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title: Klick Wire
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Klick analysis of the 49 FDA letters

                                                           

|    Sign Up Today   View in Browser  Issue 683 September 22   90% Letters on TV 72% Like DTP 49% Trust Pharma 66% Say AI for Drugs YouTube To Pass TV? GEO vs. SEO     |
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|     Regulatory 49 letters, 146 issues, 1 big week for pharma marketers Source: Klick Health This story links to Klick's POV on the 49 letters issued to pharma brands last week. The letters were sent to the brands on Sept 9 but were posted on the OPDP Untitled and FDA Warning Letter sites. 116 Letters, 49 For Promotional Materials   We only look at the 49 letters for the promotional materials. When looking at the charts you can essentially determine the number of letters by halving the percentage.  By far, the most common channel cited was TV ads, with some of the others, such as interviews, also on cable TV. Chart created from data in Klick source \| \* YouTube videos also aired on TV   Problems Cited Mostly Follow FDA Norms   While the volume of letters was unprecedented the problems cited will remind many marketers of their most recent MRL / PRC review meeting.  Chart created from data in Klick source   If we group claims vs. risks vs. process violations we get 56.2%, 38.3%, and 5.5%, respectively.  Where To Now?   These letters fulfil only half of the statement in the White House Memo. The half that said the FDA was to look closely at TV ads. Missing, however, is the half that wanted the agency to look at influencers. There were no letters featuring paid influencers or any social media at all. It would be Pollyannaish of us to think that these aren't coming. We will give the final word to the POV authors: The recent FDA enforcement actions are not new and remain highly relevant, providing valuable intel that complements prior guidance. This moment presents an opportunity to reinforce already well-established practices and refine processes where risk is highest. Thorough reviews not only protect patients but also safeguard brands by aligning communications with both regulatory expectations and internal standards.   — Read the full story from Klick Health         Direct to Patient 72% running or considering a direct-to-patient program Source: DHC Group The DHC is hosting a webinar on Thursday (Sept. 27th at 1PM) all about pharma marketers' plans for 2026. The speakers are all coming with data and opinions on market plans, and the DHC has data from a new study.  Pharma marketers were asked about plans for direct-to-patient programs. Nearly three-quarters are already running programs or planning them. Image adapted for email from DHC Group source   Register and hear from the speakers: Chuck Sachs - Director, US Commercial Innovation, AstraZeneca Matt Walsh - General Manager, BioPharma, ixlayer Andrew Smith - VP of Consulting, Klick   — Read the full story from DHC Group         Data Management Pharma is #3 on the trusted list, still below 50% Source: Usercentrics Usercentrics conducted a study of 10,000 people across seven countries (six in Europe and the US) about trust and data usage. Unsurprisingly, trust is low and many users say they are accepting fewer cookie agreements on websites than they used to. Image adapted for email from Usercentrics source   The US is the lowest in this list, 38% say they accept fewer agreements, but that is still as solid third of the audience.  Some good news, though, is that medical and pharma ranks relatively high on the "trustworthy" scale. Image adapted for email from Usercentrics source   It's a Pyrrhic victory however, notice that only one industry got over 50%. — Read the full story from Usercentrics         Are You Learning Everything You Can from an FDA “No”?             Klick’s latest POV, From No to Know: Translating Regulatory Setbacks into Competitive Advantages, analyzes 200+ Complete Response Letters to reveal why submissions fail and how teams can avoid the same pitfalls. Discover how regulatory insight, early alignment, and adaptive planning can help you build stronger, faster, and more confident submissions. Turn setbacks into strategic advantage.   Read our perspective now       AI in Health 66% say AI should help make new medicines Source: Pew Research Pew Research surveyed 5,023 American adults about AI usage in 2025. One of the questions was what role AI should play in different tasks. Here, we see development of medicines is high on the list. Image adapted for email from Pew Research source   Almost half of respondents think that AI can help with direct mental healthcare as well. Corporate marketers can probably feel secure talking about AI in R&D.  However, brand marketers need to be careful about AI use in content. 76% of Americans say it is "extremely important" that brands disclose when they use AI for content. Image adapted for email from Pew Research source   — Read the full story from Pew Research         Connected TV YouTube only a few years away from #1 spot Source: Nielsen Looking at the linear video landscape we see that streaming is the biggest chunk at almost half. Image adapted for email from Nielsen source   We also see over the past year YouTube has gained 2.5% and that's a lot in this relatively stable market. If that growth continues and the degradation in Broadcast and Cable also continues we could see the platform surpass those channels in 2026. Image adapted for email from Nielsen source   Extrapolation of change with Broadcast and Cable estimated to reduce losses (actuals -2.9% and -3.8%, respectively). Estimates based on modified past year losses for Broadcast and Cable   — Read the full story from Nielsen           GenAI Search Change is not impact, GEO not yet SEO Source: BrightEdge A new report from BrightEdge serves to remind us that "growth" is not "impact." The first chart featured in the company's latest GenAI Search report is growth or change of GenAI search referrals (notoriously low, as we know). Image adapted for email from BrightEdge source   This chart makes us suspicious that the company is "chasing error" as the numbers bounce all over the place with Grok losing 33% one month and then gaining 1,279% the next. The "chasing error" issue seems to be exacerbated by extremely low absolute numbers as the next chart shows. Image adapted for email from BrightEdge source   What these charts don't show us is the absolute reduction in traffic. Pew Research highlighted that back in July. — Read the full story from BrightEdge         Glass Box Transparency for Confident MLR Reviews             Compliance decisions shouldn’t be a “black box” mystery. Guardrail™ uses “glass box” transparency to clearly explain every compliance flag with evidence-backed insights. No hidden logic, just clear decisions that accelerate approvals and boost your team’s confidence.   