More FDA Turnover, Same FDA Problems

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[fusion_dropcap boxed=”no”]P[/fusion_dropcap]resident Trump stunned many when he nominated Robert F. Kennedy Jr. to serve as Secretary of the Department of Health and Human Services. Soon after, he appointed Dr. Marty Makary, another iconoclastic critic of the U.S.’s public health system. 

Less than three months later, the FDA laid off 3,500 (of about 19,700) employees. The rapid downsizing left some concerned that remaining employees would be overworked and overwhelmed. Others feared leaving the agency understaffed would lead to even more sluggish review times. 

These concerns aside, RFK Jr. remained steadfastly committed to reform, insisting that he only fired “corrupt” employees as he brought in his people. But a recent exit casts further doubt.

After serving for about two months, Dr. Vinay Prasad has stepped down from his position as Director of the Center for Biologics Evaluation and Research (a center within the FDA). Some media outlets cite Dr. Prasad, wanting to “spend more time with his family” and that he “did not want to be a distraction” to the Trump administration as reasons for his quick departure.

But these are not the only reasons.

Others point out that Dr. Prasad disagreed with his peers on fast-tracking several experimental treatments. First, he fought against granting access to accelerated approval for several multiple myeloma drugs. Then he also strongly disagreed with his peers on advancing a gene therapy to treat muscular dystrophy. According to a commentary published by Science, these points of difference made the recent appointee “not quite Trumpy enough.”

That is hard to believe. Dr. Prasad expressed many of the same concerns and criticisms of U.S. public health during the pandemic as RFJ Jr. and Dr. Makary. As an accomplished academic, he published many academic articles, gave lectures, and provided testimony questioning many FDA decisions.  Moreover, he was doing so before Trump’s first term.

Dr. Prasad is also not the only appointee to step down after disagreements surfaced. Less than a month ago, RFK Jr. fired two top HHS executives after losing confidence in them. Shortly afterwards, he fired 17 members of a CDC vaccine panel, citing the need to “restore public trust.”

The sad reality is that these hundreds of firings, appointments, and re-appointments have yet to lead to any FDA reforms. The closest the agency has come is a proposed revision of the accelerated approval process, which became a victim of regulatory capture during the pandemic. A lobbying boom from pharmaceutical producers and other healthcare providers since President Trump began his second term lends further pessimism.                                

Restoring trust in the FDA, HHS, and public health broadly requires more than removing people: it requires removing power. RFK Jr., Commissioner Makary, and others have yet to cut regulatory power, they have only replaced who has it. I certainly do not trust that.