Shutdown Might Prevent Drug Approvals

FDA has limited funds to keep the process on track.

People suffering from depression, diabetes, and multiple sclerosis, among other ailments, might wind up missing out on new medications thanks to the government shutdown. Stat takes a look at upcoming regulatory decision deadlines slated for pharmaceuticals from Janssen, Sanofi, and Novartis.

The FDA has been able to keep about half its workforce on the job thanks to fees already paid by manufacturers of drugs and medical devices, but that money will probably run out in a few weeks. New fees cannot be accepted during the shutdown. 

“More than ten drug makers, however, are expecting the FDA to make a decision on their products in March—after [FDA Commissioner Scott] Gottlieb anticipates the agency will run out of funds,” Stat reports. “And any delay in decisions expected in March could have ripple effects that delay other highly-anticipated products, like, for example, GlaxoSmithKline’s HIV treatment Tivicay/Epivir.”

The FDA is working on a plan for what to do when the funding runs out, and lawmakers are itching to see it. Last Friday, 34 Democratic senators sent Gottlieb a letter asking for specifics. Gottlieb promises to address the situation this week.