Tracy Beth Høeg was named acting director of the FDA’s CDER, a move senior officials say followed the resignation of Richard Pazdur and clashes with Marty Makary that also preceded the exit of Peter Marks.Senior regulators and industry insiders reported internal complaints, layoffs and alarm among staff who said Høeg lacks experience overseeing drug reviews, with one official calling the decision “like dropping an atom bomb” and others saying she “doesn’t understand laws and regulations.”Industry groups warned the shake-up could politicize
FDA decision-making, damage the agency’s reputation as a regulatory standard and prompt some companies to move drug development overseas to seek more stable oversight.