The FDA has reprimanded Pfizer over a Facebook ad for the cancer drug ADCETRIS, accusing the drug giant of failing to properly communicate indications, contraindications and risks.
Continuing a series of actions against drug advertising in recent weeks, the FDA sent an untitled letter to Pfizer (PDF) outlining problems with marketing materials for ADCETRIS, an antibody-drug combination that targets CD30. The FDA ruled that Facebook ads misrepresented the ADCETRIS brand and violated the Federal Food, Drug, and Cosmetic Act by distributing the drug.
FDA officials found flaws in video ads that said things like, “Have you recently been diagnosed with T-cell lymphoma?” And, “The diagnosis of a new T-cell lymphoma raises many questions.” In the FDA’s view, this claim suggests that ADCETRIS is approved for the general treatment of T-cell lymphoma.
One of the video ads revealed that ADCETRIS is approved for adults with certain CD30-expressing T-cell lymphomas, but this also fell short of the level of specificity the FDA desired. ADCETRIS is indicated in combination with cyclophosphamide, doxorubicin, and prednisone in adults with previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphoma.
The FDA said the Facebook ad did not adequately communicate the indication for ADCETRIS and gave a misleading impression of the drug’s approval. The agency acknowledged that the full display was shown at the bottom of the ad, but concluded that the information could not correct the “overall misleading impression created by these claims.”
The FDA also found that the advertisement misled viewers by omitting risk information regarding contraindications to coadministering bleomycin due to pulmonary toxicity and failing to disclose fatal outcomes. Omitting important information minimized the risks of ADCETRIS and created a misleading impression about the drug’s safety, the FDA said.
In an April 8 letter, FDA officials gave Pfizer 15 business days to explain its plans to stop advertising. Pfizer received a similar request in September (PDF), when the FDA included criticism of TV ads for its ulcerative colitis drug Velcipity in the first round of untitled letters.
An untitled letter filed in September marked the beginning of a major expansion in enforcement of drug advertising rules. Last week’s ADCETRIS notice was the 72nd untitled letter issued by the FDA since September. Prior to that, the agency issued 35 untitled letters over a 12-year period.
