Thursday, November 9, 2023

UNCOVERED! The Revolving Door between the FDA and Moderna - by JUSTIN HART

The unsettling alliance between the United States Food and Drug Administration (FDA) and pharmaceutical giant Moderna beggars closer scrutiny. As reported by Peter Doshi in a recent British Medical Journal (BMJ) article, the FDA's lackadaisical rules have seemingly cultivated a comfortable arena for a revolving door culture. A prime illustration of this issue is the suave transition of physician-scientist Doran Fink from an influential public office at the FDA to a high-ranking position in Moderna, a company which he previously regulated.

For over a decade, Fink carved a credible role within the FDA, more notably in vaccine regulation. During the COVID-19 pandemic, he expanded his influence even further, partaking actively in critical policy meetings, and playing a significant role in authorizing Pfizer’s and Moderna's vaccines. However, the concern is not simply in Fink's switch of roles, but the quite comfortable revolving door culture unmindful of potential conflicts of interest it fosters.

The term "revolving door" denotes the movement of personnel between government offices and private sector roles. In an ideal world, the distinction is clear - those in the public sector are meant to serve public interest, as opposed to private sector employees, who cater to the interests of their respective organizations. Craig Holman, a prominent lobbyist for the consumer advocacy organization Public Citizen, suggests that safeguarding the integrity of public office is integral. His notion of a "cooling-off" period before transitioning from public service to private sector roles aims at diluting the close ties and networks that might influence decision-making.

What is unnerving is that the FDA does not maintain any records tracing where their employees head post-public service, nor is any clearance required prior to taking up industry roles. While they do have post-employment guidance, adherence is, at best, self-enforced. This loophole, alarming as it is, becomes particularly concerning when massive fluxes of funding are involved, as was the case with the FDA during the pandemic through Operation Warp Speed.

While the case of Doran Fink is noteworthy, he is not alone in this trend. Similar to Fink, Jaya Goswami started at the FDA in March 2020, overseeing vaccines and biologics clinical development before moving on to hold a position at Moderna. This prevalent shift underscores a deeply rooted problem requiring immediate attention.

The contours of a cosy relationship between the FDA and Moderna can be traced back to the onset of the COVID-19 pandemic. Prior to the pandemic, Moderna, despite a decade of operations, had no marketed product. The shift coincides with the appointment of Moncef Slaoui, a Moderna board member, as co-lead of Operation Warp Speed. Ethical concerns were rife, but Slaoui avoided formal scrutiny by taking the job as a contractor, not a government employee.

The dilemma we face is multifold. Firstly, we must ensure that public officials serve the interests of the public, not those of future employers. Secondly, agencies like the FDA must implement stricter rules governing post-public service employment. Lastly, transparency in governmental decision-making must be paramount, and any appearance of a conflict of interest should be firmly deterred if we are to restore the waning public confidence in the decisions made for our public health.