WASHINGTON — The government shutdown could soon jeopardize highly anticipated new drugs from Janssen, Sanofi, and Novartis for depression, diabetes and multiple sclerosis, as well as a host of other potential new therapies, according to a STAT analysis of upcoming regulatory decision dates.
President Trump has warned that the shutdown — already the longest in history — could stretch on for “months or even years.” And though the Food and Drug Administration can retain more than half of its workforce thanks to application fees paid by drug and device makers, Commissioner Scott Gottlieb has cautioned the agency only has about three more weeks’ worth of funding to draw down. The agency can’t accept any new fees during the shutdown.
How to deal with an anticipated crunch: FDA decision on any application gets extended by the duration of the government shut-down (equal burden-share). Thus no preferential treatment, no over-worked FDA staff – just equal delay.
How to deal with a government shut-down : chose a wiser President next time. And force legislation that mandates continued pay to all government employees. They should NOT bare the burden of one man’s decisions !!!
Comments are closed.