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
How FDA's 2025 DTC Ad Enforcement Reshapes Patient Communication
Pharmaceutical marketing stands at a critical turning point following the FDA and HHS's September 2025 coordinated crackdown on direct-to-consumer prescription drug advertising. This watershed moment marks an unprecedented shift in enforcement, with regulators issuing approximately enforcement actions—including warning letters to industry giants like Eli Lilly, Novo Nordisk, and telehealth providers.
The heart of this regulatory action targets what the FDA calls the "adequate provision loophole" that has long allowed marketers to shift detailed safety information away from prime advertising space. The new enforcement environment demands a fundamental recalibration: consumers must receive clear, balanced safety information at the exact moment they encounter benefit claims, not buried in fine print or on separate websites. This raises significant challenges for traditional advertising channels like television, where limited time has historically pushed risk information to the margins.
However, this regulatory shift creates a compelling opportunity for digital health platforms and patient support technologies. Unlike time-constrained TV spots, these channels can deliver step-by-step information tailored to individual patient journeys, embedding precautions alongside benefits in formats that ensure comprehension. For pharmaceutical marketers navigating this new landscape, success requires immediate campaign audits, earlier collaboration with Medical Legal Review teams, and a strategic pivot toward channels that naturally facilitate balanced information delivery. The FDA's message is clear: put patients first while telling the complete truth about both benefits and risks. Those who embrace this challenge will not only achieve compliance but build stronger, more transparent relationships with the patients they serve.
Follow or subscribe to Postscripts for more insights at the intersection of pharmaceutical innovation and patient impact. Share your thoughts on how these regulatory changes are reshaping your marketing approach.
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 the first prescription. We cover the latest innovations in patient access, support, digital tools, HCP engagement and pharma marketing that drive better outcomes. This podcast is for informational purposes only and does not constitute medical advice or influence clinical decision-making. Patients should always consult their health care professionals. Welcome to the podcast. My name is Kathy Zaremba and I am the Senior Director of Product Marketing at Medisafe, although any opinions expressed here are my own and not necessarily those of Medisafe or its partners. Let's dive in.
Speaker 1:September marks the winds of change in pharma marketing. For those of us in life sciences, marketing, procurement or abscess, the rules of the road for DTC advertising just changed, and fast. In today's episode, we'll unpack the FDA HHS crackdown announced this month of September 2025, what it means for brand marketers, agencies and procurement teams, and concrete steps to build campaigns that are resilient to the new enforcement environment that still deliver patient value. Here's what happened. On September 9, 2025, hhs and the FDA announced a coordinated effort to rein in the misleading direct-to-consumer prescription drug advertising. The initiative included an immediate enforcement push, roughly 100 cease-and-desist notices and more than 100 warning untitled letters posted to the FDA website, and a commitment to close what the agency calls the adequate provision loophole used to shift safety information off air. The agencies also signaled expanding oversight of social and digital channels and said they would require fuller safety disclosures in consumer-facing ads. Reporting on the move shows the FDA has already sent warning letters to a mix of major manufacturers and telehealth companies Coverage names like Eli Lilly, nova Nordisk and Hims and Hers among those receiving letters, and the agency posted numerous untitled and warning letters on its site dated September 9, 2025. The speed and scale of the action mark a clear shift from recent years, so let's talk about why this matters.
Speaker 1:What is the regulatory posture and intent? This is not a one-off PR show. The agencies are signaling a programmatic change, combining rulemaking to remove the adequate provision work grounds with aggressive real-time enforcement. The stated rationale consumers should receive clear, balanced and accessible safety information at the point they're hearing benefit claims, not buried elsewhere. That increases the regulatory bar for how we communicate the benefits to risks ratios to patients. Here are some concrete enforcement themes we're seeing From the recent letters and guidance.
Speaker 1:The top compliance problems remain familiar but are being enforced at higher volume and velocity. Failure to present fair balance these are benefit claims without understandable risk information. Overstatement of efficacy claims. That means implying broader effectiveness than the label supports, use of imagery, spokesperson statements or social posts that may mislead about safety, age groups or off-label use. And reliance on adequate provision redirects such as websites, phone numbers and so on, without ensuring the consumer actually receives the full safety context. So what does this mean for brands and agencies? These letters are not symbolic. We can expect tangible impacts like pulled or recut ads, paused launch timing, increased FDA follow-up and reputational fallout.
Speaker 1:Multi-channel campaigns like TV, social and influencers are all squarely in scope, especially social and telehealth ad placements that historically were less rigorously policed. That shifts how creative and legal must collaborate from ideation through execution. So how can we operationalize? What are some practical steps for brand teams Now? The obvious is immediate campaign triage. Audit active DTC assets like TV, paid social, influencer scripts, web landing pages and the like for fair balance, and avoid language that amplifies benefits without label support. Bring the MLR teams in earlier. Make MLR a required collaborator at concepting, not only at final sign-off. Pre-test for consumer comprehension. Move beyond click-through metrics and pre-test creative for whether consumers actually understand the benefit and the risk. So let's talk about where digital health fits into this.
Speaker 1:One of the biggest shifts here is what the crackdown means for channel strategy. Traditional TV advertising has always carried the highest visibility, but also the greatest risk. You've got 60 seconds to tell a story, and that often means benefit claims overshadow risks. That's precisely why the FDA is tightening guardrails. But this opens the door for digital health platforms and patient support technologies to play a bigger role. Unlike a TV spot, a digital tool can walk a patient through information step by step, benefit and risk, tailored to where they are in their treatment journey. These platforms can embed drug precautions, reinforce adherence reminders and provide conditioned education, all in a format that's interactive, trackable and accessible on demand. From a compliance standpoint, that's powerful.
Speaker 1:Digital channels allow for built-in balance, so risk disclosures don't have to compete for airtime. They can be surfaced alongside benefits at the right moment. Patient comprehension testing you can measure whether users actually understand what they've seen, and personalized engagement Information can be sequenced to the individual rather than crammed into a one-size-fits-all ad. In other words, while TV is being clipped back, digital tools offer a way forward. In other words, while TV is being clipped back, digital tools offer a way forward a channel that meets the FDA's call for transparency and accuracy, while still helping patients make informed choices and stay engaged in their care. So the bottom line is that the recent FDA HHS actions are a wake-up call, not an industry death knell. They force brands, agencies and procurement teams to do the one thing marketing should always do put the patient first while telling the truth. Thanks for joining us on Postscripts. If you found this conversation valuable, follow or subscribe for more insights at the intersection of pharma technology and patient impact. Until next time, keep looking forward. The real work begins after the script is written.
