FDA Releases 11th Annual Report on Drug Shortages

https://www.fda.gov/media/179156/download?attachment=&utm_medium=email&utm_source=govdelivery This week the U.S. Food and Drug Administration submitted its annual Report on Drug Shortages to Congress for calendar year 2023. Last year was another challenging year for shortages of critical drugs, including those used to treat cancer, to provide parenteral nutrition, and to address other serious medical conditions. FDA has continued to see manufacturers in the United States and abroad experience quality issues, capacity constraints, and increased demand. Unexpected events like shutdowns, facility closures, and natural disasters also put increased strain on the supply chain. Even with these obstacles, the number of new shortages has decreased significantly over time from the record high of 251 in 2011. In 2023, there were 55 new drug shortages (33 drug shortages handled by the Center for Drug Evaluation and Research and 22 biological product shortages handled by the Center for Biologics Evaluation and Research). FDA worked with manufacturers to successfully prevent 236 more.