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FDA Issues Rule to Improve Manufacturer Notifications Regarding Potential Drug Shortages
Food and Drug Administration (FDA) issued an interim final rule that will require manufacturers that are the only producer of certain drug products to report to FDA all interruptions in manufacturing that could lead to drug shortages. This rule applies to products that are life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition. As explained in the US Department of Health and Human Services (HHS) fact sheet, early notification of potential drug shortages is an essential tool in helping FDA work with drug manufacturers, hospitals, health care providers, and patients to prevent or mitigate drug shortages. Responding to President Obama’s Executive Order issued October 31, 2011, FDA’s issuance of the rule is one of several steps the agency is taking to address the issue of drug shortages and continues progress made in 2010 and the first eight months of 2011. HHS reports that FDA prevented 233 shortages in the past two years, and that awareness raised by the President’s executive order and an FDA letter to manufacturers has resulted in a six-fold increase in voluntary notifications in November 2011 compared with prior months.
FDA actions are consistent with recommendations of the Government Accountability Office (GAO). GAO’s report, “Drug Shortages: FDA's Ability to Respond Should Be Strengthened,” issued December 15, 2011, recommended that “Congress should consider establishing a requirement for manufacturers to report to FDA any changes that could affect the supply of their drugs” and also supported the creation of an information system for managing data about drug shortages. The GAO report concluded that “when informed of the possibility of a shortage in advance, FDA has increasingly been able to prevent potential drug shortages from occurring,” but that lack of authority to require manufacturers to report actual or potential shortages has made this task a challenge.
