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
FDA's New Crackdown: Balancing Truth in Pharmaceutical Marketing
A seismic shift is underway in pharmaceutical marketing regulation. Yesterday, the FDA fired a warning shot heard across the industry, announcing a massive crackdown on what they're calling misleading pharmaceutical advertising. With over 3,500 letters sent to manufacturers, this unprecedented enforcement action targets violations across all channels—traditional media, digital platforms, and especially social media influencer marketing.
For decades, we've watched regulatory oversight steadily decline. The numbers tell the story: from 120 warning letters in 2002 to just one in 2023. This created a perfect storm when combined with the rise of social media as patients' default health information source. A recent study found 88% of pharma-related social posts fail to meet fair balance standards—emphasizing benefits while minimizing risks. Even more concerning, algorithms amplify this imbalance by favoring positive content that drives engagement.
The implications reach across pharmaceutical organizations. While most brand teams already maintain strict compliance processes for official communications, the challenge lies in controlling third-party messaging, particularly from influencers who may genuinely love a product but fail to mention side effects or proper usage guidelines. For digital innovators, patient support teams, IT security experts, procurement officers, and executives, this enforcement wave demands immediate attention—not just to avoid penalties, but to restore and maintain public trust.
This moment presents an opportunity to reimagine pharmaceutical marketing through a lens of transparency. What if companies redirected even a fraction of their advertising budgets (reportedly up to 25% of total operating expenses) toward digital therapeutics, financial support solutions, and evidence-based patient education? The path forward requires greater transparency in partnerships, improved risk-benefit balance in all media, and an industry-wide recommitment to both the letter and spirit of FDA guidelines.
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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 Postscripts, the podcast exploring what happens after that first prescription. We cover the latest news and innovations in patient access, support, digital tools, hcp engagement and pharma marketing that we all hope drive better outcomes for patients. This podcast is for informational purposes only and does not constitute any medical advice, nor should it influence any clinical decision making. Patients should always consult their healthcare professionals. Welcome to the podcast. My name is Brian Carr. I'm from the Medisave team, although any opinions expressed here are my own and not those of Medisave or its partners. Hey, what's happened? Here is a warning letter that's being heard around the industry today.
Speaker 1:Over the past few decades, the lines between drug promotion, education and influence have grown increasingly blurred. But today one of the most urgent conversations is now happening within the life sciences industry centers in the US around the FDA's recent crackdown, announced yesterday, on what they're calling misleading pharmaceutical advertising, both direct to consumer and through emerging digital channels, especially social, and more on that in a bit. So for many years, the volume of regulatory enforcement on advertising practices by pharma companies has declined dramatically, and I have the stats on that in a minute. But in an unprecedented move, the FDA has announced a renewed commitment to monitoring and policing pharmaceutical promotions with the launch of a major campaign involving thousands of warning and letters sent to pharmaceutical companies. Commissioner of the FDA actually summed up the broader concern in a statement saying, quote for far too long the FDA has permitted misleading drug advertisements, distorting the doctor-patient relationship and creating increased demand for medications regardless of clinical appropriateness. Drug companies spend up to 25% of their budget on advertising. Still quoting here, those billions of dollars would be better spent on lowering drug prices for everyday Americans. End quote. So today, on PostScripts, we're unpacking the scope and implications of this crackdown, particularly for brand marketers, innovation teams and compliance leaders, patient access support teams, hcps, even IT and cybersecurity experts and particularly procurement officers and, of course, c-suite overall in the industry.
Speaker 1:So what's the scope of the crackdown? Well, the FDA announced a sweeping new enforcement initiative targeting deceptive, misleading or unbalanced, what they call pharmaceutical advertising. More than 3,500 letters, reportedly, were sent to manufacturers that the agency has identified as being in violation of fair balancing advertising guidelines. The letters were both formal, untitled notices generally and then enforcement-packed warning letters pointing to violations, they say, across multiple platforms TV and radio commercials. Print advertisements in professional journals and magazines. Sponsored web content display. Ads in professional journals and magazines, sponsored web content, display ads and particularly paid social promotion and influencer marketing content. So, according to the FDA's release communication guidance, the increase in violation really does stem from a spike in pharma advertising activity that prioritizes promotion over education or balanced information. So let's just take a clear look at what constitutes, in the FDA's mind, a misleading advertising.
Speaker 1:Under federal law, all drug advertising must comply with the following truth and advertising principles One, present a fair balance of risks and benefits. Two, provide adequate directions for use. Three, avoid overstating the drug's efficacy or scale of benefit. Four, disclose major side effects and any contraindications. Five, clearly communicate the approved indications and usage. And six, declare any financial ties in third-party endorsements or influencer promotions. And that's key. So, as the FDA and independent watchdogs have found, a 2024 study in the Journal of Pharmaceutical Health Services Research analyzed over a thousand pharma-related social media posts and they found 100% of the posts emphasized the drug benefits, only 33% mentioned potential harms or risks. 88% of them failed to meet FDA fair balance standards, according to the study.
