Two former FDA officials who were involved in regulating COVID-19 vaccines have recently taken jobs with vaccine maker Moderna, prompting conflict of interest concerns.
Moderna has seen billions in revenue from its COVID-19 shot, which was granted emergency use authorization by the FDA in December 2020. The company currently only has one product on the market: its mRNA COVID vaccine.
Concerns Raised Over ‘Revolving Door’ Between Regulators and Industry
In an investigative report published this week in The BMJ, a leading medical journal, author Dr. Peter Doshi highlighted the moves of Dr. Doran Fink and Dr. Jaya Goswami from the FDA to Moderna.
Dr. Fink joined the FDA in 2019 as a lead medical officer and later became acting deputy director of the Office of Vaccines Research and Review in April 2022, according to his LinkedIn profile. Less than a year later, he took on a role at Moderna heading translational medicine and early clinical development for infectious diseases.
Dr. Goswami was a medical officer at the FDA’s Center for Biologics Evaluation and Research for over two years before leaving to join Moderna in June 2022, her LinkedIn shows.
The BMJ report warned that officials cycling between regulating and working for pharmaceutical companies, sometimes called the “revolving door,” could pose conflicts of interest.
In particular, employees who worked on vaccines during the pandemic and then joined a leading vaccine maker like Moderna warrant scrutiny, the report stated.
Past ‘Revolving Door’ Cases Raise Similar Issues
This issue gained attention previously when former FDA Commissioner Dr. Scott Gottlieb took a board position with Pfizer after departing the agency in 2019. He remained on Pfizer’s board throughout the pandemic as the company brought a leading COVID vaccine to market.
The ‘revolving door’ between regulators and industry threatens to degrade public trust and allow companies to gain favorable treatment, according to a 2005 report cited by The BMJ.
Critics argue regulators still in contact with former FDA colleagues may leverage those relationships for preferential treatment for their new private sector employers. They also argue regulators hoping for future industry jobs could make decisions favoring prospective employers.
Current Rules Attempt to Limit Conflicts
There are restrictions in place meant to limit potential conflicts of interest from the ‘revolving door.’ FDA officials who join pharmaceutical firms are prohibited from testifying to the government on the company’s behalf on issues they worked on while at the agency.
Regulators are also required to recuse themselves from matters related to their future private sector employer while still at the FDA and in the process of negotiating employment.
However, critics argue enforcement of ethics rules relies heavily on self-policing.
“The FDA has more enhanced ethics restrictions than most other federal agencies,” an agency spokesperson told The BMJ. “[The FDA] takes seriously its obligation to help ensure that decisions made and actions taken, by the agency and its employees, are not, nor appear to be, tainted by any question of conflict of interest.”
Still, close relationships between regulators and industry continue to raise concerns that profit is prioritized over public health. The large influx of funds to the FDA from user fees paid by pharmaceutical companies adds further doubts about impartiality.
In summary, the recent moves of high-level FDA vaccine regulators to COVID vaccine maker Moderna have amplified worries over an overly cozy relationship between the pharmaceutical industry and its government regulators. The ‘revolving door’ between the two sectors threatens to undermine public trust in health agencies and the safety decisions they make.