Food and Drug Administration Commissioner Scott Gottlieb warned on Friday that if the partial government shutdown persists, it will force the FDA to make “hard decisions” on preserving key functions of the agency.
See also Novartis' new cell therapy facility could ease manufacturing squeeze for CAR-T med Kymriah
The shutdown has already created consequences for one drugmaker, Aimmune Therapeutics, a California-based biotech company that develops treatments for food allergies.
Aimmune submitted an application and transferred the money needed to pay for the review for its experimental immuno-therapy for peanut allergies the day before the shutdown began. But the company disclosed in a regulatory filing this week that the FDA would not start a review for its treatment until the “shutdown and lapse in appropriations” ended.