FDA's Office of Prescription Drug Promotion issued a warning letter
to Mylan and Pfizer for an EpiPen TV ad that the agency said hyped the effectiveness of the drug.
The agency's Bad Ad program received a complaint about the 60-second ad, entitled “Max's Birthday Party.” The ad, for EpiPen and EpiPen Jr. Auto-Injectors, depicts a sardonic mom and her son driving to a birthday party. “Excited for Max's birthday party? Should be pretty awesome,” says mom. “Even with your peanut allergy and a cake made of who knows what!” – because, she adds, they're prepared, with EpiPen.
And while superimposed text notes that the drug/device combo “can't eliminate the risk of anaphylaxis,” agency reviewers said everything else in the spot suggests the exact opposite. “Specifically, 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” and that the product “alone obviates the need for taking precautionary measures and provides protection against any potential risks due to exposure to an allergen.”
The May 24 warning letter said Pfizer agreed to pull the ad in a teleconference with OPDP on April 20. The agency demanded that Pfizer present, in writing, a list of all promotional materials making similar claims and submit “corrective messages” to the same audience, using the same media, duration of time and frequency “to the extent possible.”
OPDP also posted an untitled letter sent to Vertex this week. That letter, dated May 25, concerns an as-yet un-disseminated “branded story” for HCV drug Incivek that the agency said “overstates the efficacy, omits material facts and minimizes important risk information about the drug product.” The agency said, more or less, that the promotion, a testimonial by a man whose HCV infection was successfully treated with Incivek, presented a best case scenario and could misleadingly inflate patient expectations of the treatment.
Reviewers also took issue with the use of the term “cleared,” noting that “patients with undetectable HCV_RNA levels after therapy may still have replication competent virus,” and said the materials minimized risk by suggesting that “rash is not a serious side effect,” noting that some skin reactions related to the treatment can require hospitalization.