December 11, 2013
On November 4, 2013, FDA issued a proposed rule regarding manufacturer notification to FDA of drug shortages due to a permanent discontinuance or unplanned interruption in manufacturing. The FDA Safety and Innovation Act (Act) required FDA to promulgate the proposed rule, and ultimately the final rule, by January 9, 2014. Under the Act, all manufacturers of certain drugs and biologics must notify the FDA six months in advance of a drug or biologic shortage in order to aid FDA’s efforts to prevent, mitigate and publicize these shortages. FDA’s recent activity stemmed from 250 drug shortages in 2011, and 117 shortages in 2012. FDA believes these shortages likely caused prescriptions of second-rate alternative drugs and biologics that could have resulted in greater risks for patients.
In conjunction with the proposed rule, FDA also developed a strategic plan for the prevention and mitigation of drug shortages. In the strategic plan, FDA identified two central goals to address shortages: (1) improving the mitigation response to imminent or existing shortages; and (2) implementing strategies for the long-term prevention of shortages by focusing on the root cause of shortages. FDA identified specific tasks to meet those goals and specific areas in which FDA will seek external stakeholder attention. Overall, the FDA believes “early and open dialogue between FDA and manufacturers is critical to successfully mitigating and preventing shortages.” The proposed rule is an attempt by FDA to require the dialogue it believes is critical for successfully mitigating and preventing shortages.
The comment period for this proposed rule ends on January 3, 2014. If you have any questions about FDA’s proposed rule or strategic plan, please contact one of the authors.