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Trump Puts the Squeeze on Science at the FDA

September 1, 2020

Those of us intrepid enough to still follow the news probably already know that a recent reversal by the FDA in the face of pressure from Donald Trump has experts alarmed that the agency’s reliability and political independence is in jeopardy. I don’t have to tell you how bad that is, but I will anyway: it is very bad. Stopping this pandemic requires the cooperation of millions of Americans and many entities throughout our society. Without reliable national leadership, that job becomes much harder, and more people will suffer as a result.

On August 22, Trump tweeted an accusation that the FDA was slow-walking approval for COVID-19 treatments to harm his electoral prospects. The following evening, standing alongside FDA Commissioner Stephen Hahn and Health Secretary Alex Azar, Trump announced an Emergency Use Authorization for a risky, unproven blood plasma treatment, touting the treatment as a major medical breakthrough. In the same period, experts have issued dire warnings about seemingly political decisions at the Centers for Disease Control and Prevention (CDC).

In light of these sobering developments, I wanted to highlight a remark last Sunday from the previous FDA Commissioner, Dr. Scott Gottlieb, on CBS’s Face the Nation. Discussing the prospect of the FDA approving a novel coronavirus vaccine for the general population, Dr. Gottlieb expressed his doubt that researchers working on candidate vaccines could complete the necessary clinical trials before the first half of 2021. Any Emergency Use Authorization for such a vaccine, he stressed, would be limited to specific uses for the most high-risk segments of our population. 

What Gottlieb said next grabbed my attention. “I don’t think the FDA commissioner could step in and obviate a decision by the professional staff,” he said. “And I don’t think he can stop these trials early.”

Obviously, Dr. Gottlieb’s views are informed by his experience overseeing the sausage making of food and drug policy as the former FDA commissioner. His assumption that the commissioner, a presidential appointee, cannot overrule a vaccine (dis)approval decision by the agency’s medical science experts, is critical for bridging the gap between the knowledge-seeking of scientific research and the practical project of regulating medicine on the basis of that scientific research. The FDA’s recent sudden Emergency Use Authorization in the wake of Trump’s accusation makes it harder to trust this process. 

The politicization and hollowing out of expertise at other federal agencies under Trump does not inspire confidence that the FDA will hold firm against his continued onslaught. Our work to protect science-based policy is now that much more urgent. That’s why your support is invaluable as CFI pressures all levels of government—federal, state, and local—to stick to the science.