FDA rebukes Pfizer over misleading Adcetris social media ads

The US Food and Drug Administration has criticised Pfizer over Facebook advertisements for its cancer therapy Adcetris, saying the campaign failed to adequately communicate the drug’s approved use and safety risks.

In an untitled letter, the regulator said the ads created a misleading impression that Adcetris is broadly approved for T-cell lymphoma, rather than for specific CD30-expressing subtypes in combination with other treatments. While fuller details were included in small print, the FDA said these did not correct the overall message.

The agency also raised concerns over the omission of key risk information, including a contraindication with bleomycin and the potential for fatal outcomes, arguing the ads understated safety risks.

Pfizer has been given 15 working days to respond and outline corrective action. The warning forms part of a broader crackdown on pharmaceutical advertising, with the FDA sharply increasing enforcement activity in recent months.