Speaker 1:So the challenge there is unmasking that digital area of influence right. So one of the greatest challenges to the truth in advertising in 2024 and 2025 is this rise of social media as this default health information source. Patients, increasingly, are turning to platforms like Instagram, tiktok, youtube, reddit, facebook, not only for community but for treatment recommendations, real patient experiences and disease education. Unfortunately, many of the spaces are also becoming prime locales for unbalanced drug promotion disguised as organic or user-generated content from influencers. Right so the use of influencers sometimes they're paid, sometimes incentivized versions of patients really has made it incredibly difficult to distinguish some editorial testimony from strategic messages.
Speaker 1:And here's the challenge Several problems can arise. So there could be a lack of clear disclosure of financial relationships between influencers and their pharma companies, unless it's explicitly mentioned. Right, there may be personal anecdotes that may often misrepresent the overall clinical evidence or approved indications. Right so when influencers are just talking about how this medication affected them may be very compelling and true and factual, but that does not necessarily mean it's for the entire population. Right. Posts by themselves are going to selectively highlight treatment successes while ignoring the risks or eligibility criteria.
Speaker 1:So you can imagine just, even if the most balanced two pieces of social media content are released by an agency or a pharma company, meaning whether it's successes, both are balanced, showing successes, and one else is also showing successes and risk. You know risk. Both are the same, but the algorithm. May they step in and say, well, this ad talked about successes a little bit more or more prominently, or at the first half of it. Therefore it's getting more engagement. Therefore it's going to get shown more than one that may have bounced it out but maybe started showing risks first, or et cetera, et cetera. So you've got this not only a third-party vendor or influencer influencing the content, but also the fourth party we could even say algorithm stepping in and saying, well, I'm going to show this one more than the other one because it's just getting more engagement. Right, because it's more positive and showing successes. Right.
Speaker 1:So that blurring of boundaries has real-world impacts. As social media increasingly drives this public understanding of treatment options, it's really imperative that the pharma industry rises to the occasion, builds greater transparency, balance and compliance into all digital outreach. So think of the advertising budget as an arms race. That's happening, right. So pharma companies are among the biggest spenders in the United States in advertising. Typically, they'll spend more than $8 billion. I've seen higher estimates, too, on direct-to-consumer marketing in the United States alone. Right, that actually comes from Kantar Research. The figure amounts at approximately 20 to 25 percent of some companies' total operating budget, right, so compare that to investments in patient affordability and adherence solutions, evidence-based patient education campaigns. That imbalance does become glaring in some cases, right. So as the FDA had said, quote these billions of dollars would be better spent, in his mind, on lowering drug prices for everyday Americans. Right End, quote.
Speaker 1:So later, on top of that, that recent history of declining regulatory oversight. So you have these perfect conditions for a boundary pushing marketing strategies that some might consider predatory some. And how do we get here? Well, let's look at a timeline of that advertising oversight, and I promised you this. So the FDA has a long-standing mechanism for enforcing drug advertising standards, and from the 1990s through the early 2000s, the agency regularly issued 100-plus more warning letters per year, at least two per week, to what they thought were misleading drug advertising. And this is all in their annual reports, right? But in recent years the enforcement actions have seen a decline. So in 2002, again 120 warning issues a letter. That's more than two a week. In 2010, just eight years later, only 52 letters issued, averaging one a week. Right, so it's cut 50%. 2022, they go from 52 letters in 2010 to a decade later. In 2022, only four letters were issued. 2023, one letter is issued right 2024, no letters were issued. This is all from the FDA enforcement annual reports.
Speaker 1:Now you could say that's because the compliance has stuck. The pharma companies are adhering even more and they're getting it right and they know exactly what it takes and how to get through, and that is largely the case that I've seen, especially working with brand teams or brand marketers, procurement teams across the board. There are strict compliance and adherence rules for here's what the messaging has to be passes, medical, legal, regulatory review all the way across the board. The challenge may be in some of the social media influencers campaigns that frankly, they may be given here's a product, here's how to talk about it, here's what you can't say but then they riff for five minutes about a product or a solution and how great it is for them, and it may be completely honest. The challenge is it may be emphasizing the successes over anything. The person may not have had any side effects. Therefore, they don't get mentioned, right. So this decline in letters going out really does allow for more creative interpretations of advertising rules, particularly on some of the newer platforms and those technologies, especially when the regulations weren't even originally written to govern them in the 90s right, such as the TikTok videos and even hashtags, ephemeral content, ai-generated patient testimonials right, those are coming. So there's legal and ethical implications for pharma teams.
Speaker 1:Obviously, this new wave of enforcement it's not just a warning shot. It has deep ramifications for every department. Consider this right. Brand marketers must even doubly ensure all their promotional materials meet fair balance guidelines, and I will tell you they do. On every brand that we've implemented and talked through through the years, there are major reviews, legal regulatory compliance for anything official coming out of the brand teams, no question about it. So I think you'll see those standards, you know. I'd like to say not even be impacted, because they're already meeting those standards and every indication I've ever seen, right.
