In May of 2012, I advised that a tv commercial launched by Mylan was misleading and dangerous. It was the Max’s Birthday Party campaign, which caused serious concern within the allergic community. The script read:
Mom: So you’re excited for Max’s birthday party? It should be pretty awesome.
Mom: Even with your peanut allergy and a cake made from who knows what, because we’re prepared, right James?
Mom: With EpiPen.
The commercial showed James being dropped off for the party, His Mom hands over an EpiPen as the camera sweeps over a table full of food and James runs off to play. The voice over advises to seek emergency medical attention immediately after using an EpiPen, which is followed by product information, contraindications, and side effects.
The scene switches to James being picked up by his Mom and leaving the party. The voice over says: You can’t be everywhere your child’s allergens are, but you can be prepared. Ask you health care professional if EpiPen or EpiPen Junior is right for you or your child. Visit epipen.com for more information. For an excellent series of screen shots along with the script and storyboard, click here.
As a lawyer, I felt that the commercial exposed Mylan to liability for implying that you can safely eat foods that may contain your allergens, as long as you have an EpiPen. What should have been made clear is that strict avoidance of your food allergens, even in trace amounts, is the only line of defense in preventing a food allergic reaction. While EpiPens are the appropriate treatment for a reaction, reactions can still be fatal, even if you use an EpiPen. Every effort must be made to avoid this medical emergency, and strict avoidance of your allergen is the only way to prevent a reaction.
I later found out that The Office of Prescription Drug Promotion (OPDP), Division of Consumer Drug Promotion (DCDP) of the U.S. Food and Drug Administration (FDA) sent a warning letter to Pfizer/Mylan over these EpiPen ads. A conference call between Pfizer and The Office of Prescription Drug Promotion occurred on April 20, 2012 in response to the Max’s Birthday Party ad campaign, and the ads were pulled. For the details, click here.
Mylan released a disclaimer commercial in January of 2013. The dialogue from the disclaimer commercial is:
Mom: You may have seen an EpiPen commercial that created the impression that a child who has peanut allergies can eat cake with unknown ingredients and be worry free from the risk of anaphylaxis, if prepared with EpiPen. The FDA said this was misleading and asked us to clarify. EpiPen cannot prevent an allergic reaction. The most important step is to avoid your allergen all together. If a reaction happens, use EpiPen right away, and immediately seek emergency treatment.
News broke quietly last week that Mylan must now submit commercials prior to airing to the FDA, and that Mylan settled with the State Attorney for Oregon, Ellen Rosenblum, for “misleading EpiPen advertisements” and will pay $250,000 to the state of Oregon. Mylan denies any wrong doing.
Ms. Rosenblum stated that Mylan went overboard in its national tv commercial by telling parents that with EpiPens, they need not worry about their children being exposed to potentially deadly allergens and that “Mylan was extremely irresponsible to suggest to parents that EpiPen is a substitute for vigilantly avoiding their children’s allergens. Our resolution of this case ensures that consumers will understand the limitations of EpiPen as well as its approved uses.” She is also considering a related investigation against Mylan’s EpiPen marketing.
Mylan also entered into a consent judgment with the state of Massachusetts. Attorney General Martha Coakley stated that Mylan’s campaign was deceptive as it gave the impression that the product alone removes the need to take precautionary measures. To Massachusetts, Mylan as manufacturer will pay $250,000 including $75,000 in costs, fees, and civil penalties and $175,000 to fund health care consumer protection initiatives. Pfizer Drug Company as marketer will pay $375,000 to the state, including $150,000 in civil penalties, fees and costs and $225,000 to fund health care consumer protection initiatives.
I have had sporadic contact with the senior brand manager for EpiPen at Pfizer. We spoke about my dislike of most of his commercials, and I was surprised that most of the concerns I pointed out were not intended. He simply did not realize what I easily picked up, I think because he doesn’t care for someone with food allergies.
Perhaps Mylan and Pfizer should consult with allergy bloggers who focus on safety issues before they write their next campaign. It could save them about a million dollars, and I know several people who would be happy to help out.
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