Postscripts Rx
Conversations Beyond the Prescription. Where pharma, HCPs, life science and digital health solutions meets patients—after the script is written. Conversations on digital health, engagement, and real-world impacts that are re-writing the future of patient engagement.
Postscripts Rx
DTC Advertising at Risk? Not So Fast
The pharmaceutical advertising landscape stands at a crossroads as bold new regulatory initiatives threaten to upend decades of established marketing practices. This week, the administration announced plans directing the FDA to reconsider the 30-year-old guidelines that have enabled the modern era of direct-to-consumer pharmaceutical advertising.
At stake is a 1997 policy change that revolutionized pharmaceutical marketing by allowing companies to provide abbreviated risk information during television advertisements while directing viewers elsewhere for comprehensive safety details. This seemingly small accommodation transformed pharmaceutical promotion, creating the familiar format of medication commercials that has dominated airwaves for decades. With industry spending reaching $8.1 billion in 2022, the potential impact of regulatory reversal cannot be overstated.
Yet the path to implementation remains fraught with obstacles. FDA regulatory changes follow strict procedural requirements that historically take years to complete. The pharmaceutical industry's robust legal resources and First Amendment protections provide formidable defense against aggressive regulation. Meanwhile, the promotional landscape has evolved beyond traditional oversight, with social media influencers and telehealth platforms creating regulatory gray areas. The most forward-thinking pharmaceutical marketers are already pivoting toward digital patient support tools that enhance medication adherence while generating valuable outcomes data that demonstrates measurable value to stakeholders.
Whether you're a pharmaceutical marketer navigating this uncertain landscape or simply curious about the forces shaping healthcare communication, this episode provides essential context for understanding what's at stake. Subscribe now and join our next conversation exploring how AI-driven personalization is transforming patient experiences in digital health.
PostScripts Rx is not intended to constitute medical advice, nor is it intended to influence prescribing decisions or any other medical or clinical decision-making. All medical and clinical judgment and decision-making, prescribing decisions, and all related considerations remain exclusively the responsibility of providers and patients.
Welcome to Post Trips, the podcast exploring what happens after that first prescription. We cover the latest innovations in patient access, support, digital tools, hcp engagement and pharma marketing and innovation that we all hope drive better outcomes for patients. This podcast is for informational purposes only and does not constitute the giving out of any medical advice, or nor should it be influencing any clinical decision making. Patients should always consult their healthcare professionals. Welcome to the podcast. My name is Brian Carr. I'm from the Medisafe team, although any opinions expressed here are my own and not necessarily those of Medisafe or its partners. So what are we talking about here? Yesterday's news that there'd be a crackdown on pharma D to C, direct to consumer ads Is this a regulatory shift in sight? Well, this week the US administration under President Trump announced a bold new initiative targeting pharma advertising specifically, in order to the FDA to revisit, potentially reverse, the current direct-to-consumer advertising guidelines really, that have stood for nearly 30 years. The announcement has triggered both curiosity and concern across the pharma industry. So, while regulatory proposals they've been floated before, this development implies again a significant group of ramifications for how brand marketers, innovation teams, even patient engagement strategists, operate in the field, especially here in the US. So in this episode we're going to delve into what the administration is proposing and the legal and regulatory hurdles it faces and what it really means for pharma marketing teams and that possibility of oversight, and expanding to social media influencers and telehealth platforms. We're also going to close the loop by highlighting technologies enabling compliant patient engagement, including tools like Medisafe and others that really support patient adherence, engagement beyond the prescription. That can help with engagement and efficacy metrics that are needed if pharma sometimes wants to prove its case about advertising being so beneficial to patients.
Speaker 0:Here's the news you know there was a presidential push to rein in pharma ads. That happened this week. The US administration directed the FDA to reconsider policies that do allow, right now, for short-term and short-form side effect disclosures in televised drug ads. Right, the aim, according to the administration, is to shut down what they or some people say is a loophole exploited by drug companies to gloss over safety risks. Right, they'll announce, for example, and add some side effects and for more information, go to Reader's Digest for more things like that. Well, this would reverse some of those regulatory challenges made in 1907 that allowed the companies to really kind of summarize the risk information during TV ads and direct consumers to a website or a magazine ad or other written material for a more comprehensive explanation. This is 30 years old. Even so, the change was pivotal in making broadcast drug marketing feasible, both in terms of production logistics and costs. But now, as part of the administration's drug pricing reform strategies, reverting the rule could substantially raise the bar for what qualifies as compliant direct-to-consumer advertising, effectively reshaping that toolbox that marketers have on the brand teams. Right, you know the Associated. After this was announced this week, the Associated Press reported well, this is very much a not so fast situation. Why, and they actually said, the implementation of this may be years away. And here's why you know, reversing that three decade old precedent is complex.
