President Obama on July 9 signed the Food and Drug Administration Safety and Innovation Act, legislation that includes American Hospital Association-supported provisions to help alleviate critical drug shortages. Approved by Congress June 26, the bill requires drug makers to report production interruptions and discontinuations to the FDA in advance; codifies FDA's authority to speed approval of applications to make drugs in short supply; lifts caps on narcotic ingredients to ensure sufficient supply for anesthesia, pain management and other critical uses; and improves communications with providers and patients about the reason for potential drug shortages and how long they may last. The legislation also creates a user fee program that will help speed FDA approval of generic drugs, and allows hospitals within health systems to conserve their inventory of shortage drugs by sharing repackaged drugs.
“We thank President Obama for signing The Food and Drug Administration Safety and Innovation Act into law today,” said AHA President and CEO Rich Umbdenstock. “The number of drug shortages has tripled in the last six years and they are having an impact on patient care. However, the new law is a concrete step in the right direction in addressing this issue.”