This blog is part of A Brave New World: State of the Industry series on modern market dynamics influencing the life science industry.

The Highlights

• FDA plans stricter oversight of direct-to-consumer ads, with a focus on TV.
• Life sciences firms should prioritize transparency, evidence-based messages, and diverse media.
• New rules require greater accountability, urging brands to review patient and HCP outreach.
• Digital and therapeutic complexity are fueling precision marketing strategies, rooted in behavioral insights, customer needs, and clinical relevance.
• Aligning patient education with HCP engagement and real-world data helps future-proof campaigns.
• Omnichannel flexibility is essential for trust and informed care in fast-changing healthcare.

Introduction

On September 9, the administration took a notable step toward fulfilling its campaign pledge by issuing a widely anticipated announcement reaffirming its commitment to enforcing established standards for direct-to-consumer (DTC) pharmaceutical advertising, particularly in television media (although not necessarily limited to this channel). Rather than signaling an imminent overhaul, the agency’s stance suggests heightened scrutiny and a renewed focus on ensuring compliance with current guidelines. While the full scope and enforcement approach remain uncertain, the outcome could range from the introduction of incremental guardrails to more substantive restrictions. For now, the focus appears to be on regulatory vigilance rather than sweeping reform—an approach reflected in the initial wave of Food and Drug Administration (FDA) enforcement letters issued in the days following the announcement¹.

Led by President Donald Trump and strongly backed by HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, the announcement marks a significant shift in how pharmaceutical companies communicate with the public moving forward. The FDA’s formal statement² outlines a proposed regulatory framework aimed at enhancing oversight of drugmakers’ presence in paid media, signaling a new era of accountability and transparency in healthcare advertising.

Read the full announcement here: FDA Launches Crackdown on Deceptive Drug Advertising | FDA

Advocates for the ban argue that DTC advertising has contributed to increased medicalization while placing corporate interests above public health³. The FDA’s initiative to address the “adequate provision” loophole is positioned as a renewed commitment to transparency:

Although the proposal does not implement an outright DTC ban, likely to mitigate potential First Amendment legal challenges from the pharmaceutical sector and related industries, it signifies a substantial change in the way drug companies interact with the public through promotion. Much of the focus of industry reactions has been on the uncertainty of the future presence of pharmaceutical advertisements on television networks, which rely heavily on pharma ad revenue-, with $5.15 billion in spend in 2024 alone⁴. As a result of this potential shift, life sciences companies and their respective media agencies need to rethink their outreach strategies.

Embracing Innovation through Data-Driven, Precision Marketing

Disruption, while often viewed as a challenge, can be a powerful catalyst for innovation. As highlighted during the IQVIA Digital Innovation Summit⁵, the life science industry is increasingly investing in utilizing digital channels to connect with their audiences, with an expected digital advertising expenditure as an industry of over $23 billion in 2025, up 33% from levels observed in 2022⁶. As media consumption habits continue to evolve, channels like digital audio and podcasts, social media platforms, and online video/connected TV (CTV) are no longer just emerging alternatives; rather, they are powerful engines of modern marketing. These platforms offer distinct advantages for brands, agencies, and publishers, including real-time analytics, dynamic campaign optimization, and personalized storytelling at scale. Market leaders are leveraging these capabilities not simply to keep pace, but to accelerate smarter, more effective audience engagement.

This transition is not solely a reaction to policy initiatives in Washington or the rise in prominence of digital channels. As more specialized therapeutics are introduced each year, this also signals a broader change in industry communication strategies to connect with smaller, specialized patient populations. For products designed to address increasingly specific patient segments, precision marketing has become more paramount. Brands implementing strategies designed to deepen omnichannel precision and personalization are positioned to adapt effectively to dynamic regulatory and policy changes.

Continuing to Support Patients in a Changing Environment

One of the most pressing concerns surrounding proposed changes to DTC pharmaceutical advertising is the potential impact on patient awareness, engagement, and timely access to care. DTC campaigns, particularly those broadcast on high-reach platforms like linear television, often serve as a critical first point of exposure to treatment options. This includes therapies for underdiagnosed, stigmatized, or rare conditions, as well as first-in-class innovations that may otherwise remain unfamiliar to the general public.

Without these awareness-building touchpoints, individuals may be less likely to seek timely medical advice, potentially delaying diagnosis and treatment. For at-risk or underserved communities, where access to healthcare is already constrained, public-facing disease awareness through mass media can be a vital lever for improving health outcomes.

Even the FDA has acknowledged the value of responsible DTC advertising. In a November 2023 Federal Register notice, the agency stated that “evidence shows that DTC ads inform important consumer decisions about healthcare.⁷” The same report noted that such advertising can prompt individuals to visit their healthcare providers (HCPs), ask more informed questions, and engage in discussions about sensitive health issues.

