§356d Coordination; task force and strategic plan

Summary

The Secretary of Health and Human Services 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 inside and between agencies, how to avoid causing shortages when making regulatory decisions, how and who to warn outside groups about possible or real shortages, how shortages affect research and clinical trials, and whether to create a “qualified manufacturing partner” program. That program study must look at whether a partner has the ability and quick capacity to make drugs in short supply and whether incentives are needed to get companies to join. The task force must consult FDA offices and other HHS experts and talk with outside stakeholders. The task force had to publish the plan and send it to Congress within 1 year after July 9, 2012. Before taking an enforcement action or sending a warning letter that could meaningfully disrupt the U.S. supply of drugs described under section 356c(a), the Secretary must talk with FDA shortage experts and, if the action could cause or make a shortage worse, weigh the risks to patients before acting unless there is an imminent risk of serious harm or death. The Secretary must also provide a way for providers and other groups to report shortage evidence. Decisions under this law cannot be reviewed by courts and do not create a legal defense to an enforcement action. Subsection (a) ended 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 also make sure FDA field investigators and the Center for Drug Evaluation and Research coordinate on report reviews and any follow-up actions.