Oregon Attorney General Ellen Rosenblum said Thursday that pharmaceutical company Mylan Specialty L.P. has agreed to submit any new TV commercials for EpiPen and EpiPen Jr. to the Food and Drug Administration before airing them to consumers.
Mylan also agreed to address any material FDA comments about the submitted advertisements, and to provide notice to the Oregon Department of Justice if FDA does not comment on the materials.
The agreement also requires Mylan to pay $250,000 to the state of Oregon -- although Mylan denies any wrongdoing.
The settlement concludes DOJ actions taken in response to a national television advertisement that promoted EpiPen products.
Rosenblum alleged that the commercial wrongly suggested that parents who were “prepared with EpiPen” did not need to worry about letting their allergic children eat food with unknown ingredients.
“Severe food allergies are a potentially fatal health risk,” said Rosenblum. “Epinephrine injections can save lives in emergencies, but 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.”
Last December, Pfizer, Inc. agreed to pay Oregon $1 million over Pfizer’s role in the same advertising campaign. Although Pfizer and Mylan had marketed EpiPen jointly, Mylan subsequently obtained Pfizer’s interests in EpiPen products in the United States.
Following the Pfizer settlement, Oregon DOJ learned that the office of Massachusetts Attorney General Martha Coakley was conducting a related investigation regarding Mylan.
Rosenblum thanked Assistant AG David Hart for coordinating with his colleagues in Massachusetts to achieve this excellent result for Oregonians.