Consternation follows Marks’ FDA departure

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In late March, the US Food and Drug Administration’s (FDA) director of the Center for Biologics Evaluation and Research, Peter Marks, resigned under pressure from Health and Human Services Secretary Robert F. Kennedy. In his resignation letter Marks said he had been asked to hand in data on measles vaccine-related deaths and brain swelling that do not exist.

Marks’ resignation corresponds with a massive government cull from across Health and Human Services seeking to eliminate at least 3,500 jobs from the FDA, 2,400 from the Centers for Disease Control and Prevention and 1,200 from the National Institutes of Health. With many of the top jobs at the FDA vacant as a result of layoffs, resignations and a hiring freeze, public and industry leaders are sounding the alarm. David Kessler, a former FDA commissioner, warns, “If these cuts are not rescinded, they will have an effect for decades.”

Jeremy Levin, Ovid CEO, is among over 200 industry leaders, investors and patient advocates who penned a letter to US Senate Health, Education, Labor and Pensions committee chairman Bill Cassidy, Republican of Louisiana, raising concerns about the state of the agency: “Specifically, we worry that the institutional knowledge that makes the FDA the world’s leading regulatory body will be irretrievably lost.” In addition to jobs, the administration has slashed science funding, particularly for programs involving infectious diseases such as HIV and COVID-19 and for vaccines and LGBT-related projects. Nearly 800 research projects have been terminated and by April more than $2.3 billion had been cut.