|Footnotes for this article are available at the end of this page.
Channeling Joe Jackson’s 1982 catchy hit, “Steppin’ Out,” the National Advertising Division (“NAD”) of the BBB National Programs recently released a decision regarding a prescription drug advertisement, resulting in the company pulling a claim from its direct-to-consumer (“DTC”) ad.1 The NAD commonly publishes decisions regarding challenges to various other FDA-regulated product claims from cosmetic and over-the-counter drug companies, but it is not typical for the NAD to issue a decision concerning a prescription drug product promotion.
- One prescription drug company complained to the NAD regarding a competitor’s DTC ad for a breast cancer product.
- The competitor’s DTC ad claimed that its product was the “only drug in class with consistently proven survival benefit in HR+/HER2- metastatic breast cancer . . . across three phase III trials,” which the NAD deemed competitive. The NAD reasoned that this statement would lead consumers to believe that patients would live longer with this product, determining that this population “lack[s] the medical knowledge or experience to understand nuances in clinical trial design or outcomes.” In addition, the NAD said that the clinical trials referenced were not similar enough for comparison purposes.
- In contrast, the NAD found acceptable a similar statement presented in an ad for the product facing healthcare professionals (“HCPs”), which claimed that the product was “the only CDK4/6 inhibitor with statistically significant overall survival proven across three phase III trials.” The NAD found this claim to be reasonable in context because HCPs are considered to be a more sophisticated audience than consumers, and better able to understand clinical trial data conclusions.
- Although the NAD decision is not legally binding, the losing party complied by removing the DTC claim from its advertisements.
- Time will tell whether the use of the NAD by a prescription drug company is an anomaly or the beginning of a trend.
- NAD challenges offer an alternative (often faster and less expensive) pathway for companies, consumers, or non-governmental organizations to challenge advertisers who otherwise may send in complaints to a government agency or consider litigation.
- While the NAD is not a government agency, and it does not issue civil monetary penalties for its decisions or utilize enforcement tools, such as seeking court action, it may refer a matter to the appropriate government agency for further review if a company chooses not to comply with its decision.
- Whether the advertisement is going to be scrutinized by FDA, the NAD, or a competitor, an important takeaway from this recent decision is that context matters (e.g., DTC vs. HCP). A company must consider the intended audience for its promotional messaging.
- It looks like companies, and the NAD, are “Steppin’ Out” and considering new ways of reviewing (and challenging) prescription drug promotion.
 The NAD’s decision summary can be found here: https://bbbprograms.org/media-center/dd/novartis-Kisqali. The BBB National Programs are a non-profit organization, not operating under any government agency. The NAD operates as an independent party for industry self-regulation, seeking to build consumer trust in advertising and support fair competition in the marketplace. The NAD assesses the truth and accuracy of claims made in national advertising brought to its attention either via competitor challenges or through its own monitoring efforts. The NAD has evaluated claims of many FDA-regulated products.