report, Dr. Goswami had broad oversight over vaccines and biologics clinical development, specifically evaluating the clinical data for Moderna’s COVID-19 vaccine. After Moderna’s SPIKEVAX received FDA approval in January 2022, Dr. Goswami left the FDA in June 2022 and joined Moderna as the director of clinical development in infectious diseases.
Both instances highlight a perceived “revolving door” between the FDA and pharmaceutical companies, raising concerns about impartiality and independence. Critics, including Craig Holman from Public Citizen, emphasize the need for a “cooling-off period” to address potential conflicts of interest. The FDA, while asserting its commitment to ethical standards, faces calls for greater transparency in post-employment records and clearance procedures. This investigation adds to ongoing discussions about the regulatory-corporate relationship and its implications for public health.