Strategic plan and proposed rule on early notification by manufacturers will help agency build on recent progress
Early notification from manufacturers about possible shortages, as requested in the President’s Executive Order 13588 of Oct. 31, 2011 and then codified into law in FDASIA, has enabled the FDA to work with manufacturers to restore production of many lifesaving therapies. Since the Executive Order, there has been a 6-fold increase in notifications to the FDA.
The notifications received under the existing requirements have resulted in real progress in addressing shortages. The FDA helped prevent 195 drug shortages in 2011 and 282 drug shortages in 2012, leading to a reduced number of new shortages in 2012. The expanded early notification requirements would further enhance the FDA’s ability to address issues prior to the occurrence of a shortage.
The strategic plan, which was required by FDASIA and is being sent to Congress today, describes actions the FDA will undertake to improve its current efforts to respond to early notifications of a potential shortage. These include:
The strategic plan also describes efforts the FDA is considering to address the manufacturing and quality issues that are most often the root cause of drug shortages. These include: