For Immediate Release - November 07, 2013

Pfizer and Mylan to Pay Massachusetts $625,000 Over TV Advertisement for EpiPen

Companies Required to Submit Future EpiPen Ad Campaigns to FDA for Review

BOSTON – The manufacturer and marketer for EpiPen, a mobile device used to treat acute allergic reactions, will pay Massachusetts a total of $625,000 to settle allegations of running a deceptive television advertisement overstating the effectiveness of the product, Attorney General Martha Coakley announced today.

In separate consent judgments, filed today in Suffolk Superior Court, Pfizer Inc. (Pfizer), and Mylan Specialty, L.P. (Mylan), are required to submit new ad campaigns for EpiPen and EpiPen Jr. auto-injectors to the U.S. Food and Drug Administration (FDA) for pre-review. Pfizer manufactures EpiPen and Mylan markets EpiPen under a license agreement with Pfizer.

“While EpiPen is an important medication that can provide emergency assistance for severe allergic reactions, these advertisements put consumers at risk by giving an overall misleading impression that the product alone removes the need to take precautionary measures,” AG Coakley said. “We are pleased that these settlements will bring money back to assist consumers in Massachusetts and prevent these deceptive ads from running again.”

The AG’s investigation into the practices of Pfizer and Mylan, concerning a 60-second advertisement televised in April 2012, titled “Max’s Birthday Party,” revealed that the ad misled consumers into believing that EpiPen alone can prevent allergic reactions. The TV ad ran 170 times over one week, and a similar print advertisement ran in eight different magazine issues, which sold millions of copies nationwide. The TV ad shows a young mother driving in the car with her son in the backseat. She says, “Excited for Max’s birthday party?  Should be pretty awesome . . . Even with your peanut allergy and a cake made of who-knows-what . . .  Because we’re prepared, right Jake?  . . With EpiPen.” 

After an outcry among parents and allergy advocacy groups, the companies pulled the advertisement. The deceptive commercial also resulted in a warning letter from the FDA concluding that the ad was “false and misleading because it overstates the efficacy of the drug product.”

EpiPen is a self-administered injection of epinephrine, which is a steroid approved by the FDA for emergency treatment of allergic reactions. As the product label states, EpiPen is “intended for immediate self-administration as emergency supportive therapy only and [is] not a substitute for immediate medical care.”

The FDA concluded that the advertisement gave the impression 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.”

Under the consent judgments, the companies will pay $625,000 collectively. Mylan will pay $250,000 to the Commonwealth, including $75,000 in civil penalties, costs, and fees, and $175,000 to fund healthcare consumer protection initiatives. Pfizer will pay $375,000 to the Commonwealth, including $150,000 in civil penalties, costs and fees, and $225,000 to fund healthcare consumer protection initiatives.

Both Pfizer and Mylan cooperated with the AG’s investigation. The AG conducted its investigation of Mylan in coordination with the Oregon Department of Justice, which reached an agreement with Pfizer in December 2012 over similar deceptive advertising allegations.

The investigation and settlement were handled by Assistant Attorney General Eric Gold and Assistant Attorney General Courtney Aladro, both of the Attorney General’s Health Care Division.

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