Pfizer rebuked by FDA for misleading Adcetris ads on Facebook | Fierce Pharma

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 misbrand Adcetris and make 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. Related By failing to adequately communicate the indication for Adcetris, the Facebook ads create a misleading impression about the drug’s approval
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