Drugs

Petition Seeks Ban on Music in DTC Ads

A citizen petition from two groups and three individuals is asking FDA to ban music in direct-to-consumer (DTC) television, radio and internet streamed advertisements because it distracts the audience’s attention from product side effects and contraindications. Filed by Knowledge Ecology International, the Center for Digital Democracy, and three individuals, including Emory Law School professor Liza Vertinsky and Yale Medical School fellow Reshma Ramachandran, the petition urges the agency to specifically ban music from the sections of direct to consumer advertisements that address side effects and risks.

The petition argues that there is a “growing body of literature” that criticizes DTC advertisements for being designed in ways that use “visuals and sound to enhance the impression of health benefits, while using images and sounds to systematically distract attention from the side effects and contraindications.” It focuses on background music and how it works as a distraction to the presentation of risks and “therefore is in conflict with the FDA’s fair balance provision and should be banned,” the petitioners say.

“Whether attention-gaining music enhances or distracts from processing may therefore depend on the consistency of meaning conveyed by the music and verbal message,” the petition contends. “This incongruence between music and message is highly prevalent in television drug commercials. According to the FDA, DTC drug commercials must present a balance of the benefit and risk; however, the background music chosen for most drug commercials often distracts from the risks by being incongruent with its messaging.”

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