FDA Issues Rule Tightening Drug Shortage Reporting

In accordance with President Barack Obama’s Executive Order on drug shortages, the Food and Drug Administration (FDA) released an interim final rule tightening restrictions on the reporting of drug shortages by drugmakers. The interim final rule requires drugmakers who are the sole manufacturers of certain drugs to report all disruptions in production —temporary and permanent—by providing at least a six-month warning (situation-permitting) to the FDA. 

Covered drugs would include drugs that are “life supporting, life sustaining or intended for use in the prevention of debilitating disease or condition,” as determined by the FDA on a case-by-case basis.  This rule tightens previous references to temporary discontinuances by requiring disruption reporting “if the discontinuance could lead to a disruption in supply of the product.” 

Over the course of the last two years, ASA has actively led efforts to deal with the drug shortage issue on both the legislative and regulatory fronts.  Part of this effort included co-convening a Drug Shortage Workgroup Summit that issued five legislative and regulatory recommendations.  ASA was encouraged to see the inclusion of the Summit’s recommendation for reporting of interruptions and discontinuation of drugs at least six months in advance. 

Department of Health and Human Service’s Fact Sheet.