FDA Policy/General

Think Like a Consumer on DTC Ads: Attorneys

Three SheppardMullin attorneys say a recent CDER Office of Prescription Drug Promotion (OPDP) untitled letter to Novartis alleging that a direct-to-consumer (DTC) TV ad for its breast cancer drug Kisqali (ribociclib) made false or misleading efficacy representations is a good reminder that those working on such ads should put themselves in the shoes of a consumer. Writing in an online National Law Review post, the attorneys say the agency letter was the first issued by OPDP in 2024 and demonstrates how OPDP is looking at the continued relevance of the 2023 guidance on Medical Product Communications That Are Consistent With the Required Labeling: Questions and Answers (CWL guidance).

The post says the Kisqali letter “keys on several concepts from the CWL guidance and the use of DTC claims based upon data that is not contained in the product prescribing information but is nevertheless consistent with it…. All in all, this letter suggests that FDA is looking very closely at not just the disclaimer, but the claim language that goes along with the description of data. This letter provides yet another example of how OPDP will continue to apply the CWL guidance to ensure that efficacy claims are consistent with the approved product labeling.”

Since OPDP can be expected to continue to closely monitor DTC promotional advertising in broadcast and social media, the attorneys conclude, manufacturers should remember to “step into the shoes of the consumer when developing promotional materials, and to consider not only the impact of one claim in isolation, but the overall impression created by the entire presentation, with a goal of helping consumers to be better informed about their healthcare decisions.”

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