Speaker 0:The FDA policymaking doesn't happen overnight. The agency has to follow formal procedures for regulatory changes. Processes involves initiating rulemaking procedures, publishing proposals for public comment, allowing time for industry challenges and, yes, court appeals and litigation. So, for example, the FDA recently finalized updated guidelines for more transparent language in drug ads. That process took 15 years. So even the Associated Press said if the administration attempts to accelerate the process or bypass those normal procedural steps that have set precedent, that could open the door to legal challenges. Right, so court rulings in turn risk establishing precedents that could narrow the FDA's authority even further. Right, so legal challenges are probably likely.
Speaker 0:Historically, the FDA has exercised caution in pursuing aggressive ad reins. There's reasons for that. In several cases the agency has deferred enforcement rather than risk unfavorable court rulings that actually restrict officially restrict its influence. Right? So such caution usually reflects a strategic desire to protect the FDA enforcement capabilities, which could be eroded if boundaries are then tested in the legal system. So, moreover, the pharma industry is protected under the First Amendment rights as long as its advertising remains quote truthful and not misleading. So that is the truthful or not misleading DTC advertising is protected under the First Amendment. Has documented evidence of advancing patient awareness and engagement. This comes from the Pharma lobbyist group at Pharma, and this was in April 2024.
Speaker 0:So the challenge here is current DTC trends. Right, it's a different landscape from the 2000s of 30 years ago, former FDA officials. They also point out the pharma advertising landscape has already transformed in the past 30 years, when the ads were loud, fast-moving, often used distracting imagery to obscure critical safety text or voiceovers. Today, the drug companies largely abandon those egregious tactics to result as a more measured environment. This mitigates some of the urgency around regulatory changes, a fact that could weaken the political will to push change through. There's data from Kantar Media recently showing that DTC pharma advertising really sped, really peaked post-COVID in 2022 and beyond it sort of plateaued. There were over 8.1 billion in ad buys in 2022. And it's come pretty stabilized there as consumer media really has habits, have shifted into digital formats, and that's a Kantar study that came out in 2023.
Speaker 0:Honestly, there's also been staffing cuts at the FDA, particularly in the advertising division. You know there's staffing cuts at the division. It's the very department responsible for issuing the warning letters to noncompliant advertisers and following up. So this means, even if new restrictions are approved, the actual human resources needed to execute this widespread enforcement just currently aren't in place the way they were. So, with fewer people on the beat, the agency would likely need to prioritize the major infractions which may embolden some companies to continue current advertising practices until compelled otherwise. Again, in their case, they certainly are advertising legally and transparently with the campaigns they're doing. Now I can tell you in our experience all the campaigns are strictly enforced with medical, legal, regulatory reviews, anything that talks about the products or mentions them in any way. You know brand marketers will say we're already doing and complying with all those rules. There are no egregious things that FDA people may point out from 30 years ago, right?
Speaker 0:So even the FDA commissioner also raised concern about how pharma products are increasingly promoted on platforms that fall outside the agency's jurisdiction jurisdiction, particularly social media and even telehealth companies. Right, so you've got Instagram, now TikTok, youtube. They've become hotbeds for health related content. You've got patient influencers, many of whom are paid or incentivized by pharma brands, completely on the up and up, but they often endorse products, but they may have insufficient disclosure of risks or side effects and that may not be intentional. Maybe an influencer talking about I have this condition and I take this medication. It's working great for me, right, and if they're disclosing, I am being compensated by the pharma company.
Speaker 0:The challenge that some critics are saying is well, that may skew right the conversation to be more about the success of the medication and not being fully transparent on what the side effects may be. If that influencer for more success very successful in the medication, it's upbeat, click on that more, despite its very nature, those algorithms for what's getting shown and clicked on and watched more success stories, for example, as opposed to negative stories on side effects. They may, by its very nature, just be getting a skewing of the fair and balanced approach. So maybe, beyond the pharma marketers and brand managers, even the on the level of influencers, it's just a nature of what's happening out there.
