With the recently announced layoffs of 3,500 FDA staffers and exits of branch directors Patrizia Cavazzoni and Peter Marks, there could be a wealth of talent available to biopharma companies. Does this pose an ethical quandary?
As the FDA wavers from cuts, changes and departures under the second Trump administration, another vital figure of the agency is heading for the exit. | In resigning as director of the FDA’s Center for Biologics Evaluation and Research,
Vaccine makers were hit particularly hard yesterday, as Marks’ resignation letter alluded to disagreements with HHS Secretary Robert F. Kennedy Jr. on vaccines. Moderna’s stock dropped 9%, while Vaxcyte’s plummeted 46% (though shares of Vaxcyte were also affected by disappointing results of a vaccine candidate.)
Dr. Peter Marks, the top vaccine official at the Food and Drug Administration, wrote in a letter that he was resigning from his position.
Marks offered his resignation while citing Kennedy’s “misinformation and lies” and an “unprecedented assault on scientific truth” impacting public health.
Steele, who joined the FDA in 2022, was previously senior adviser at the Center for Biologics Evaluation and Research, which regulates biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies.
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Commissioner Marty Makary signed off on the plan to push out the agency’s top vaccine official, Peter Marks, in one of his first acts as chief,
Dr. Peter Marks, the Food and Drug Administration’s top vaccine regulator, has resigned, an official at the Department of Health and Human Services said Friday.