21 U.S.C. § 356d — Coordination; task force and strategic plan

(a) Task force and strategic plan. Soon after July 9, 2012, the Secretary had to establish a task force to develop and carry out a strategic plan for improving the Secretary's response to preventing and mitigating drug shortages. That plan had to include: plans for better interagency and intra-agency coordination, communication, and decisionmaking; plans for considering drug shortages before the Secretary takes a regulatory action that could cause or worsen one; plans for effective communication with outside stakeholders — who to alert, how, and what information to share; plans for considering how shortages affect research and clinical trials; and an examination of whether to create a "qualified manufacturing partner program." In examining that program, the Secretary had to consider that a "qualified manufacturer" would need the capability and capacity to supply products in shortage — which could mean having a site that makes a listed drug, or having the capacity to quickly ramp up production — and had to examine whether incentives were needed to get manufacturers to participate. The task force had to consult with relevant FDA offices (including the Commissioner's office, the drug evaluation center, and the regulatory affairs office) and HHS staff with shortage expertise, and engage outside stakeholders and experts as appropriate. Within 1 year of July 9, 2012, the task force had to publish the strategic plan and submit it to Congress. (b) Communication. Before taking an enforcement action or issuing a warning letter that the Secretary determines could reasonably be expected to cause a meaningful disruption in the U.S. supply of a drug described in section 356c(a), the Secretary must first communicate with the appropriate FDA office that has shortage expertise about whether the action or letter could cause or worsen a shortage. (c) Action. If, after that communication, the Secretary determines an enforcement action or warning letter could reasonably cause or worsen a drug shortage, the Secretary must weigh the risk to patients from the shortage against the risk from the underlying violation before taking the action or issuing the letter — unless there's imminent risk of serious harm or death. (d) Reporting by other entities. The Secretary must identify or establish a way for health care providers and other outside organizations to report evidence of a drug shortage to the Secretary. (e) Review and construction. No determination, finding, action, or omission by the Secretary under this section is subject to judicial review, and none can be used to establish a defense against an FDA enforcement action. (f) Temporary sunset. Subsection (a) stopped being effective 5 years after July 9, 2012. Subsections (b), (c), and (e) were not in effect starting 5 years after that date through December 29, 2022, and came back into effect on December 29, 2022. (g) Coordination. The Secretary must ensure timely, effective internal coordination between FDA field investigators and the Center for Drug Evaluation and Research's Office of Compliance and Drug Shortage Program staff, regarding reviews of reports shared under section 374(b)(2), and any feedback or corrective or preventive actions responding to those reports.