But Is It Insta-Worthy? OPDP’s First Letter of 2022

February 7, 2022By Dara Katcher Levy & Sara W. Koblitz

Well, OPDP is kicking off 2022 in a big way – taking on an Eli Lilly Instagram post with video for Trulicity.  This is the second time in a little over a month that Eli Lilly has found itself caught in OPDP’s cross-hairs.  On the heels of a December 2021 Untitled Letter about Lilly’s multi-part infomercial supporting migraine-treatment Emgality, OPDP sent Lilly its first Untitled Letter of the new year on January 19, 2022 over the company’s Instagram posts for Trulicity, a biologic licensed “as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus” and “to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.”  Given that FDA issued only four Untitled Letters total in 2021, it’s notable that FDA has issued two to Eli Lilly in the span of five weeks.

What makes this letter a significant way to start off 2022 is the promotional platform at issue—Instagram, and the promotional material type—a post with a video presentation.  The Instagram square has previously been a focus of OPDP’s, but this is the first time (to our knowledge) OPDP has taken issue with an Instagram post including a video component.  And while we haven’t seen the video that is the subject of the letter (only screenshots), we are, quite frankly, surprised it took OPDP this long to object to this type of promotion.

In the case of the Lilly Instagram posts, FDA expressed concern that the Instagram posts create a misleading impression with respect to the safety and effectiveness of a drug subject to a Boxed Warning rendering the drug misbranded.  The post contained a video entitled 10,080 Minutes that “prominently communicates that Trulicity can help ‘lower A1C along with diet and exercise,’” but “fails to adequately communicate Trulicity’s FDA-approved indication and the limitations of use” thereby creating a “misleading impression about the scope of the FDA-approved indication.”  Further, though any relevant discussion is redacted, the Untitled Letter suggests that FDA had previously provided comments to Lilly about its Trulicity promotion more generally.

That the 10,080 Minutes video did not prominently limit its “lower A1C” claims to adults with type 2 diabetes mellitus and did not adequately include any Limitations of Use raised OPDP concerns given the “serious risks of this product.”  Indeed, OPDP recognized that the ad did include the indication and limitations of use but explained that the presentation was not sufficient:

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 (fastpaced 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.

FDA further emphasized that an assessment of promotional communications not only include representations made or suggested but “the extent to which the promotional communication fails to reveal facts material in light of the representations made or with respect to consequences that may result from use of the drug as recommended or suggested in promotional communication.”  And though those material facts may be present, sometimes that just isn’t enough:

The post prominently presents benefit claims and representations about Trulicity 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 window relegated to the bottom of the post and is presented using fast-paced, scrolling, small font that is difficult to read and cannot be adequately processed or comprehended by consumers.

It’s therefore the lack of fair balance and the omission of warning and precaution information that “creates a misleading impression about the drug’s safety” while the “overall effect . . . undermines the communication of the important risk information” and “misleadingly minimizes the risks associated with the use of Trulicity”—even if the necessary information is there.  (While we recognize that OPDP also cited the absence of “material information from the warning and precaution for hypoglycemia with concomitant use of insulin secretagogues or insulin” this was the last issue cited and likely not the basis for issuing the Untitled Letter.)

These issues are not new—although the fact that this is an Instagram post with video raises a new context for considering them.  Back in 2016 and 2019 we reported on FDA’s objections to TV commercials that included fast-paced “compelling and attention grabbing visuals” (note the similar language) as they were competing for the consumer’s attention while the major statement conveyed risk information.  Here, the visuals in the video, including large font text for benefits, overshadowed the smaller, scrolling text that conveyed risk.  That FDA took action is not surprising – particularly given the product has a Boxed Warning and OPDP has previously identified promotional material for drugs with serious risks as one of its enforcement priorities.  Not to mention the posts had been submitted through OPDP’s Bad Ad program.

So what’s the takeaway here?  CONTEXT (citing the great Roger Thies, IYKYK) —it’s a core tenet of promotional review.  When reviewing a promotional piece, the reviewer is not just looking at the piece itself, but also needing to understand the audience, the platform, how will it appear or be used, etc.  It’s not enough to review screenshots of a banner ad—one needs to know how long each presentation remains on the screen before moving to the next and whether text is legible and can be read and understood given changing visuals.  Platforms are also important—for instance, would a compliant audio/visual DTC TV commercial be compliant if it was shown on an LCD screen with no sound in a doctor’s waiting room?

Companies need to be aware of who is consuming their social media content and how it is being consumed.  Scrolling, small-font text at the bottom of an ad will rarely be able to compete with benefit information presented “above the line.”  And ultimately, decisions need to be made about whether the promotion is really Insta-worthy.