Drug shortages pose a significant public health threat as they can delay, and in some cases, even deny critically needed care for patients. Over the past decade, the FDA’s efforts have contributed to fewer new drug shortages and reduced the time to resolve existing drug shortages. This is due, in part, to authorities the agency now has, including those added by the Food and Drug Administration Safety and Innovation Act.
But despite mitigating or preventing hundreds of new drug shortages, disruptions in the U.S. drug supply continue to occur due to drug quality problems, vulnerabilities in the global supply chain, unanticipated increases in demand, market withdrawals of drugs or natural disasters.
