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# Think Like a Consumer on DTC Ads: Attorneys
- URL: https://www.fdaweb.com/think-like-a-consumer-on-dtc-ads-attorneys/
- Published: 2024-02-06T12:00:00.000Z
- Updated: 2026-09-14T14:22:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156297

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](mailto:https://www.natlawreview.com/article/fdas-office-prescription-drug-promotion-issues-its-first-untitled-letter-year), the attorneys say the agency [letter](https://www.fdaweb.com/opdp-letter-cites-novartis-on-kisqali-ad/) 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*](mailto:https://www.fda.gov/media/102575/download) (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.”