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’s advocacy 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.
Over the past two years, ASH has taken a number of steps to resolve drug shortages, including working with manufacturers, FDA and Congress. Most recently the Society submitted comments to the FDA on the draft strategic plan, which focused on urging the Agency to include biologics in the early notification requirements; work more closely with other federal agencies to mitigate shortage problems; continue its current tactics to mitigate product shortages, but at a faster pace; and increase communication to specialty groups about shortage information. ASH's comments also addressed the negative impact drug and biologic shortages have on clinical research. In 2012, ASH met with FDA leaders to discuss the importance of including biological products under the advanced notification requirements authorized by FDASIA. ASH’s advocacy was instrumental to ensuring the inclusion of biologics in both the strategic plan and the proposed rule.
In the coming weeks, ASH will release a detailed summary and analysis of the strategic plan and proposed rule and their impact on hematology. The Society will also submit comments to the FDA on the proposed rule. Please contact ASH Government Relations and Practice Manager Stephanie Kaplan with any comments you have about the proposed rule.
Visit ASH’s drug shortage information webpage for more information about current hematologic drug shortages, ASH’s advocacy efforts, and resources for physicians dealing with shortages.
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