|Footnotes for this article are available at the end of this page.
Better Than Ezra’s early 1990s single, “This Time of Year,” came to mind when we saw the Food and Drug Administration’s Office of Prescription Drug Promotion issue its first Untitled Letter (also known as a Notice of Violation (“NOV”)) to a drug company for a television advertisement that overstated product efficacy.1 OPDP has not issued a Warning Letter this year.
One reason for the Better Than Ezra reference is that the TV ad suggested it was “better” than others, including many quality of life (“QoL”) claims. A second reason is the inevitable question — will this time of year be different? Do we expect more NOVs and Warning Letters this year compared to the four NOVs and one Warning Letter issued by OPDP last year?
- The drug company promoted its prescription cancer product in a TV ad.
- The ad referred several times to preserving QoL and living well.
- OPDP identified a number of limitations to the Patient Reported Outcome (“PRO”) analysis in the company’s supporting data:
Specifically, while PROs for health-related QoL were included in the trial as secondary endpoints, there was no alpha-allocation. Since there was no alpha-allocation, and, therefore, no specified false positive error rate, it is not known whether the QoL outcome data represents a false positive finding that occurred by chance alone. The PRO data in the cited references are, therefore, considered exploratory (i.e., hypothesis generating), and they do not, as you have claimed, demonstrate that [product] “helps preserve quality of life” or that it supports patients “living well.”
- OPDP noted that it “encourages thoughtful inclusion of patient-reported outcomes in the design and conduct of clinical trials,” where appropriate, citing three FDA guidances.
- OPDP acknowledged superimposed text (“SUPER”) in the ad stating that the “analysis was not pre-planned to detect a false positive,” as well as the presence of other claim qualifiers. However, FDA said that the qualifiers were insufficient to mitigate the overall misleading impression created by the prominent PRO claims and data.
- There were also “multiple competing presentational aspects” that could distract the viewer.
- OPDP objected to how long the ad displayed the SUPER (48 words in approximately five seconds); an average consumer would not be able to read, process, and comprehend the message (and, again, competing positive audio and visual presentations and claims were present during this timeframe).
- QoL claims are tricky. While promoting QoL benefits is not unlawful per se, it must be truthful and not misleading. In this case, OPDP raised concerns about the limitations of the PRO measure.
- A company must present risk information in a prominent, conspicuous, and user-friendly manner so that the viewer can read and comprehend the message. A consumer should not have to be a speed reader or overcome large promotional audio and visual graphics to understand claim limitations.
- A DTC ad (here, a TV ad) will often raise more scrutiny from OPDP because of the patient/consumer audience.
- Is this NOV a portend of things to come? We thought Warren Zeven and The Smiths would have been in the Rock and Roll Hall of Fame by now, so we are hesitant to predict. However, the NOV reminds industry that OPDP continues to focus on the presentation of risk information and will look more closely at QoL claims.
Just as Better Than Ezra sang, “Well, I know there’s a reason to change this time of year,” companies should also take this time of year to review product messaging.
 See https://www.fda.gov/media/175584/download?attachment.