Editorial: We Disagree with the Petition to Make Epinephrine an OTC Drug

Dillon Mueller’s story is a horrific tragedy. The 18 year-old Wisconsinite perished in 2014 from an anaphylactic reaction caused by a bee sting despite never having been diagnosed with an allergy. We extend our deepest sympathies to his family and encourage you to read about Dillon on the website his parents, Angel and George Mueller, established to memorialize him.

Because he was never diagnosed with an allergy, Dillon was never prescribed epinephrine, so there was no auto-injector on-hand to administer the only drug that might have saved his life.

In an effort to foster much needed change, the Muellers have started a petition urging the FDA to designate epinephrine an “Over the Counter” (OTC) drug, i.e. one that is readily available without a prescription. The premise of the petition is that more people would carry epinephrine if it was available without a prescription, and more people carrying would imply a greater chance of epinephrine being available when a victim suffering anaphylaxis isn’t carrying his own.

While we appreciate the Muellers’ efforts to help prevent others from suffering the same fate as Dillon’s, we believe this effort is misguided.

Epinephrine auto-injectors are expensive (costing hundreds of dollars) with a relatively short time-to-expiration (generally 12 months or less.)  As such, we do not believe many people would purchase the drug unless they were directed to do so by a physician. If they were to do so, administering the drug to someone else in an emergency might actually expose them to litigation due to the present tort laws of many jurisdictions.

We are also concerned that, once given OTC designation, epinephrine would cease to be covered by many insurers, leaving even more families to struggle with the high costs of the medication.

Instead, we support legislation that mandates stock epinephrine in ambulances and all places of public accommodation, like restaurants, cafeterias, malls, movie theaters – everywhere you currently find cardiac defibrillator AEDs. Such legislation should also include the necessary Good Samaritan provisions to shield those who administer the drug in good faith from litigation, and provide the funding to stock and replenish the drug and support training in proper administration, much like CPR training is readily available today.

We believe this would be a much more effective and deterministic way to achieve the Muellers’ goal – that of extending the safety net of epinephrine availability – so that Dillon’s story is not repeated.

What do you think? Let us know by commenting below.

Note of disclosure: Mylan is an advertiser with SnackSafely.com
Print or share this article
Click to visit sponsor