It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming!

With apologies to Rob Base and DJ EZ Rock, it took more than “two” to get this Emgality DTC TV commercial right (insert snare drum here please).  Reading the Untitled and Closeout Letters to Eli Lilly regarding DTC TV promotion for Emgality, as well as Lilly’s recently posted response to FDA, this blogger couldn’t help but be reminded of the principles articulated in FDA’s long-withdrawn Draft Guidance on “Help Seeking” and Disease Awareness Communications – particularly the discussions about when disease awareness promotion is coupled with a product reminder or full product ad.  The Letters, and the withdrawn Draft Guidance for that matter, raise the not-so existential question about when disease awareness materials become product promotion.  Despite the Draft Guidance being withdrawn for over 6 years, the concepts articulated in it often come into play when reviewing disease awareness materials.  Speaking from a bit of experience, this has led to countless field direction memos instructing sales reps on how to pivot from their opening disease awareness presentations to their product details in an effort to keep these two types of communications separate.

But the Emgality promotion at issue here is different than the typical disease awareness communications where companies employ the “pivot” technique.  Here, Lilly created a “complete TV broadcast” that was made up of three distinct components to be aired sequentially.  Component 1 was a disease state component – identified as “The Journey Forward: Ryan Murphy” or “The Journey Forward:  Allysa Seely.”  (Note that Allysa Seely is a Paralympian gold medal triathlete, and swimmer Ryan Murphy is a 2016 Olympian and gold medalist.)  These two videos, which both began with a voiceover that stated, “Lilly presents The Journey Forward,” could be used alternatively as Component 1 and discussed the burden of migraine and its symptoms with the following content:

• “I do a whole bunch of different things to try to prevent migraine because for me the pain is really tough” (Ryan Murphy TV Ad)
• “I’ve leaned on all kinds of doctors and professionals for help” (Ryan Murphy TV Ad)
• “When I was younger, I used to say that my brain hurt” (Allysa Seely TV Ad)
• “By the time I was in college, migraine had me hiding from light and sound, it was isolating” (Allysa Seely TV Ad)

In its Untitled Letter, FDA cited the “The Journey Forward” ads as including “brought to you by Emgality proud partner of Team USA.”  FDA alleged that because the TV ads contained representations or suggestions relating to Emgality’s indication for use, they were required to include risk information as well adequate provision for the dissemination of the PI or a brief summary as required by 21 C.F.R. § 202.1(e)(1).  In addition, because the ads referenced migraine, the ads should have included “material information regarding Emgality’s full FDA-approved indication,” notably, that Emgality is indicated for the preventive treatment of migraine in adults.  FDA did not otherwise challenge the content of the disease awareness portion of the ad.

Lilly clarified in its Response that “brought to you by Emgality” was Component 2 of what Lilly described as the three component “complete TV broadcast.”  Component 1 was one of the disease awareness videos cited by FDA, Component 2 was “brought to you by Emgality,” and lastly, Component 3 was a full Emgality DTC TV commercial that included risk information as well as adequate provision for the dissemination of the PI.  Because all three components were to be aired sequentially, with Component 3 including risk information and adequate provision, the complete broadcast was balanced and included Emgality’s full FDA-approved indication – thus addressing the issues cited by FDA in the Untitled Letter.  Lilly also confirmed that each airing of the TV broadcast content included all three components.

In defending the complete broadcast, Lilly called out similar elements from each of the individual components as demonstrating its intent to have all three viewed sequentially.  Interestingly, this same point was made by FDA in viewing Components 1 and 2 as its own cohesive ad with “a clear beginning, middle, and end to the presentation.”  FDA’s Closeout Letter is particularly helpful in describing some of the perceptual similarities between Components 1 and 2, which included background music that plays continuously through the presentation, the same voiceover artist introducing Component 1 and voicing “brought to you by Emgality” (Component 2), and the same “style” and “color” for the opening and closing presentations.

It’s understandable that Lilly would create an ad with three separate components that had flexible uses.  Creating TV commercials ain’t cheap nor is the air time for them.  Being able to leverage different commercial lengths and platforms helps ensure the most bang for your buck.  And in this case the presentation would be compliant whether each component was shown individually, or, when combining all three sequentially.  But if the three segments were intended to be combined sequentially for a complete TV broadcast, why wasn’t the complete TV broadcast submitted to FDA on Form FDA 2253?

In its Response, Lilly stated that, “Component 1 did not contain a reference to Emgality and thus the file was not submitted to OPDP on Form FDA 2253.”  While this may be true, an overt reference to the drug may not be the only thing that renders a communication product promotion.

