On Wednesday, US President Donald Trump suggested that the recent initiative by the FDA to tighten-up COVID-19 vaccine guidelines was politically-motivated. More specifically, POTUS declared, “That sounds like a political move.” With an imminent election, political tensions are afoot behind the scenes between the White House, the FDA, and other factions in Washington and beyond. FDA’s ultimate mandate and mission is to protect Americans’ public health by diligently assuring safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, and the food supply. In our current pandemic, FDA must ensure that any vaccine candidates are, in fact, safe for mass use.
On October 9, TrialSite reported on FDA’s move to supersede White House intentions. With polls showing that a growing portion of Americans wouldn’t take a vaccine, first the agency needs to build confidence to ensure that its mandate is followed, and perhaps in the process to limit or minimize any politicizing of the drug development process. In relation to this subject, the Washington Post recently reported that the FDA sought new guidance for emergency authorization of COVID-19 vaccines, which effectively eliminated any chance of approval before Election Day. However, POTUS recently declared, “That has to be approved by the White House,” continuing, “We may or may not approve it. It sounds like a political move because when you have Pfizer, Johnson & Johnson, Moderna. These great companies come up with vaccines and they have done testing and everything, I am saying why would be adding great length to the process. I think that was a political move more than anything else.”
Humans are Political Animals
Aristotle suggested, “man by nature is a political animal.” Human beings are emotionally-driven and have an impulse toward allegiance with other fellow humans that share similar views. Why? Aristotle felt humans don’t flourish in a vacuum, but in fact, with others—happiness requires a bond, a partnership with other humans. Hence, fast forward to today in America, a number of what TrialSite refers to as “Camps” have formed with competing agendas for the true core of American society. TrialSite is not in a position to declare right and wrong or share a political opinion. Analysts at TrialSite have certainly witnessed biased behavior, both from POTUS and NIH/NIAID (read our ACTIV article or think about the TrialSite description of how Remdesivir was approved for EUA) and for that matter, how the FDA gave the green light for convalescent plasma. Regardless of their point of view, Americans have more in common than not (as does much of humanity, for that matter). Hence TrialSite suggests the situation merits a reminder of an ancient biblical passage, “He that is without sin among you, let him first cast a stone at her.”
FDA Does Have a Mandate
With a recognition that there is bias everywhere, what matters is strong, methodical, and science-based actions, considering unfolding circumstances of a dangerous pandemic and experimental new vaccines. It is in that spirit that the US FDA mandate and mission must be understood. The FDA was established in its current form by the passage of the 1906 Pure Food and Drugs Act, which wasn’t created in a vacuum, but rather in response to all sorts of dangerous products being peddled throughout America. Remember the old “snake oil” medicinal salesman in the American West? Those stories were based on realities. Over the last century, the FDA emerged as the “Gold Standard” regulatory body, highly respected and followed by other regulatory agencies around the world. Is the FDA biased?—of course—per the segment above. The agency is made up of people who have the same traits as those Aristotle called out a long time ago (just like the rest of us). However, their recent moves are most certainly driven first and foremost by the core driving principles underlying the agency’s existence—protecting human health.
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