FARE Update on National Shortage of Epinephrine Auto-Injectors

If you have had trouble purchasing an epinephrine auto-injector because of the shortage, please let us know in this survey.

FARE continues to monitor a national shortage of epinephrine auto-injectors that was first declared in May following our letter to Food and Drug Administration (FDA) Commissioner Scott Gottlieb.

The shortage continues to affect two of the three manufacturers of epinephrine auto-injectors (EAIs) currently on the market: Amneal (formerly Impax, generic of Adrenaclick®), and Mylan Specialty (EpiPen®, EpiPen® Jr, and their generics). The only product that is not currently in shortage is made by kaléo (Auvi-Q®). Note: To allow for greater options and access, call your insurance company and urge them to add Auvi-Q to the list of covered drugs.

As students go back to school, parents of children with food allergies face added uncertainty about access to, and affordability of, EAIs.

What we know:

The manufacturer reports that EpiPens are in production, but behind schedule.

For that reason, please don’t stockpile extra EpiPens if you have enough of them. If some people obtain more than they need, other patients won’t get any… making the problem worse, not better.

The manufacturer states that they’re “expedit[ing] shipments as rapidly as possible,” but also says they “can’t guarantee availability at all pharmacies.” Supplies vary from pharmacy to pharmacy and usually depend on the type of pharmacy it is. If you can’t find your EAI at a local CVS or Walgreens, you can try another store within the same chain but might have more success visiting the grocery store or an independent pharmacy. A list of independent pharmacies is at www.healthmart.com.

FARE has called upon the FDA to use all of the tools it has to end the shortage. FDA has declared a national shortage, and is permitting certain practices – such as the release of Amneal’s product in batches with known quality problems like “discolored (pinkish or brown color), cloudy, or contains particles” -- in response to the shortage. (If you are dispensed an EAI that looks like this, do not use it and return it to your pharmacy for replacement.) In absence of a current epinephrine auto-injector, patients may use an expired dose but should call 911 and receive medical treatment.

FARE has called on FDA to permit importation of approved EAIs from other developed countries, and Alex Azar, Secretary of Health and Human Services, recently stated an intention to explore this option.

Over the long term, FARE’s advocacy priorities include continuing to urge the FDA to approve new options for patients, which will increase competition in the market. The agency released a “Draft Guidance on Epinephrine” in July, and the agency is working with several companies that are developing new epinephrine auto-injectors.