Whether disease awareness and help seeking materials can be considered product promotion is a hotly contested area.  FDA enforcement letters and FDA’s withdrawn Draft Guidance shed light on the Agency’s thinking.  In its Draft Guidance, FDA made clear that:

the mere appearance of the company’s name in conjunction with a disease reference could trigger the act’s advertising or labeling requirements, depending on the overall meaning and context of the communication. Similarly, depending on meaning and context, FDA might have jurisdiction over statements regarding the benefits of a product class to which a company’s drug or device belonged, even if the communication in which the statements occurred did not mention any specific product. Where FDA does not have jurisdiction, the agency may nevertheless take appropriate action (e.g., issuing a public statement or referring the matter to the FTC) where we believe a communication is false or misleading, or includes an unbalanced presentation of the benefits and risks of a particular product class.

This content is likely one of the reasons for FDA’s withdrawal of the Draft Guidance in 2015 – the same year that FDA suffered one of the most significant blows regarding First Amendment protections for pharmaceutical manufacturer speech.  The sweeping statement that the mere name of a company and a disease state could trigger the Act’s advertising or labeling requirements may have had a chilling effect on the way companies chose/choose to engage in disease state education.  In Lilly’s case, while this blogger does not believe that Component 1 should automatically be deemed Emgality promotion merely because it included Lilly’s name and discussed migraine, the context and circumstances of its presentation, including its use with more traditional Emgality promotion, should be taken into consideration.  There would have been little downside to submitting to FDA Component 1 as Emgality promotion, particularly because it was intended to be used with Emgality-branded communications and was otherwise consistent with what could be said in promotion.

This situation is also vastly different from “help seeking” communications that center mostly around treatment without mentioning the treatment name.  For example, a year after the Draft Guidance’s publication, FDA issued an  Untitled Letter to Pfizer for, among other things, a 27-minute infomercial on arthritis and joint pain relief.  FDA took the position that:

The infomercial points to and describes benefits from taking a specific prescription drug therapy from Pfizer, though it does not mention Celebrex or Bextra by name. The infomercial features patient testimonials and statements from healthcare providers that promise complete pain-free relief, freedom of movement, and dramatic effects on “quality of life” in terms of personal activities and work-related activities for arthritis patients, linking these benefits to a specific drug therapy, and solicits patients to seek out that specific medicine. Pfizer’s name is featured at the beginning, end, and throughout the infomercial.

In this case, the 27-minute infomercial, which never mentioned the name of a drug, otherwise described “a powerful prescription medicine that’s giving people back their lives” without making reference to the drug’s risks or providing a brief summary/adequate provision for PI dissemination.  And remarkably, Pfizer submitted the infomercial to FDA on Form FDA 2253 but seemingly took the position that because no product name was mentioned, it did not need to meet traditional advertising and labeling requirements.

So back to Lilly – if Lilly were to have submitted Component 1 as Emgality promotion on Form FDA 2253, would that have eliminated or minimized Lilly’s ability to use it as a standalone piece that does not otherwise include fair balance and adequate provision for PI dissemination?  To the extent that Component 1 was not otherwise referencing Emgality treatment, and was simply about migraine, this blogger argues Lilly should not be so limited.  FDA would be significantly overreaching by claiming that Lilly could not utilize Component 1 as appropriate disease awareness material simply because the communication included Lilly’s name and may have been utilized in other contexts as product promotion.

One of the questions this blogger often receives is how different disease awareness materials need to be from branded product promotion.  Often companies get hung up on perceptual similarities with product promotion, without focusing on the substance of their communications.  For this blogger, disease awareness presentations do not always need to look different from product promotional materials – the key is the context of the communication and whether the disease awareness material includes information that would otherwise not comply with traditional product promotion.  Companies that seek to engage in disease awareness promotion often do so to raise awareness about the burden of disease and its impacts on quality of life.  To effectively educate on disease, communications may address subjects that go beyond what can be discussed in traditional product promotion – whether it is a symptom that may lead to a disease diagnosis but for which the drug has not shown efficacy in treating, or in discussing further reaching impacts the disease may have on quality of life that could be construed as unsubstantiated implied claims for a treatment.  These are the “pivot” situations, where it is helpful to clearly distinguish disease education from product promotion.   That said, companies should not shy away from owning other disease state materials as product promotion under appropriate circumstances, and that ownership shouldn’t limit the company’s ability to appropriately leverage those communications in capacities other than traditional product promotion.