Drugs

Pfizer’s Adcetris Social Media Ads are Misleading: FDA

FDA has cited Pfizer over social media promotions for its cancer drug Adcetris, stating that certain Facebook advertisements are “false or misleading” and violate federal law. In a just-posted letter to Pfizer, CDER Office of Prescription Drug Promotion says a series of ads promoting Adcetris misrepresented the drug’s approved use and failed to adequately disclose key safety risks.

According to FDA, the ads suggested Adcetris could be used broadly for T-cell lymphoma, including statements such as “Adcetris plus CHP is an FDA-approved option for adults with certain CD30-expressing T-cell lymphomas.” However, the agency says the promotions omitted critical details about the drug’s specific approved indication, which is limited to certain subtypes of peripheral T-cell lymphoma, including systemic anaplastic large cell lymphoma.

“The presentation of this information is not sufficient to correct the overall misleading impression,” the FDA writes, noting that more complete indication language appeared only in less prominent portions of the ads.

Regulators also say the Facebook promotions failed to include important safety information, including a contraindication against use with the chemotherapy agent bleomycin due to risk of pulmonary toxicity. The agency further cites omissions related to serious and potentially fatal risks, including infections, severe skin reactions such as Stevens-Johnson syndrome, and hyperglycemia.

By excluding these details, FDA says the ads minimized the drug’s risks and created a misleading impression of its safety profile.

The agency concludes that the materials “misbrand” Adcetris under the Federal Food, Drug, and Cosmetic Act and requested that Pfizer take immediate action, including ceasing the distribution of the problematic advertisements.

Pfizer has been asked to respond within 15 working days, outlining steps to address the violations and identifying any additional promotional materials that may contain similar claims. The company may also provide justification if it believes the materials comply with federal regulations.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome