Drugs

Bayer DTC Materials Run Afoul of FDA

FDA has issued an untitled letter to Bayer HealthCare Pharmaceuticals, citing misleading direct-to-consumer advertising for its prostate cancer drug Nubeqa. In the letter, FDA’s Office of Prescription Drug Promotion said a YouTube video and a Spanish-language television advertisement for Nubeqa omit key safety information and fail to present risk disclosures in a manner consistent with regulatory requirements.

According to FDA, the promotional pieces emphasize the drug’s benefits while inadequately conveying the seriousness of potential adverse events. Although the ads include a general statement that Nubeqa “may cause serious side effects, including heart disease and seizure,” the agency said they omit critical details from the FDA-approved patient information.

Specifically, FDA noted that the ads do not adequately disclose that ischemic heart disease associated with the drug can be fatal or that seizures may require patients to avoid activities where sudden loss of consciousness could pose a risk to themselves or others. The omission of these details creates a misleading impression about the drug’s safety profile, the agency said.

The letter also highlights technical deficiencies in how risk information is presented. FDA found that the ads fail to meet “dual modality” requirements, meaning that key risk information conveyed in audio is not simultaneously presented in text. In addition, the agency said the use of fast-paced visuals, frequent scene changes, and attention-grabbing graphics during the major statement interferes with viewers’ ability to comprehend risk information.

FDA has asked Bayer to cease dissemination of the violative materials and to respond within 15 working days, outlining steps to address the issues and identifying other promotional communications that may contain similar deficiencies.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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