FDA Policy/General

FDA Declines to Ban Some Music in DTC Ads

FDA is declining to take the action sought in an 8/3/2020 petition from Knowledge Ecology International to ban all music during the presentation of risk information in direct-to-consumer ads. In its response, the agency says its current approach includes the assessment of background music in ads, where present, as part of determining whether the risk information in a specific ad is communicated effectively in light of all of the elements used in the particular ad.

The response also references a newly promulgated final regulation that will “add to existing regulatory provisions to help ensure that the major statement relating to side effects and contraindications of the advertised drug is presented in a clear, conspicuous, and neutral manner.”

The letter says FDA believes that the best course of action at this time is to continue the approach in longstanding regulations that considers all of the elements in each specific ad to determine whether risk information is communicated effectively, without a total ban on background music or any other particular element.

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