On January 18, 2024, the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued its first enforcement letter of the year. Last year, OPDP did not issue its first enforcement letter until July, as we discussed here, which makes us wonder whether we will see an increase in enforcement this year. As we discussed here, OPDP only issued five letters (four Untitled Letters and one Warning Letter) in 2023, with the majority of the letters being published in the last quarter of the year.
The first Untitled Letter of 2024 was issued to a pharmaceutical company for making false and misleading representations about the efficacy of its metastatic breast cancer oral drug in a direct‑to-consumer (“DTC”) advertisement. OPDP highlighted three concerning claims from the television advertisement (“TV ad”):
- The voiceover stated, “And [the drug product] helps preserve quality of life so you’re not just living, you’re living well.”
- A graphic that stated, “PRESERVES QUALITY OF LIFE.”
- A superimposed text (“SUPER”) stated, “Quality of life was a secondary outcome measure of the trial. At a 26-month check-in, median time to worsening of at least 10% in quality of life score was 27.7 months with KISQALI + letrozole vs 27.6 months with placebo + letrozole. This analysis was not pre-planned to detect a false positive.”
All three claims were supported by data from the company’s clinical trial on the efficacy and safety of the promoted drug product (MONALEESA-2).
False or Misleading Benefit Claims
OPDP found that the “preserves quality of life” and “living well” claims created a misleading impression that the drug product had demonstrated a benefit on the patient-reported outcome (“PRO”) measure of global quality of life (“QoL”). OPDP explained that there were significant limitations to the PRO analysis described in the clinical trial which “preclude the drawing of such conclusions regarding benefits related to QoL.” More specifically, OPDP argued that because the clinical trial only included PROs for health-related QoL as secondary endpoints and not alpha allocation, it is unknown as to whether or not the QoL outcome data “represents a false positive finding that occurred by chance alone.” Moreover, OPDP noted that the claim that the drug product “helps preserve quality of life so . . . [patients] are living well” inappropriately implies that patients are “living well” before they begin using the drug for treatment. Thus, OPDP found the PRO data to be exploratory, as it was not designed to capture the concept of “living well” and failed to demonstrate or support that the drug product “helps preserve quality of life” or actually supports patients “living well.”
Similarly, OPDP found that the SUPER, which presented the 26-month check-in data from the clinical study, “created a misleading impression regarding the benefits of [the drug product] because of the significant limitations to the PRO analysis performed” in the trial. More specifically, OPDP found that (1) the company did not demonstrate that the PRO assessments were completed frequently enough to appropriately collect supporting data at the 26-month check-in; (2) did not account for concerns that QoL had the ability to significantly fluctuate and vary between assessments; (3) did not include assessments that “demonstrated the appropriateness of the intervals used to asses global QoL in the trial”; and (4) limited responses to patients’ perceptions of their QoL by only incorporating a measurement tool assessed by a 7-day recall period. Additionally, because the clinical trial was not designed to account for potential non-treatment and non-disease-related factors (confounding factors), the claims in the SUPER were inappropriately based on outcomes that may have reflected elements of a patient’s QoL that were not directly related to the disease and treatment being studied.
Presentation of Benefit Claims
OPDP found the presentation of the claims and data in the TV ad concerning, particularly taking issue with its comprehensibility. OPDP argued that although the ad contained the SUPER “[t]his analysis was not pre-planned to detect a false positive,” the text was “not sufficient to mitigate the overall misleading impression created by the presentation of the PRO claims and data.” OPDP discussed how the TV ad’s chaotic nature distracts the viewer from material information about the benefits of the drug product, therefore creating a misleading impression about the drug’s efficacy. For example, OPDP highlighted that the number of words in the TV ad’s SUPER was “more than twice the number of words, on average, than an adult can read within 5 seconds…[and] during the 5‑second period that the SUPER appears, there are multiple competing audio and visual presentations.” OPDP also highlighted that the material information of the SUPER was outshined by competing claims that were in larger text and more centralized on the screen, undermining the SUPER’s effect on the viewer.
OPDP concluded that by “presenting compelling and attention-grabbing visuals. . .during the presentation of the SUPER, which itself is presented in a manner that would not allow most viewers to read, process, and comprehend the material information it presents,” the ad was misleading and undermined the communication of important information relating to the drug’s efficacy.
Practical Takeaways
- OPDP continues to pay close attention to DTC ads as they are targeted to patients. When creating DTC ads in 2024, marketers should be mindful of the DCT Final rule that will go into effect on May 20, 2024, with a compliance date of November 20, 2024. The DTC Final Rule modifies how a company must present “the major statement” (i.e., the presentation of major risk information) in DTC TV and radio advertising.
- QoL claims continue to be difficult to make in promotion. Before making QoLs claims, companies should ensure that all studies are designed appropriately to support said claims. In this case, for example, OPDP raised several concerns about the limitations of the PRO data, noting that “[t]he exploratory… analyses in MONALEESA-2 were not designed to capture the concept of ‘living well’.”
- OPDP expects companies to present risk information clearly and prominently and in a manner that consumers can easily understand. Companies should keep in mind that how a claim is presented is just as important as what is being said, and that any visuals or other attention-grabbing tactics should not undermine the presentation of material information about the drug’s efficacy.
For more information on the advertising and promotion of drugs, biologics or medical devices, please contact:
- Carolina Wirth at (202) 780-2989 or cwirth@hallrender.com;
- Jemalyn Harvey at (202) 780-2990 or jharvey@hallrender.com; or
- Your primary Hall Render contact.
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.
