The US Food and Drug Administration (FDA) is actively seeking “creative” proposals from pharmaceutical companies to transition epinephrine — the life-saving treatment for severe allergic reactions — from prescription-only to over-the-counter (OTC) status. During a recent workshop, Karen Murry, Director of the Office of Nonprescription Drugs, invited sponsors to discuss how to safely expand access to the drug.
While the move could revolutionize allergy safety, Murry acknowledged significant hurdles. Unlike many OTC medications, epinephrine carries serious risks. “Epinephrine has serious adverse effects, particularly cardiovascular,” Murry noted, adding that the drug is almost always administered in high-stress, life-or-death situations. This environment makes it difficult for users to stop and read the detailed instructions typically found on prescription packaging.
A primary concern is ensuring that a person in the throes of anaphylaxis, or even an untrained bystander, can use the device correctly without prior instruction. “The user might not read the labeling ahead of time, and they must be able to figure it out quickly,” Murry explained. This creates a unique challenge for designers: translating a complex medical label into a simplified “Drug Facts” format that is instantly understandable during an emergency.
To overcome these obstacles, the FDA suggests looking at the successful 2023 OTC switch of naloxone (Narcan). Murry, who led the clinical team for the naloxone project, believes that the strategies used to simplify opioid overdose treatments could serve as a blueprint. “Sponsors interested in developing a non-prescription epinephrine product could potentially use some similar techniques and learnings from non-prescription naloxone development,” she suggested.
However, the comparison isn’t perfect because of the “risk of harm.” If naloxone is given to someone who isn’t actually overdosing, it generally does not hurt them. Epinephrine is different. The FDA is currently weighing the consequences of accidental administration. Murry posed the critical question: “If they believe that they are having an anaphylactic reaction, but they don’t know for sure… what is the likelihood of harm to the person to whom it is administered?”
One potential solution is the “Additional Considerations for Nonprescription Use” (ACNU) pathway. This new regulation allows for “creative approaches” beyond just a paper label. If a company finds that people cannot understand the instructions from the packaging alone, they could propose digital aids or other innovative tools to ensure the drug is used safely. “We think ACNU has great potential to expand non-prescription options across a wide array of therapeutic areas,” Murry affirmed.
Ultimately, the goal is to make life-saving medicine more affordable and accessible. While the FDA does not set drug prices, Murry noted that OTC switches typically drive down costs for both consumers and the healthcare system. While the agency is excited about a potential OTC version, they remain open to any strategy that saves lives. “We’ll consider all potential ways to increase epinephrine access, not just non-prescription,” Murry concluded.
Author’s Note: “Benefits of Epinephrine for Anaphylaxis Outweigh Potential Harm-A Safety Review“ published in the Journal of Allergy and Clinical Immunology clearly states:
Appropriately dosed and administered epinephrine should engender no fear of use for anaphylaxis. The potential harm of delaying or withholding epinephrine treatment for anaphylaxis far outweighs the potential risk of [auto-injectors].
If you suspect anaphylaxis, do not hesitate to administer epinephrine as soon as possible.
