The pharmaceutical industry’s top trade group, PhRMA, is pressing the next Food and Drug Administration leader to stabilize an agency rocked by recent turmoil. CEO Steve Ubl declared Wednesday that the priority must be to “calm the waters and reestablish that certainty and predictability” for drug developers.
The plea comes just a day after Commissioner Marty Makary resigned, capping months of upheaval that included staff layoffs and a wave of senior departures. Bristol Myers Squibb CEO Chris Boerner echoed Ubl, noting drug development requires decade-long time horizons and billions in investment, demanding “a very stable FDA that sets consistent rules.”
Ubl acknowledged he does not know acting Commissioner Kyle Diamantas, underscoring the uncertainty facing the agency. The industry is also pushing back on President Trump’s call for Congress to codify drug pricing policies, adding a political dimension to the regulatory concerns.
For companies developing treatments, the lack of predictable oversight could delay clinical trials, raise costs, or shift investment abroad. The trade group’s comments signal that restoring institutional credibility and personnel continuity is seen as critical to the sector’s future.
Critics argue that some past FDA practices slowed innovation and that a leaner, more flexible agency could ultimately benefit patients. The balance between speed and stability remains a core tension in the search for Makary’s permanent successor.