Strategic Plan, Early Notification to Address Drug Shortages

The FDA announced two actions to enhance the agency’s efforts to reduce the number of drug shortages in the United States: (1) a strategic plan initially required under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012; and (2) a proposed rule requiring that all manufacturers of prescriptions deemed medically important by the FDA to notify the agency of any disruption in the supply chain. According to the FDA, the actions address the potential significant public health threats caused by drug shortages. These actions follow President Obama’s Executive Order 13588 in 2011 intent on reducing drug shortages. Since the Executive Order was issued, the FDA noted that there had been a six-fold increase in the number of notifications. The FDA also reported that new drug shortages were halved in 2012 compared to 2011, from 251 shortages to 117.

Strategic Plan

The FDA’s strategic plan includes measures to improve the agency’s response to imminent or existing shortages, and calls for a long-term approach to ultimately addressing the underlying causes of drug shortages. Drug manufacturers would have opportunities under the strategic plan to prevent shortages through promotion of quality manufacturing. Sent to Congress, the strategic plan would also include actions to: (1) improve the FDA’s communications about shortages, including a new mobile app, so that individuals could instantaneously access drug shortage information via their smart phones; (2) clarify manufacturers’ roles and responsibilities through engagement in practices that would reduce the likelihood of a shortage; and (3) update the FDA’s internal process and procedures for responding to early notification of potential shortages.

Manufacturing and quality issues are also addressed in the FDA’s strategic plan. The FDA would consider broader use of manufacturing metrics for evaluation of manufacturing quality, internal organization improvements to focus on quality, and risk-based approaches to identify early warning signals for manufacturing and quality problems. These issues would be addressed through incentives, as well as the formation of a new office within the FDA’s Center for Drug Evaluation and Research.

Notification Requirement

The notification requirement under the proposed rule would also extend to manufacturers of medically important biologic products and help the FDA address issues prior to the occurrence of a shortage. The proposed rule implements the expanded early notification requirements included in FDASIA. Under early notification, the FDA would have time to: (1) work with manufacturers to investigate the issue leading to the manufacturing disruption; (2) identify other manufacturers who can make up all or part of the shortfall; and (3) expedite inspections and reviews of submissions from manufacturers of drugs that may prevent or mitigate a shortage. The proposed rule will be published officially on November 4, 2013.

Beyond the decrease in the number of new drug shortages in 2012, the FDA noted that it helped prevent 195 drug shortages in 2011 and 282 drug shortages in 2012.