Earlier this week, two new leaders of the US Food and Drug Administration published a list of priorities for the agency. Both Marty Makary and Vinay Prasad are controversial figures in the science community. They were generally highly respected academics until the covid pandemic, when their contrarian opinions on masking, vaccines, and lockdowns turned many of their colleagues off them.
Given all this, along with recent mass firings of FDA employees, lots of people were pretty anxious to see what this list might include—and what we might expect the future of food and drug regulation in the US to look like. So let’s dive into the pair’s plans for new investigations, speedy approvals, and the “unleashing” of AI.
First, a bit of background. Makary, the current FDA commissioner, is a surgeon and was a professor of health policy at the Johns Hopkins School of Public Health. He initially voiced support for stay-at-home orders during the pandemic but later changed his mind. In February 2021, he incorrectly predicted that the US would “have herd immunity by April.” He has also been very critical of the FDA, writing in 2021 that its then leadership acted like “a crusty librarian” and that drug approvals were “erratic.”
Prasad, an oncologist, hematologist, and health researcher, was named director of the FDA’s Center for Biologics Evaluation and Research last month. He has long been a proponent of rigorous evidence-based medicine. When I interviewed him back in 2019, he told me that cancer drugs are often approved on the basis of weak evidenc