See Guardrail in Action       Market Research Gen Z as likely to use AI as Google to research Source: Future Commerce We haven't had a good, solid "where are they now" look at consumers for a while. This study by Future Commerce looks at how consumers in the US, UK, and Australia / NZ are researching products in 2025. Facebook Still (!) Top Platform   No matter now much the pundits predict the downfall of Facebook, it still remains at the top of the "what are you using" charts. When asked which platforms they had used in the past month, Facebook, YouTube, and Amazon round out the top three with Search at number four. We wonder, though, if "Google" the brand might have done better. Chart created from data in Future Commerce source   This chart was sorted by the averages of the platforms. The prevalence of WhatsApp in the UK is intriguing.  Smartphones Are The Ubiquitous Devices   This chart shows how many respondents use a give device (across all three markets) and then how many use that device to purchase physical goods (not subscriptions). Interestingly, the smartphone has buried the venerable computer in the top spot for both. Chart created from data in Future Commerce source   AI For Research Growing   Gen Z may not "like" AI as much as Millennials, but they are certainly using it. This question was a single choice between six items with the top two answers being: Image adapted for email from Future Commerce source   However, two of the other answers were Amazon's AI Rufus and retailers' AI chatbots. If we add all three AI answers together we get this: Chart created from data in Future Commerce source   This isn't really fair because the greater answer "real estate" will artificially increase results, but it serves to show how popular AI research has become in only a few short years. — Read the full story from Future Commerce         GenAI Search 87% read AI search summaries... and then... Source: Search Engine Land A study of 4.604 US citizens conducted in July found that 87% of them read AI summaries on search results. Once they have read they summary they take different actions: Chart created from data in Search Engine Land source   With only 8% of searches resulting in a click we know that the 41% who say they click don't do it every time.  84% of respondents say they use AI for shopping. These users tend to use AI for research in multiple ways: Image adapted for email from Search Engine Land source   — Read the full story from Search Engine Land         Social Media If not Facebook-first, at least Meta-first Source: eMarketer Evidence continues to roll in that social media is still somehow Facebook-first, especially for pharma. Meta has certainly built products that people want to use and have people advertisers want to reach. Looking at US revenue figures, Meta is almost three-quarters between Facebook, Instagram, and its other platforms. Image adapted for email from eMarketer source   This story talks about Meta's regulatory headwinds but for now at least it is top dog in the US social space. — Read the full story from eMarketer         mHealth Apple Watch gets FDA approval for hypertension Source: Apple Apple Watch version 9 or higher will be getting hypertension detection in the next OS update (with iPhone 11 or higher) . Unless your country isn't on the list (looking at you, Canada). Apple used AI to sort through the data from 100,000 people enrolled in a heart and movement study it originally launched in 2019 to see whether it could find features in the signal data from the watch's main heart-related sensor that it could then match up with traditional blood pressure measurements, \[Sumbul Ahmad Desai, Apple's vice president of health\] said. —Reuters   — Read the full story from Apple         TikTok TikTok "framework deal" keeps the platform on Source: The Drum A "framework deal" is in place and the deadline for a final deal has been pushed out to December 16th.  At the core of the arrangement is a US consortium led by Oracle, Silver Lake and Andreessen Horowitz, which would control roughly 80% of TikTok’s US operations. ByteDance, TikTok’s Chinese parent, would retain a minority stake and continue to license the recommendation algorithm to the American entity. US user data would be housed in domestic data centers under Oracle’s oversight.   — Read the full story from The Drum         Generative AI 18% use ChatGPT for search, 5.7% for health Source: Visual Capitalist A new chart from Visual Capitalist looks at how people use ChatGPT based on OpenAI data up to July 2025. The raw tasks includes health & fitness at #6 (but also includes beauty so not strictly health). Chart created from data in Visual Capitalist source   Searching for specific information is far ahead in first place at 18.3%. If we consolidate the OpenAI categories, however, search goes to third place after "how to" guidance and writing (though "how to" could also be search). Chart created from data in Visual Capitalist source   — Read the full story from Visual Capitalist         Regulatory Roundup Stories from and about the FDA Clinical Lactation Studies               Klick Ideas Exchange   — idx.klick.com     Have you explored IDX yet?   Featuring a wide selection of the most relevant videos, original interviews, articles, and POVs, Klick Ideas Exchange (IDX) provides industry leaders with tailored insights to support innovative and exponential thinking. Sign up or log in today and explore all the new features.   — Browse all ideas                Klick Health, 240 W 40th St, 12th Floor, New York  NY, 10018  USA  You are receiving this email because you subscribed to our mailing list. Want to change how you receive these emails? Unsubscribe     © 2025 All rights reserved. Klick Health® is a trademark of Klick Inc. Privacy Policy |
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