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

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.