§356d Coordination; Task Force and Strategic Plan

Summary

The Health and Human Services Secretary must set up a task force as soon as possible after July 9, 2012 to make and carry out a plan to prevent and lessen drug shortages. The plan must cover better coordination and communication inside and between agencies, check for shortages before starting regulatory steps that might cause them, explain how and who to alert outside the agency and what information to share, consider effects on research and clinical trials, and study a possible “qualified manufacturing partner” program (meaning manufacturers who can supply or quickly make drugs in shortage and whether incentives are needed). The task force must work with the right FDA offices and outside experts, publish the plan, and send it to Congress no later than one year after July 9, 2012. Before taking an enforcement action or issuing a warning letter that could reasonably cause a meaningful drug supply disruption, the Secretary must talk with FDA shortage experts about whether the action could cause or make a shortage worse. If it could, the Secretary must weigh the harms from a shortage to patients against the harms from the violation before acting, unless there is an immediate risk of serious injury or death. The Secretary must also create a way for health care providers and other groups to report possible shortages. Decisions under these rules cannot be reviewed by a court and cannot be used as a defense in enforcement. Subsection (a) stopped being effective 5 years after July 9, 2012. Subsections (b), (c), and (e) were not in effect from 5 years after July 9, 2012 until December 29, 2022 and became effective again on December 29, 2022. The Secretary must ensure FDA field investigators and CDER compliance and shortage staff coordinate promptly on reports and follow-up actions.