ASA Supports New FDA Guidance on Drug Shortages

Last week, the American Society of Anesthesiologists (ASA) submitted formal comments in support of the Food and Drug Administration’s (FDA) new drug shortage guidance. The new guidance, which targets notification for drug production interruption and discontinuation, assists drug manufacturers in “providing FDA timely, informative notifications about changes in the production of certain finished drugs and biological products as well as certain active pharmaceutical ingredients (API) that may, in turn, help the Agency in its efforts to prevent or mitigate shortages.” This FDA guidance is an important step in ensuring adequate and consistent patient access to drugs that improve outcomes and care.  

The guidance highlights the importance of notifications to the FDA to maintain awareness of availability of drugs that are needed to care for patients. Enhanced communication between manufacturers and the FDA ensures that all stakeholders receive relevant information as quickly as possible.  

Based on prior recommendations drafted at a 2018 ASA-convened summit on drug shortages, the 2023 comment letter also offered the FDA additional recommendations, including:

• Incentivize compounding pharmacies and manufacturers to increase production and reduce costs.  
• Coordinate with partners in other countries to streamline international regulations and incentivize increased production.  
• Support and explore methods to assess the risk of foreign sourced active pharmaceutical ingredients (API).  
• Encourage manufacturers to develop contingency or redundancy plans for drug production, specifically when there are fewer than three manufacturers producing a drug or when the drug is identified as “critical.”  
• Convene discussions between manufacturers, hospitals, medical stakeholders, and others that assess current regulations on repackaging medications, including single-dose vials.
• Participate in and encourage cross-collaboration on drug concentration standardization actions, including by standardizing medical concentration, containers, and sizes to stabilize pharmaceutical supply and reduce the probability of patient harm.  
• Ensure that the health care provider community can manage drug shortages via up-to-date technology and early communication about potential drug shortages.  

This week, the FDA submitted its annual Report on Drug Shortages to Congress, which highlights the COVID-19 pandemic’s continuing strain on the pharmaceutical supply chain and summarizes actions taken by the FDA to mitigate or prevent shortages. Anesthesiologists began reporting rising shortages of equipment and medical devices, such as certain epidural kits, syringes, and IV/A-line catheters, in July 2022. 

The FDA maintains a list of medical devices in shortage, but manufacturers have no legal obligation to publicly disclose most incoming or ongoing shortages. ASA will continue to work with government agencies to help find solutions to address drug shortages and preserve patient access to safe care.  

Click here to read ASA’s full comment letter.  

Click here to see the FDA’s guidance document.