FDA’s ‘key man’ Peter Marks is out. Biotech investors will now deal with the consequences

March 30, 2025

Robert F. Kennedy Jr. forcing Peter Marks out of the Food and Drug Administration has blown a hole in the agency’s leadership ranks and threatens to unmoor the oversight of drugs and vaccines from bedrock scientific principles. 

For biotech investors, Marks’ ouster is a worst-case scenario realized — an FDA riven by dysfunction and uncertainty. And it comes at a time when the sector is already suffering through a years-long public markets slump

A crisis in confidence at the FDA is potentially calamitous. Investing in biopharma companies becomes exceedingly difficult if the regulatory agency in charge of evaluating and approving life-saving (and money-making) medicines stops following predictable, well-established standards.

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