ASH Advocacy Influences FDA’s Action to Address Drug Shortages November 1, 2013

On October 31, the U.S. Food and Drug Administration announced two actions to enhance the Agency’s efforts to prevent and resolve drug shortages. ASH’sadvocacy efforts to combat drug shortages successfully impacted FDA’s actions. First, the FDA released the strategic plan called for in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, which outlines FDA’s plans to enhance its response to preventing and mitigating drug shortages. The plan sets two goals for the agency: 1. to improve and streamline the agency’s response to imminent or existing shortages, and 2. to develop long term prevention strategies to address the underlying causes of supply disruption and to prevent drug shortages. The plan also highlights opportunities for drug manufacturers and others to prevent shortages of drugs and biologics by promoting and sustaining quality manufacturing.

Second, the FDA issued a proposed rule requiring all manufacturers of certain medically important prescription drugs and biological products to notify the FDA of a permanent discontinuance or a temporary interruption of manufacturing likely to disrupt their supply. ASH strongly advocated for the inclusion of biologics in FDASIA’s provisions calling for advanced notification of manufacturing interruptions that could result in a shortage and is extremely pleased to see that this policy was included in the proposed regulation.

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