SILVER SPRING, Md. — The Food and Drug Administration is using long-term strategies to address drug shortages when they appear and requiring manufacturers to notify the agency if a shortage is at risk of happening, under a new plan announced Thursday.
The FDA said it would take two actions to improve its efforts to prevent and resolve drug shortages, which have become a problem in recent years, though an executive order by president Barack Obama two years ago reduced the number of shortages in 2012 to 117, from 2011's 251. The agency said it was able to prevent 195 shortages in 2011 and 282 in 2012.
First, the agency will release a strategic plan for improving its response to imminent or existing shortages and longer-term approaches for addressing the underlying cause of shortages, as mandated by the Food and Drug Administration Safety and Innovation Act of 2012, also known as FDASIA. The plan includes launching a new smartphone app that would allow consumers to instantaneously access drug shortage information; clarify manufacturers' roles and responsibilities by encouraging them to take steps to reduce the likelihood of shortages; and update the FDA's internal procedures for responding to early notifications of potential shortages. Other provisions in the plan would allow broader use of manufacturing metrics to evaluate manufacturing quality, such internal organizational changes as a proposed Office of Pharmaceutical Quality within the FDA's Center for Drug Evaluation and Research and risk-based approaches for identifying early warning signals of manufacturing and quality problems.
Second, a proposed rule would require all manufacturers of certain medically important prescription pharmaceutical and biologic drugs to notify the FDA of a permanent discontinuance or temporary interruption of manufacturing that is likely to disrupt supply. The rule would implement an expanded early notification requirement included in FDASIA. The FDA said early notification would allow it to work with manufacturers to investigate issues leading to manufacturing disruption, identify other manufacturers that can make up for the shortfall and expedite inspections and reviews of regulatory approval applications for products that might prevent or mitigate a shortage.
"The complex issue of drug shortages continues to be a high priority for the FDA, and early notification is a critical tool that helps mitigate or prevent looming shortages," FDA CDER director Janet Woodcock said. "The FDA continues to take all steps it can within its authority, but the FDA alone cannot solve shortages. Success depends upon a commitment from all stakeholders."