FDA announces actions to combat drug shortages

The Food and Drug Administration is taking two actions to enhance its efforts to prevent and resolve shortages of human drugs, including drugs in use in veterinary medicine.

The number of new shortages of human drugs decreased from 251 in 2011 to 117 in 2012 following a presidential order in late 2011 requesting early notification from manufacturers about possible drug shortages.

On Oct. 31, 2013, the FDA released a strategic plan called for in the Food and Drug Administration Safety and Innovation Act of 2012 to improve the agency’s response to imminent or existing shortages and for longer-term approaches for addressing the underlying causes of drug shortages. The plan also highlights opportunities for drug manufacturers and others to prevent drug shortages by promoting and sustaining quality manufacturing.

On Nov. 4, the FDA proposed a rule to implement provisions of FDASIA to require manufacturers of certain medically important prescription drugs to notify the agency of a permanent discontinuance or a temporary interruption of manufacturing likely to disrupt supply. Parties may comment on the rule through Jan. 3, 2014, here.

Early notification gives the FDA time to work with manufacturers to investigate the issue leading to the disruption, identify other manufacturers to make up all or part of the shortfall, and expedite inspections and reviews that might prevent or mitigate a shortage.

“The FDA continues to take all steps it can within its authority, but the FDA alone cannot solve shortages,” said Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research. “Success depends upon a commitment from all stakeholders.”