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FDA issues proposed rule, plan for early notice of drug shortages

October 31, 2013

The Food and Drug Administration today released a proposed rule requiring all makers of certain medically important prescription drugs to notify FDA of permanent discontinuances or temporary interruptions in manufacturing that are likely to disrupt their supply, as required by the Food and Drug Administration Safety and Innovation Act of 2012. The rule also would extend the early notification requirement to medically important biologic products. In addition, FDA today sent Congress a strategic plan for strengthening the agency’s ability to respond to imminent or existing drug shortages and for developing longer-term approaches to address the underlying causes of production disruption, also required by the 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, M.D., director of the FDA’s Center for Drug Evaluation and Research. The agency will accept comments on the provisions of the proposed rule for 60 days after publication in the Nov. 4 Federal Register, and comments on the information collection requirements for 30 days after publication.