Speaker 0:And this question, when the FDA actually has any jurisdiction, given the free speech rights and commerce rights, to actually curtail what's happening on influencer platforms? Right, certainly they can give guidelines and guidance, but to actually take it to court, that could be something that may actually reduce their footprint if a ruling goes against them on ways that people want to talk about their own medical experiences. So some influences, clearly, are paid directly by pharmaceutical companies. Others simply share positive experience, right, in the hopes of drawing attention from sponsors. That may happen. Meanwhile, newer entities like telehealth platforms, specialty pharmacies they sometimes claim an exemption from FDA guidelines because they do not fit the traditional definition of a drug manufacturer, right? So earlier this year, a high-profile Super Bowl ad promoted a compound GLP-1's weight loss medications, showcasing benefits while, frankly, omitting some standard risk information. That could have been argued it was a clear breach of FDA advertising norms. Yet action is still remaining pending, right. So there's a legislative wildcard here, right, recognizing the gap, a Senate bill was actually introduced in 2023, aimed at extending FDA oversight to include influencers and non-traditional health platforms like telehealth companies. This could formally bring social media promotion under the agency's scope. However, the bill has stalled, hasn't received a hearing, making it unlikely to influence strategy. Barring the bipartisan momentum ahead of the next election cycle, perhaps, but there may be bigger impacts ahead for pharma.
Speaker 0:You know communication strategies. What's it all mean? Well, tv definitely remains influential, but regulatory uncertainty may discourage large scale investments. Social media promotions are outpacing regulations, but risk misalignment with FDA requirements may be risky, right, so internal review teams are probably going to be revisiting evolving FTC disclosure rules and they may consult legal throughout campaign design. Now, right.
Speaker 0:Future advertising strategies will likely balance mass market reach with these hyper personalized support tools, right, you know, I can imagine, for example, legal teams are saying no more influencers. Right, if it really gets to a point where the FDA is cracking down on influencer ads social media beyond the control, it could be simply. Well, if patients want to talk about it on their own and their positive experiences, that's fine. It's pharma, it's just people talking as if they were in a cafe If pharma is not part of it or officially compensating, right, so they might be like. Let's just reallocate that social media influence and budget elsewhere, right.
Speaker 0:But there is opportunity here, right. Digital support tools. Regulatory changes are percolating. Brand teams can gain real traction you know they are now by investing in tools that build trust, guide treatment, provide compliant patient journeys, especially those that sidestep mass media risks. You know. Digital companions, medisafe, other platforms you know, gives that robust patient engagement platform with medication, adherence reminders, two-way communication, educational content. Not only do they align with FDA compliance expectations but also can help those brand teams demonstrate measurable value to payers and providers. Why? Because we have the data on the adherence rates, the efficacy rates, right, the persistence rates on certain medications that could help them even qualify for better reimbursement rates when it goes to the state-sponsored and federal-sponsored medical programs, right.
Speaker 0:So you know the Trump administration's directive to really tighten FDA drug rules. It's significant, but it can be fraught with legal and operational, actual tactical hurdles. Historical precedent suggests any reversal of advertising policies could take many years and face likely industry pushback. We have FDA staffing cuts that are limiting immediate enforcement capacity. I will say, though, the influence of marketing remains sort of this wild west of pharma promotion very personalized, very effective. The challenge there is you know the guidelines, or all you need is one or two that become the example and case study from an FDA perspective on them claiming hey, not enough of side effects were talked about in this two-minute influencer ad, which is sponsored by Pharma. Right, so you don't want to be that example case.
Speaker 0:So where do we go from here? Well, the mission for Pharma brand and innovation teams is clear continue engaging patients in ways that are evidence-based, regulatory compliant and impactful, right? So the other thing is, you know, if it ever goes to a court case or there's an appeal going on, data is showing, by the way, because of these ads or because of this marketing, people subscribe to the medication. They stayed on it longer. We have data showing this, right, stay on it longer. Therefore, it actually reduces, you know, it increases the impact of medication, reduces bad things happening, and you know, and the efficacy of the medication and the education provided for patients can really be a benefit that actually support. This is why the education and the ads spends are actually in the nation and patient's best interest, right?
Speaker 0:So while these political wins court decisions may shape this future landscape, the best hedge is really to focus on efforts with value-rich strategies, personalized platforms, education-first communication, digital companions it's this forward-looking go-to-market model, regardless of how the DTC ad reform plays out. The next time we'll explore how AI-driven personalization in digital health is transforming onboarding and titration experiences for patients, so be sure to tune in. Thank you so much for joining us here on Postscripts. If you found this conversation valuable, please follow or subscribe for more insights at the intersection of pharma tech, patient impact and innovations. Until next time, keep looking forward. The real work begins after that script is written.
