To enhance FDA’s ongoing efforts to prevent and resolve drug shortages, the agency released a strategic plan and issued a proposed rule requiring certain manufacturers to notify the agency of supply disruptions, FDA announced in a press release. The strategic plan, called for in the FDA Safety and Innovation Act (FDASIA) of 2012, aims to improve the agency’s response to imminent or existing shortages and outlines longer-term approaches for addressing the underlying manufacturing and quality issues that are most often the root cause of drug shortages.
According to the strategic plan, actions FDA will undertake to improve its current efforts to respond to early notifications of a potential shortage include improving communications, clarifying manufacturers’ roles and responsibilities, and updating internal FDA procedures. Longer-term actions to address underlying manufacturing and quality issues include: broader use of manufacturing metrics to assist in the evaluation of manufacturing quality as well as incentives for high-quality manufacturing; internal organization improvements to focus on quality, which would include a proposed Office of Pharmaceutical Quality within the Center for Drug Evaluation and Research (CDER); and risk-based approaches to identify early warning signals for manufacturing and quality problems, the agency reported in the press release.
FDA also issued a proposed rule requiring all manufacturers of certain medically important prescription drugs to notify FDA of a permanent discontinuance or a temporary interruption of manufacturing likely to disrupt their supply. The rule extends this requirement to manufacturers of medically important biologic products. The proposed rule will be published on Nov. 4, 2013 and will be open to public comment.
The proposed rule implements the expanded early notification requirements included in FDASIA. “The complex issue of drug shortages continues to be a high priority for the FDA, and early notification is a critical tool that helps mitigate or prevent looming shortages,” said Janet Woodcock, director of CDER in the press release. “The FDA continues to take all steps it can within its authority, but the FDA alone cannot solve shortages. Success depends upon a commitment from all stakeholders.” Early notification gives FDA time to work with manufacturers to investigate the issue leading to the manufacturing disruption, identify other manufacturers who can make up all or part of the shortfall, and expedite inspections and reviews of submissions from manufacturers of drugs that may prevent or mitigate a shortage, explained FDA.
Early notification from manufacturers about possible shortages, as requested in the President’s Executive Order 13588 of Oct. 31, 2011 and then codified into law in FDASIA, has increased sixfold since the issue of the executive order, which has resulted in progress in addressing shortages, said FDA in the press release. The FDA helped prevent 195 drug shortages in 2011 and 282 drug shortages in 2012, leading to a reduced number of new shortages in 2012. The expanded early notification requirements would further enhance the FDA’s ability to address issues prior to the occurrence of a shortage.