EpiPen Ad By Pfizer Nets Warning Letter

EpiPen Ad By Pfizer Nets Warning Letter

June 6th, 2012 // 1:11 pm @ jmpickett

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In a bit of hyperbole, a television ad created to promote the EpiPen emergency treatment for allergic reactions suggested a quick jab is all that a little boy named Jake would need to fend off any unexpected and threatening foods at a friend’s birthday party. In the ad, his mom says to him: “Even with your peanut allergy and a cake made of who-knows-what… we’re prepared… with EpiPen.”

But as the FDA pointed out in a recent warning letter: if only it were that easy. In reality, EpiPen is intended for immediate self-administration as emergency supportive therapy and immediate medical care may be needed after use. It is not at all clear from the ad that ‘Jake,’ who looks to be about five years old, is capable of administering EpiPen in the event of an emergency. Or maybe Mom is sticking around for the festivities. Just the same, the FDA charges the ad creates a false sense of reassurance, since EpiPen is associated with several serious risks and the ad notes that EpiPen cannot eliminate the risk of anaphylaxis.

“The overwhelming impression conveyed by this presentation in the TV ad is that EpiPen alone can provide assurance that a child who has a history of life-threatening allergic reactions does not need to worry or take precautionary measures to avoid exposure to allergens,” the agency writes in a May 24 warning letter to Pfizer, which makes EpiPen, but licenses the device to a unit of Mylan Laboratories. The ad was submitted to the FDA as part of its Bad Ad program, which seeks to encourage people to alert the agency to problematic promotions (read here).

The “TV ad misleadingly suggests that a child who has a peanut allergy can take a chance eating a piece of birthday cake with unknown ingredients and feel completely free from worry about any potential risk of anaphylaxis if prepared with EpiPen. This claim is misleading because it implies that EpiPen alone obviates the need for taking precautionary measures and provides protection against any potential risks due to exposure to an allergen, when this has not been demonstrated by substantial evidence or substantial clinical experience” (here is the warning letter and the ad).

A Pfizer spokesman writes us to say that the TV ad has been discontinued and both drugmakers are “working” with the FDA to address agency concerns. “We recognize the seriousness of anaphylaxis and the importance of awareness and providing appropriate information,” he adds. We are awaiting word from Mylan and will update you accordingly.

Meanwhile, one expert says the ad was not the brightest bit of promotion. “For what little it may be worth, this has to be one of the dumbest ads ever created from a legal/regulatory or common sense standpoint. Did anyone in Mylan legal or regulatory review this ad? If so, what were they smoking, as I’d like some,” writes Arnie Friede, a former FDA associate chief counsel and a former senior corporate counsel at Pfizer, in an e-mail to us.

“Any rational thinking person would know that the way to avoid an allergic reaction is not to eat the problematic food to begin with instead of eating it and then rescuing yourself with an EpiPen. I mean, come on, people. Get real. Could somebody really believe this was a compliant ad, despite the disclosure? Wow!” In other words, relying on EpiPen is not a substitute for checking food that is served.

For those of you wondering why the FDA addressed the letter to Pfizer, instead of Mylan, the likely answer is that Pfizer holds the New Drug Application, according to Friede. “What is the legal basis for sending a Warning Letter to a contract manufacturer’s parent company who, from all we know, had no responsibility or involvement in the preparation of the ad in question?” Friede ponders. “Is FDA saying that a contract manufacturer, or a product licensor, can never delegate its duties to comply with the FD&C Act? That is not a correct statement of the law.”

A Pfizer spokesman confirms that the letter was received because the drugmaker holds the NDA. We asked the FDA to explain its decision, but have not yet heard ba