FDA targets prescription drug shortages

The U.S. Food and Drug Administration announced Thursday that it was stepping up efforts to prevent and address prescription drug shortages, calling the shortfalls a significant public health threat.

In addition to expanding early reporting requirements for drug manufacturers, the FDA said it was launching a smartphone app that would give consumers instant information on pharmaceutical shortages.

“The complex issues 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,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

From 2010 to 2012, the nation experienced 546 drug shortages, 399 of which involved sterile, injectable drugs. Most of these shortages were caused by quality and manufacturing issues, according to the FDA. Others were caused by a lack of raw materials and components from suppliers.

Drug supply shortages reached an all-time-high in 2010, prompting a 2011 Executive Order from the president to address the issue. The FDA implemented reporting requirements for manufacturers at the time and was also required to draft a strategic plan for preventing and mitigating drug shortages.

That strategic plan was released on Thursday.

The FDA said that with timely notification from a manufacturer about an impending shortage, the agency can determine if other drug makers are able and willing to step of production of the product. The agency said it was also able to work with manufacturers to determine the root cause of the shortage.

New actions the FDA now plans to undertake include improving the agency’s communications about shortages, clarifying drug-makers’ roles and responsibilities in the face of a shortage and internal administrative improvements.

For more FDA information on the drug shortages click here.