Drugs

FDA Rebukes Novartis Over Misleading TV Ad

FDA has issued Novartis Pharmaceuticals an untitled letter citing the company’s allegedly false or misleading direct-to-consumer television advertisement for Fabhalta (iptacopan), saying the ad downplays serious safety risks and exaggerates the drug’s benefits. Fabhalta, approved 12/2023, is a twice-daily oral treatment for paroxysmal nocturnal hemoglobinuria, a rare and life-threatening blood disorder. It carries a boxed warning about the risk of serious infections.

CDER’s Office of Prescription Drug Promotion said the commercial misbrands Fabhalta and faulted the ad for distracting viewers from Fabhalta’s boxed warning of life-threatening infections by interweaving the disclosure with a “romantic story arc” in which a man meets and later dates a woman. FDA said the shifting scenes, background music, and emotional narrative undermined comprehension of the drug’s safety risks.

Additionally, the ad claimed that Fabhalta “substantially improved hemoglobin levels compared to Soliris or Ultomiris infusions,” but FDA’s letter said the supporting data were presented in a way that most viewers could not process.

FDA directed Novartis to respond within 15 business days with plans to discontinue or correct the ad and to provide a list of other promotional materials containing similar representations.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

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