The FDA has scolded Pfizer over Facebook ads for the cancer drug Adcetris, accusing the Big Pharma of failing to adequately communicate the indication, contraindications and risks.
Continuing a wave of actions against drug ads in recent weeks, the FDA sent (PDF) Pfizer an untitled letter outlining its issues with promotional materials for the CD30-directed antibody-drug conjugate Adcetris. The FDA ruled the Facebook ads misbranded Adcetris and made distributing the drug a violation of the Federal Food, Drug and Cosmetic Act.
FDA officials found fault with video ads that made statements such as: “Recently diagnosed with T-cell lymphoma?” and: “A new T-cell lymphoma diagnosis brings many questions.” In the FDA’s view, the claims suggest Adcetris is approved for the general treatment of T-cell lymphoma.
One of the video ads clarified that Adcetris is authorized for adults with certain CD30-expressing T-cell lymphomas, but that too fell short of the FDA’s desired level of specificity. Adcetris is indicated for use in adults with previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas in combination with cyclophosphamide, doxorubicin and prednisone.
By failing to adequately communicate the indication for Adcetris, the Facebook ads create a misleading impression about the drug’s approval, the FDA said. The agency acknowledged that the full indication is shown at the bottom of the ads, but concluded the information failed to correct “the overall misleading impression created by these claims.”
The FDA also found the ads misled viewers by omitting risk information about a contraindication with concomitant bleomycin because of pulmonary toxicity and by failing to disclose fatal outcomes. Omitting the material information minimized Adcetris’ risks and created a misleading impression of the drug’s safety, the FDA said.
FDA officials, who sent the letter on April 8, gave Pfizer 15 working days to explain its plan for stopping the ads. Pfizer received (PDF) a similar request in September, when the FDA included a critique of a TV ad for the ulcerative colitis drug Velsipity in its first batch of untitled letters.
The September batch of untitled letters marked the start of a significant escalation of the enforcement of drug advertising rules. Last week’s Adcetris notice was the 72nd untitled letter published by the FDA since September. Before that, the agency had issued 35 untitled letters in 12 years.