On paper, the Food and Drug Administration serves an important role, in part by ensuring pharmaceutical companies demonstrate their products are safe and effective through rigorous, objective, scientific testing. This is what protects us from the avaricious machinations of Big Pharma.

During the pandemic era, though, maintaining such an idealized abstraction of the FDA became a bit more challenging as it approved at warp speed suboptimal vaccines that we were told were safe and effective — and sometimes coerced to take — even as evidence mounted to the contrary .

Given the degree to which this engendered mistrust in the FDA, one would hope the agency would emerge from that period embarrassed, repentant, and ready to earn back the public’s trust. However, recent reports from British Medical Journal senior editor Peter Doshi suggest this is unlikely to happen any time soon — and raise questions concerning how deserving the FDA ever was of the public’s trust prior to COVID-19.

In a recent op-ed published by the Hill, Doshi and two co-authors claim the FDA largely snubbed a petition they and several other scholars submitted to the agency requesting it require updates to the labels of Pfizer’s and Moderna’s respective COVID-19 vaccines to address “obsolete” and “misleading” information.

Among the most notable of the numerous requests made by Doshi and his colleagues was that the FDA require vaccine labels to reflect that relevant drug trials failed to demonstrate that the vaccines prevent viral transmission. They claimed there were widespread misconceptions about this among the general public, at least partly due to unsubstantiated claims by public health officials and various entities such as the FDA suggesting otherwise.

However, in the FDA’s response , the agency, in essence, wrote that because the vaccines that public health officials and entities such as the FDA claimed prevented transmission were never licensed or authorized to prevent transmission, there was no need to highlight the lack of evidence for the ability of the vaccines to prevent transmission. The FDA then went on to question whether anyone was actually confused about this and asserted there was no need for an update to the labels.

The FDA’s responses to many of the other requests in the petition play out similarly.

Furthermore, for those inclined to grant the FDA a three-plus-year mulligan on all things COVID-19, an investigative feature Doshi published in the BMJ suggests the agency’s handling of COVID-19 may not have been the symptom of a temporary ailment, but perhaps a systemic infection.

In his investigative piece, Doshi suggested the FDA in 2019 violated its own rules to approve an application by Merck for a new antibiotic, Recarbrio, to treat certain types of antibiotic-resistant bacterial infections.

According to Doshi, in its drug trials, Merck studied the wrong patient population, using an improper study design that examined not whether Recarbrio was superior to existing treatment options, but whether it wasn’t more than 15% inferior to them. Yet, despite these flaws and Recarbrio ultimately being “as much as 21% worse in effectiveness” than an available generic alternative, Doshi explained, the drug was still approved. Doshi also noted how Recarbrio is “40 times more expensive,” thus raising questions of whether the approval may have been financially motivated.

Given the FDA’s reliance on user fees from drug companies, actions such as those reported by Doshi seem unsurprising and raise questions of possible financial motivations. They also make your kooky aunt and paranoid stoner cousin seem a little less kooky and paranoid, not by validating their claims about what can seem like modern health tonics, but by raising questions about what the agency's approval really means.

Daniel Nuccio is a Ph.D. student in biology and a regular contributor to the College Fix and the Brownstone Institute.