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Does anyone remember the 1980’s song, “Freeze-Frame” by The J. Geils Band? A new year, a new Untitled Letter issued by the Food and Drug Administration’s Office of Prescription Drug Promotion to a prescription drug company.1 No, OPDP did not send New Year greetings when it found the company’s Instagram ad to be false and misleading about claims made about the product’s benefits and risks.
The Untitled Letter, the first for 2022, included a number of issues and concerns raised by OPDP in the past (which we have pointed out in other Bulletins). We will summarize the main points raised by FDA in this most current letter and offer our own recommendations to maximize compliance.
- The company submitted a social post – an Instagram ad, on a Form FDA 2253, so OPDP saw the ad.
- OPDP also learned of the post through the Bad Ad Program. The Bad Ad Program is an initiative by which healthcare professionals can contact the agency and share concerns about what they believe to be suspect prescription drug product promotion.
- The labeling for the product included a Boxed Warning about a risk associated with the incidence of thyroid C-cell tumors associated with the use of the product (in addition to other noted contraindications and warnings).
- Prior to issuing the Untitled Letter, OPDP provided advisory comments to the company on four separate occasions.
- The agency notified the company that it was promoting the drug “without presenting the benefits and serious risks of the drug in a truthful and non-misleading manner, despite concerns previously expressed by OPDP.”
- The agency determined the Instagram post was misleading, in part, because the video did not include the full FDA-approved Indication and Limitations of Use, which provided a misleading impression about the scope of the FDA-approved indication for the product while also displaying certain required information too fast and in a distracting, non-prominent manner. As described in the letter:
OPDP notes that the indication and the limitations of use are presented only in small, fast-paced scrolling font in a small window below the video, relegated to the bottom of the post, competing for the consumer’s attention with several distracting video elements (fast-paced visuals, frequent scene changes, busy scenes, large-moving superimposed text, and a strong fast-moving musical beat) that detract from the communication of the indication and limitations of use. Therefore, this presentation does not mitigate the misleading impression created by the post.
- OPDP expressed concern about the presentation of risk information:
[t]he post prominently presents benefit claims and representations about [the product] emphasized by colorful, compelling, and attention-grabbing fast-paced visuals that take up the majority of the post in a video with frequent scene changes, busy scenes, and large-moving superimposed text along with other competing modalities such as the strong, fast-moving musical beat. In contrast, the risk information is in a small font that is difficult to read and cannot be adequately processed or comprehended by consumers.
- The Untitled Letter noted that the company did not provide sufficient information from a specific warning and precaution, so “the post creates a misleading impression about the drug’s safety.”
- As noted, the Untitled Letter included many concerns that OPDP has previously cited in other letters (and about which we have counseled and written). The letter was the result of a nearly perfect storm of problems.
- Social media posts, such as Instagram ads, remain a high area of scrutiny because it can be difficult in such ads to meet FDA fair balance requirements due to limitations on the number of characters permitted on the platform.
- Products requiring Boxed Warning, because they have been determined to present a specific, high safety risk, remain a priority for agency review and, as warranted, enforcement actions.
- A Bad Ad Program complaint likely prompted, in part, the issuance of the Untitled Letter, so not only OPDP is watching.
- The inadequate presentation of a product’s Limitations of Use is a recurring theme in recent letters.
- Not following OPDP’s Advisory comments comes at a risk; while these comments are not legally binding and a company is not required to accept them, they should be seriously considered.
- It is interesting that OPDP used “truthful and non-misleading” language, which is verbiage used by a few courts that have challenged past FDA enforcement letters.
- To quote Freeze-Frame: “There were no defects to be found;” here, there were plenty of defects to be found, and companies should take the opportunity to learn from others’ mistakes.
- Companies, through their Promotional Review Committees (or similar groups), should review the recent letter and consider the issues cited to see how to minimize the issuance of an OPDP letter concerning their own promotional materials.
 www.fda.gov/media/155627/download. Interestingly, OPDP issued another letter to the same company (for a different product) in December. See our Bulletin at https://www.agg.com/news-insights/publications/you-cannot-do-it-any-way-you-want-it-fda-issues-an-untitled-letter-for-an-incomplete-journey-forward/.