FDA Finalizes ASA-Supported Manufacturer Requirement for Drug Shortages

In a positive step towards preventing and mitigating drug shortages, the Food and Drug Administration (FDA) finalized a rule requiring drug manufacturers to notify the FDA of a permanent discontinuance or interruption in the manufacturing of certain drugs.  In the final rule, the FDA agreed with ASA that manufacturers are required to report shortages of anesthetics and analgesics, as well as shortages of prescription drug products marketed without an approved application which have been used by physician anesthesiologists for decades and are critical to safe anesthesia care. 

This final rule represents another critical step in an ongoing effort to address drug shortages.  In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law, which is a legislative package of important FDA provisions that includes Title X, a section dedicated solely to preventing and mitigating national drug shortages.  As a direct result of ASA’s advocacy, FDASIA requires manufacturers to report to the FDA a permanent discontinuance or interruption in the manufacture of drugs that are “life supporting, life sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery.”  This month, the FDA is celebrating the third anniversary of FDASIA, and Acting Commissioner Stephen Ostroff, M.D. blogged about the FDA’s progress implementing this law.

In addition, the U.S. Government Accountability Office has interviewed ASA and published reports on drug shortage trends and the causes of shortages,  and on shortages of controlled substances.  In 2013, the FDA released a strategic plan on drug shortages in which it says that the agency will work with ASA to develop long-term prevention strategies on shortages.  ASA has also co-convened three drug shortage summits to develop recommendations that will reduce drug shortages, and continues to work closely with the FDA and stakeholders to identify solutions to shortages.