The U.S. Senate on June 26 voted 92-4 to approve the Food and Drug Administration Safety and Innovation Act, which includes American Hospital Association-supported provisions to help alleviate critical drug shortages. The legislation now goes to the president, who is expected to sign it into law.
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.
“This bill is a concrete step in the right direction in addressing the growing number of drug shortages, which affect hospitals’ ability to provide patient care,” said AHA President and CEO Rich Umbdenstock. “In order to provide every patient with the right care, given at the right time, in the right setting, it is important that hospitals have access to the right drugs.”