FDA Continues Critical Audits During the Government Shutdown

FDA announced yesterday that it has called about 400 inspectors back to their job, without pay. About two-thirds of these inspectors will continue audits of drug, device and biologics manufacturing facilities, and the rest for food inspections. FDA emphasized that all inspections or audit will be at “high-risk” manufacturing facilities with means that the efforts are focused to avoid supply chain disruptions for critically needed prescription products, and food. FDA announced that so far none of the scheduled inspections were rescheduled or cancelled. Companies should expect inspectors to show up as planned unless informed otherwise. FDA will also start scheduling new inspections including foreign inspections with the new influx of staff previously furloughed. However, non-critical inspections such a pre-approval inspection for new product decisions, GCP and GLP inspections may be delayed. Although FDA leadership has insisted that they are trying to avoid major issues during the shutdown by re-appropriating available resources, the first signs of the impact are with companies announcing that their marketing approval decisions are delayed due to the shutdown. New applications cannot be submitted, and fees cannot be paid. As the shutdown prolongs, it is almost certain that no government agency, including the FDA, can perform at the normal scale. So additional issues may crop up. With FDA, there is a solution. It could start processing user fees and hence generate revenue to sustain supported functions. Just the way FDA called the inspectors back, it could technically call the staff involved in processing fees and continue operations. We are sure that FDA leadership is exploring all options to continue operations during the extended shutdown. For now, companies with products in the marketplace should continue all regulatory activities as normal and keep submitting information to the FDA.