Speaker 1:But patient support teams need to provide educational outreach that helps patients understand risks, eligibility, treatment expectations. We may need to train patients that say, listen, if you're not seeing the mention of any how it is used, any mention of side effects or anything like that in whatever media you're consuming, we may need to educate them. That may not be approved by the FDA, right? Or there may be medications that, frankly, are over the counters, supplements that don't need to go to the FDA and it just says FDA has not approved these statements. We've seen that little fine print, right? So it may need patient support teams to really educate. Hey, I've heard about this new medication. Well, was it FDA approved? Are you seeing any indications of side effects being mentioned or indications on what it's good used for, et cetera, et cetera, right?
Speaker 1:Digital innovation leaders you're going to have to be able to evaluate any influence of programs you have in digital campaigns for alignment with those disclosure rules. Again, I think the digital campaigns that I've all seen very strict compliance with brand innovation, brand teams, innovation teams, legal teams across the board. I think it's in environments where the full control may not always be there, just because someone's taken it and gone on their own in maybe a good-natured way. They're not trying to violate any rules, but they're talking about positives without mentioning, maybe, any of the side effects, right? So think of it that way. It and security teams need to review all those systems that automate communications and ensure compliance in real-time personalization tools, targeted ads that's true. Procurement offices you're going to need to assess your vendor partners, agencies, influencer platforms for regulatory reliability. Frankly, I can see procurement and legal teams just telling marketing teams no more influencers. I can just see it happening. Right.
Speaker 1:Pharmacy suite carry executive responsibility, of course, for the ethical commercial practices and long-term reputational risk they do already anyway, right. So there will be a lot of trust through transparency. There's opportunity here, right? So when you're standing at a crossroads and drug advertisements can really raise condition awareness in a positive way and support discovery of life's changing treatments, the ultimate mission must always stay patient-centered, which it largely is, but restoring and keeping that public trust and, frankly, market share is going to require embracing those following shifts greater transparency in the influencer partnerships, if you're still using them, and sponsored content. Improved risk-benefit balance in all media, especially social. More education, fewer exaggerations, if there are any.
Speaker 1:Industry-wide recommitment to the spirit, not just a letter of FDA guidelines. Industry self-regulation, when done comprehensively, proactively, is one of the most powerful tools in preventing future scrutiny and legal exposure. So what's going to happen next? Well, according to the FDA, there's a wave of initial enforcement just at the beginning. Ongoing digital surveillance tools are being developed to track violations in real time. Companies found in repeated noncompliance may face fines, forced retractions, product reviews or even litigation.
Speaker 1:What's also interesting to note, though, is in the US administration's message. This summer, you may recall they sent out most favorite nation message demands. Remember there were letters written to 17 pharma companies about how US prices for patients, particularly those in Medicare, need to be no higher than those used at other developed countries. In that executive order was a third or fourth bullet point which said by the way, direct-to-consumer medication programs in the US can be greatly enhanced and negate the rules for most favored nation pricing if it's going direct-to-consumer. So there would be some influence where the administration would allow more direct-to-consumer flexibility on pricing if it's going direct-to-patients, right. So they opened up sort of that D2C market there, right from one end of it as well.
Speaker 1:So here we have more guidance that well, even if you're going D2C, you really have to train your teams, vet your conduct, clarify your policies, especially if you're using any influencers in emerging digital formats, so you don't appear on the FDA's radar for any violations or warnings or anything like that which, frankly, could even come from your competitors, as we all know, right. Well, they're looking at what you're putting out there and if they see someone step over the line it's not unheard of that you may get reported in the FDA by some competitors. So in today's digitally transformed landscape, the world sees and shares faster than ever before. The regulatory lag, though, is catching up. Right, so they mentioned the use of AI tools, for example in the FDA, to really catch things more in real time. Right, so that industry's response can't afford just to be reactive.
Speaker 1:There is a time here to be proactive and really reassess and make sure everything is in compliance. Right, so you know, we did begin this conversation today with a quote from the FDA quote drug companies spend up to 25% of their budget on advertising, end quote. Well, what if it would mean you take a fraction of that and puts it towards digital therapeutics, financial support solution, evidence-based patient education, after the script is written, that then informs, obviously, reimbursement rates and federal programs about the efficacy of medication claims? Right, and as healthcare marketers, brand leaders, digital innovators, access champions, we all have the opportunity and the responsibility to shape a more transparent and equitable treatment landscape. Let's have this wave of FDA enforcement be a catalyst, not only to make sure all our compliances are elevated, but the connection with patients and providers really is rooted in trust, accuracy and value.
Speaker 1:I'll list the sources to all this information in the show notes. Again, if you're into marketing, innovation, it, access, procurement, leadership roles, it really is that moment to re-examine the messages put into the world. Patients consuming them are really listening more closely than ever before in channels that maybe we haven't thought of as deeply as you have in the past with print materials. So thank you for joining us on Postscripts. If you found this conversation valuable, please follow and subscribe for more insights as we talk about that intersection of pharma tech and patient impact. Until next time, keep looking forward. The real work begins after that script is written.
