The United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent an Untitled Letter to Kaleo, Inc., regarding a social media post made by an influencer for its epinephrine injectable, Auvi-Q. The post was made by an NFL wife on her personal Instagram account with the notation that it was a “[p]aid partnership with auvi-q.”
Auvi-Q is for the emergency treatment of allergic reactions, including anaphylaxis to stinging insects, biting insects, allergen immunotherapy, foods, drugs, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. It is intended for immediate self-administration and is not a substitute for immediate medical care. The Prescribing Information for the drug cites warnings and precautions, including the possibility of serious infections at the injection site and allergic reactions associated with sulfite, among others.
In the Instagram post at issue, the influencer made the following claims, “So, I have an infant and a toddler both who have severe food allergies . . . . Based on my experience, I can tell you that a severe reaction may not look how you think it should look. So, after the diagnosis, a big part of the plan was going to my pediatrician, and he did prescribe me Auvi-Q. Auvi-Q is the only epinephrine autoinjector out there for infants and toddlers” and “AUVI-q® (epinephrine injection, USP) is for life-threatening allergic emergencies.”
FDA OPDP states that the post is misleading because it presents efficacy claims for Auvi-Q but does not communicate any risk information. While the post does state, “For Important Safety Information, visit @auviq_ISI[,]” OPDP finds that the inclusion of that statement “does not mitigate the misleading impression created by the omission of risk information.” OPDP goes on to say, “by omitting the risks associated with Auvi-Q, the post fails to provide material information about the consequences that may result from the use of Auvi-Q and creates a misleading impression about the drug’s safety.”
To resolve the issue, OPDP requested a written response to the letter that includes a list of all promotional communications for Auvi-Q that contain representations similar to those at issue in the letter and explain a plan for the “timely discontinuation of such communications, or for ceasing distribution of Auvi-Q.”