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DTC-In-Perspective by Bob Ehrlich

The Implications of the Ubrelvy Letter from OPDP

October 22, 2024 0

On 8/29/24, AbbVie received a notice from FDA’s OPDP that their Serena Williams DTC television ad violated the FD&C Act. The reasons cited are for overstating the benefits of Ubrelvy. The untitled letter illustrates the difficulties pharmaceutical companies face in presenting benefit information that satisfies FDA requirements.

Ubrelvy tried to meet FDA requirements and do it in a :30 second ad. For drug ads, this is very hard to do given most drug ads need :60 and :90 seconds because of complex benefit claims and fair balance. AbbVie has used Serena Williams as a migraine relief spokesperson for several years. She has been an excellent example of a celebrity endorser. Serena has the migraine condition and the ads are presented in a unique creative style.

What happened in this case that OPDP called the ad violative? In sum, OPDP said the stated benefit of providing one dose rapid relief was not consistent with clinical data. That data showed only a minority of users got relief that quickly. The television ad claimed in a large super, “Ubrelvy Quickly Eliminates Migraine Pain”. Serena’s audio says, “One dose works fast to eliminate migraine pain.”

OPDP also had concerns that Serena, as a celebrity, further added to the potential for consumers to believe the one dose rapid relief claim was true for all users of Ubrelvy. OPDP cites several studies supporting the idea celebrities add to claim believability.

OPDP acknowledges that the ad had a small qualifying super saying “some people had pain freedom within 2 hours.” That small super was insufficient in balancing the ad’s stated claims of rapid relief. OPDP says the speed of relief and one dose claims are misleading because they do not work for everyone.

The Ubrelvy case is important because it illustrates the difficulty drug makers have distilling complicated clinical results into concise advertising claims. Ubrelvy and almost all other prescription drugs provide benefits for some but not all users. Trying to get to that one compelling benefit in DTC ads is difficult given that clinical data is mixed in patient outcomes. Drug claims need to have significant enough disclaimers on efficacy to clearly communicate the extent of the benefit.

In this case, OPDP felt Ubrelvy did not present the proven clinical benefits clearly enough. I should point out the Serena ad in question is not vastly different from the other Ubrelvy ads run from 2022. The earliest ads from 2020-2021 were less declarative, however, in the claim using the word “can” help relieve migraines.

I am not sure if OPDP questioned prior ads or had discussions with Ubrelvy during the pre-clearance process. There is a redacted paragraph in the letter that indicated previous OPDP concerns about Ubrelvy ads. This was when Allergan owned the brand before being acquired by AbbVie. Most drug ads are pre-cleared at least for the first campaign used. Sometimes new versions are not pre-cleared if similar enough to earlier ads.

AbbVie has been asked to stop running the ad and it will be interesting to see their response to OPDP. Usually if the pharmaceutical company stops running the ad, the FDA will not take further action requiring corrective advertising.

 

 

 

Bob Ehrlich

DTC NewsGuest Columnist

Patient Influencers are the Night Vision Goggles for DTC Marketers

January 20, 2015

No matter the preparation, resources or rigor applied, there is often an element of marketing that is done in the dark. Even in today’s data-rich, hyper-connected world there is a degree of guesswork resident in the process. Don’t get me wrong, the marketers making these educated guesses are bright people who get it right a lot of the time. But just not all of the time. Absolute confidence in marketing is an elusive beast.

So with that as the backdrop, imagine there is a way to edge ever closer towards absolute confidence, to raise the odds of getting it right, and ultimately elevate the game to a whole other level where there is almost no darkness at all. And what if I told you there are special goggles that could give the DTC marketer “night vision,” the ability to see in the dark?

While unfortunately not available in goggle form, the full promise of the above is nonetheless realizable today. It all begins with patient influencers, the empowered patients who drive the healthcare conversation online. They are bloggers, tweeters, pinners, and leaders of Facebook pages. They are the leaders in their communities, from virtually every health condition.

A study published several years ago by Forrester’s Josh Bernoff and Augie Ray, Online Peer Influence Pyramid, indicated that the top 4% at the apex of the social pyramid are responsible for creating about 80% of all content online. Think about that – it’s an incredible statistic. Those at the top of the pyramid – the “social broadcasters” and “mass influencers,” using Bernoff’s and Ray’s labels – are the influencers.

In the DTC realm, patient influencers are the catalysts of the patient empowerment movement.  WEGO Health, the company where I work, has a network of these 100,000 patient influencers. Each reaches approximately 15,000 health consumers every month. These patient influencers not only speak to their respective communities but are also in the unique position to be able to speak for them. They understand the macro and micro needs of these communities like no one else. They represent an invaluable body of knowledge. Patient influencers want to be heard, and DTC marketers need to hear them.

So what does this all have to do with night vision goggles and where is the real disruptive innovation, you may ask? The answer lies in patient influencer advisory panels.

By assembling a group of 30 or so patient influencers within a given condition area and then strategically accessing their wealth of knowledge on a regular and recurring basis throughout the course of the year –WEGO Health has found a solution that gives marketers ongoing, on-demand access to the patient voice. Patient influencer advisory panels can imbue the marketer with more certainty in knowing what consumers really want and need, to possess a keen understanding of the barriers in their way, and be able to gauge their perspective on solution concepts in their earliest stages of life – all before marketing to them.

An optimized combination of virtual online focus groups and short-form studies are the key to effective advisory panels, giving marketers ongoing, on-demand access to the patient voice. WEGO Health’s virtual focus groups are known as Community Insight Groups and its short-form studies are conducted via its smartphone platform, called Truvio, which enables marketers to quickly capture actionable insights in the form of keypad and often-poignant audio responses. Many companies even alter their marketing strategies based on this valuable patient input.

Seeking the perspectives from these patient influencers throughout the year enables marketers to unearth knowledge gaps, shape strategic and tactical planning, refine programs, and much more. But what it really does is minimize the guesswork in marketing. And it achieves that by enabling markets to see in the dark.

Todd Kolm will delve further into this topic during WEGO Health’s panel discussion with pharma marketers and patient influencers at the 2015 DTC National Conference. This session will address the patient-centricity gap and how DTC can help, in part by reacting to findings from the original study, Online Communities and Patient-Centricity 2015. This February 2015 study, with results presented for the first time ever, will feature both data and recorded verbal responses from respected Patient Community Leaders across multiple therapeutic areas. Don’t miss out – only at the 2015 DTC National Conference, held April 7-9 at the JW Marriott in Washington, DC. Register today!

Todd Kolm