The sudden end of Marty Makary’s tenure as Food and Drug Administration commissioner adds to a leadership void that’s left biotechnology industry watchers anxious about which direction the agency will take next.
With the appointment of Kyle Diamantas as the FDA’s temporary leader, three of the agency’s top positions involving drug reviews and regulation are now manned by people in “acting” roles. All three have a 210-day time limit for authority under federal law.
That deadline makes it likely the FDA will see even more turnover in the near future, as the White House and Department of Health and Human Services Secretary Robert F. Kennedy Jr. seek full-time replacements in the event the current occupants aren’t nominated. The situation also leaves unclear whether the next nominee will carry forward some of the biotech-friendly initiatives Makary endorsed, or take a more antagonistic stance instead.
“The next steps will determine whether the FDA restores scientific depth, institutional credibility, and global confidence — or whether America surrenders its preeminence in biotechnology to competing nations that understand scientific institutions are strategic national assets,” wrote Jeremy Levin, board chair of Ovid Therapeutics and a longtime biotech executive, in a LinkedIn post.
