Ensuring Access to Lifesaving Drugs Act of 2023

HR 3793, the Ensuring Access to Lifesaving Drugs Act of 2023, requires manufacturers of critical drugs to extend expiration dates by submitting stability data to the FDA. It directly affects manufacturers of "life-saving drugs," defined as those treating life-threatening conditions, preventing disease, or critical during public health emergencies (like medical countermeasures or drugs on shortage lists). The bill authorizes the FDA to order manufacturers to conduct studies, submit data, and update labeling for longer expiration dates based on that data. Violations carry daily civil penalties up to $10,000, ensuring manufacturers comply with extended dating for essential medications.