On July 8, 2015, the federal Food and Drug Administration (FDA) published a final rule requiring drug manufacturers to report to the Agency any supply chain disruptions that could lead to drug shortages. The final rule implements provisions of the Food and Drug Administration Safety and Innovation Action of 2012 (FDASIA) (Pub. L. No. 112-144). FDA believes that this final rule will improve its ability to identify potential drug shortages and to prevent or mitigate the impact of these shortages.
Specifically, the final rule requires all applicants of covered approved drugs or biological products to provide electronic notification to FDA at least six months prior to the date of the permanent discontinuance or interruption in manufacturing of a product that is likely to lead to a meaningful disruption in supply of the product in the United States. “Covered approved drugs or biologicals” is defined in the rule as drugs or biological products that are prescription products that are life supporting, life sustaining, or intended for use in the prevention or treatment of debilitating disease or condition, including any such drug used in emergency medical care or during surgery, and excluding radiopharmaceutical products. The definition also includes certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application. If six months’ advance notice is not possible, notice to FDA must be made as soon as possible, but no later than five business days after the permanent discontinuance or interruption in manufacturing occurred. Such notice must be made by email notification to [email protected] (for products regulated by the Center for Drug Evaluation and Research) and [email protected] (for products regulated by the Center for Biologics Evaluation and Research). In the future, the Agency may consider creating an electronic notification portal to facilitate submission of these notifications.
The final rule specifies the minimum information that must be included in the notification of product discontinuance or interruption (e.g., the name of the drug or biological product subject to the notification, the name of the applicant, whether the notification relates to a permanent discontinuance or an interruption in manufacturing, estimated duration of the interruption, etc.). It also provides that the agency will issue a noncompliance letter to an applicant for failure to notify FDA under the final rule. Lastly, the final rule codifies FDA’s current practice of publically disseminating information on shortages and maintaining public lists of drugs and biological product in shortage.
The final rule is effective September 8, 2015. The proposed version of the rule was published in the Federal Register on November 4, 2013 (78 Fed. Reg. 65904).