FDA Provides Update on Work to Mitigate Shortages of IV Drugs

Food and Drug Administration Commissioner Scott Gottlieb, M.D., yesterday shared an update on the agency’s work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities. Among other actions, Gottlieb said FDA is “evaluating our current authorities to see what more we can do to better mitigate and prevent shortages, including receiving additional, key information from industry when they notify the agency about a possible shortage and identifying all establishments where manufacturing is performed associated with listed drugs and the type of operation performed at each such establishment.” In addition, Gottlieb said the agency could ask Congress to expand its authority to require manufacturers to conduct risk assessments “to identify the vulnerabilities in their drug supply, including vulnerabilities that could cause a shortage, and establish risk mitigation plans to address those risks.”