On June 4, 2024, the National Advertising Division (“NAD”), a self-regulatory forum for competitive advertising disputes, recommended that a breast cancer genomic test manufacturer (“Advertiser”) modify or discontinue several claims regarding the superiority of its tests for Black women, including claims that a competitor’s (“Challenger”) test is “inappropriate for women and that it is biased, inaccurate, and inconsistent.”
The Advertiser and the Challenger are both manufacturers of prognostic genomic tests that assess the risk of recurrence in early-stage breast cancer patients. Between 2021 and 2023, the Advertiser made a series of claims on its website, in social media posts and in sponsored advertising content distributed to health care providers, asserting the superiority of its test for detecting high-risk breast cancer in Black women. Specifically, the Advertiser claimed, among other things, that:
“FACT: … uncovers bias seen in other genomic tests.”
“Only [] & [] results identify higher risk ER+ tumors in Black women.”
“… test has a lower prognostic accuracy in Black women.”
“Faster, more accurate predictions.”
“… provides more consistent results for Black women than other gene profiling tests.”
“… provides more consistent results for Black women with early-stage breast cancer.”
We provide some highlights from the NAD’s decision below.
Standard of Review
Generally, advertisers must have a “reasonable basis” for claims disseminated in advertising. As noted by the NAD, what constitutes a “reasonable basis” “depends on several factors, including the type of product, the type of claim, the consumer benefit from a truthful claim, the ease of developing substantiation for the claim, the consequences of a false claim and the amount of substantiation experts in the field believe is reasonable.”
In this case, all of the Advertiser’s claims were health claims, which should be supported by “competent and reliable scientific evidence, as defined by the [Federal Trade Commission]”(“FTC”). The FTC defines this standard as “tests, analyses, research, or studies that (1) have been conducted and evaluated in an objective manner by experts in the relevant disease, condition, or function to which the representation relates; and (2) are generally accepted in the profession to yield accurate and reliable results.”
When advertisers rely on studies to support health-related claims, they must ensure that the study is competent and reliable, and that the study results relate to the specific benefits being claimed. Therefore, “[c]laims must be narrowly tailored so that there is a good fit between the advertiser’s substantiation and the messages conveyed to consumers by the advertising.” This is critical to ensure that consumers have accurate information about the health products they purchase and use.
Advertiser’s Superiority/Comparative Claims Were Not Adequately Substantiated
The Advertiser claimed that its test was the “only” test that could “identify higher risk ER+ tumors in Black women.” The NAD determined that this claim, which was disseminated to health care providers on a two-sided postcard, reasonably conveyed the message that “scientific evidence establishes that with respect to Black women, only […] tests are capable of identifying and distinguishing ER+ (which have higher risk and worse outcomes) from other types of tumors.” The NAD found these explicit claims also implicitly conveyed the message that Black women would suffer worse health outcomes if they relied on the Challenger’s test.
In support of its claims, the Advertiser relied on two studies:
- A 2022 study that found ER+ Basal-type breast cancer occurs more frequently in Black patients and results in worse outcomes; and
- A 2019 study demonstrated that the Advertiser’s test was “able to identify patients with hormone receptor-positive tumors with low sensitivity to chemotherapy and good outcome, irrespective of race.” This suggested that the test could be helpful “in characterizing the tumor’s biology and selecting patients who will not benefit from chemotherapy independently of their ancestry.”
After reviewing the studies, the NAD found that they supported the conclusion that there is a higher incidence of ER+ Basal (a high-risk form of cancer) in Black women as compared to white women. However, the evidence did not “provide a reasonable basis for the overly broad message conveyed by the challenged claim.” As a result, the NAD “recommended that the Advertiser either discontinue the claim ‘only […] results can identify higher risk ER+ tumors in Black women’ or modify it to more accurately reflect the underlying support (i.e., that […] testing can identify the clinical subset of ER+ tumors that are Basal-type, which occur more frequently in Black patients and exhibit worse outcomes compared to Luminal tumors).”
The Challenger also took issue with several videos and social media posts directed at breast cancer patients questioning why anyone would rely on the results of the Challenger’s tests and characterizing the test as having a “lower accuracy in Black women and not providing consistent results.” The NAD determined that these claims did not accurately reflect the findings of the scientific studies relied on by the Advertiser.
For example, the Advertiser cited a 2021 study comparing results by the Advertiser and Challenger’s tests when performed on the same Black women, which found 62% of Black women who were given a low RS by the Challenger’s test received a high RS from the Advertiser’s test. However, while there was a clear discordance in the test results, the NAD noted that the study in question did not include any clinical outcome data, meaning there was no evidence indicating which test was more accurate. Likewise, the Advertiser relied on a 2019 study demonstrating the effectiveness of its test in identifying patients with these high-risk tumors. However, while the NAD acknowledged the study supported claims regarding the accuracy of the Advertiser’s test, the NAD emphasized the lack of any evidence suggesting the Advertiser’s test is “more” accurate than the Challenger’s test or that Black women would suffer worse health outcomes if they relied on the Challenger’s test.
The NAD concluded the Advertiser’s claims were unsubstantiated because they overstated the findings of the scientific studies they relied on. The NAD also noted that in order to reach a definitive conclusion regarding the accuracy of these tests, a prospective head-to-head trial would be needed. Therefore, the NAD recommended that the Advertiser discontinue the challenged claims or modify its messaging to avoid conveying the overly broad message that the Challenger’s test has “lower prognostic accuracy and provides less consistent results for Black women.”
Practical Takeaways
- Medical device companies should consider the possibility of a NAD challenge, particularly when making superiority and/or comparative claims.
- Advertisers making health-related claims must carefully tailor any claims to accurately reflect the relevant science.
- Any superiority or comparative claims about a competitor’s product must be narrowly drawn and must not falsely disparage the competing product. All claims should also be supported by a head-to-head study(ies) when comparing products.
- While the NAD is a voluntary forum, it can refer cases to the FTC and/or Food and Drug Administration for enforcement if a company chooses not to participate or refuses to follow the NAD’s recommendations at the end of the proceeding.
For more information on the advertising and promotion of medical devices, please contact:
- Carolina Wirth at (202) 780-2989 or cwirth@hallrender.com; or
- Your primary Hall Render contact.
Special thanks to Anna Lants, Summer Associate, for her assistance with the preparation of this article.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