When executed responsibly, DTC advertising empowers patients to take a more active role in their healthcare journey. Limiting these opportunities may risk diminishing patient agency by reducing the flow of accessible, educational information that supports shared decision-making. Proponents of DTC advertising are quick to remind us that paid messaging is key to fostering informed engagement between patients and providers by “enhancing public awareness and encouraging more active participation in healthcare decisions”⁸ and even help to promotes early engagement with HCPs.⁹

HCP Personalization: A Strategic Imperative in Closing the Medical Evidence Gap

The recently proposed changes in healthcare communications are occurring during a period marked by significant growth in both the volume and complexity of new treatments entering the market. This expansion has increased (and is expected to continue to increase) the variety of options available for patient care. Although these innovative therapies offer promising prospects for patients, they also introduce greater complexity, resulting in additional research and administrative responsibilities for clinical care teams.

Over the past five years, the pharmaceutical landscape has undergone a profound evolution, marked by a surge in the launch of orphan drugs, precision medicines, and other specialized therapies. These treatments often target smaller patient populations and are characterized by complex clinical protocols, high costs, and sophisticated delivery mechanisms—factors that can challenge even the most experienced clinicians to stay current. In 2024, 72% of newly launched drugs carried an orphan designation, up from 51% in 2019¹⁰. Meanwhile, specialty medicines, which address chronic, rare, or complex conditions and often require intricate treatment, distribution, and patient management, accounted for 93% of all U.S. launches in 2024, the highest proportion in the past five years¹⁰. This shift underscores the growing complexity of the therapeutic landscape and the need for more nuanced, informed engagement across all healthcare stakeholders.

This complexity contributes to what is known as the “medical evidence gap”. This gap is exacerbated by the sheer volume of published studies, guidelines, and real-world evidence generated daily. With administrative and research burdens often cited to be among the contributors to physician burn out¹², it is therefore essential for industry to design systems to help alleviate these concerns. Addressing questions of physician time and capacity affords professionals the opportunity to spend more of their time focused directly on making informed patient care decisions. Brand strategies designed for efficient delivery of evidence-based information at the right time reduces the overall burden on the health system.

Strategic Imperatives for Future-Proofed Healthcare Communications

The collective response of life sciences organizations, along with media agencies, data providers, service partners, and other stakeholders, to regulatory scrutiny and persistent uncertainty will significantly influence the evolution and trajectory of DTC marketing within the sector. The traditional playbook, often centered around linear television and broad-based awareness messaging, was already being reexamined. Additional considerations under the lens of compliance and transparency will continue to accelerate the pace of change.

Success in this environment requires strategic foresight, operational agility, and strong ethical standards. As IQVIA works in support of our clients in planning for the future marked by the potential of continued regulatory uncertainty, there are several strategic areas of focus that can help mitigate risk and reduce exposure to potential shifts in policy. By proactively addressing these priorities, ranging from compliance infrastructure to media channel diversification, organizations can build resilience and maintain continuity in their marketing and communications efforts.

Regulatory scrutiny and public expectations are converging around a central theme: transparency backed by evidence. The U.S. Department of Health and Human Services (HHS) has emphasized that “trust in evolving health information technologies can best be established with openness and transparency about the policies, procedures, and technologies that affect how individuals’ health information is used.¹³”

In the context of healthcare communications, successful brands can take steps towards:

1. Integrating Real-World Data (RWD) and Real-World Evidence (RWE) into Campaign Planning

   Using RWD and RWE allows brands to tailor messaging based on actual patient experiences, treatment outcomes, and usage patterns. This not only enhances relevance but also provides a defensible foundation for claims within the messaging itself. Incorporating these data sources into campaign strategy supports more personalized, evidence-based communications that resonate with both patients and providers.

   Credibility and compliance go hand in hand and ensuring that messaging aligns with FDA-approved labeling is foundational, not only to meet regulatory requirements but to maintain trust with both providers and patients. However, brands can go further by incorporating supplementary data sources such as peer-reviewed studies, registry data, and real-world evidence to clarify complex concepts and enhance consumer understanding. This approach bridges the gap between regulatory rigor and audience accessibility, making scientific information more actionable and relatable.

   Transparency in risk-benefit communication is equally critical. As both regulators and the public demand greater clarity, brands must proactively communicate risks, benefits, and indications in a balanced and comprehensible way.

   Marketers should embed transparency and scientific integrity into every stage of campaign development. By aligning with regulatory standards and enhancing clarity through credible data, brands can build trust, foster informed decision-making, and differentiate themselves in a competitive and highly scrutinized marketplace.

2. Beyond Broadcast: Building Smarter, Resilient Healthcare Campaigns

   Healthcare marketers are constantly reassessing how and where they engage audiences. With traditional formats- particularly linear television- under renewed regulatory scrutiny and declining reach, digital platforms offer more targeted, measurable, and flexible opportunities for connection.

   Diversifying across connected TV (CTV), digital audio and podcasts, social media, endemic platforms, and programmatic display is no longer just a risk mitigation tactic, it’s a strategic imperative for maximizing reach and relevance. Messaging becomes more impactful when activated thoughtfully, aligned to audience behaviors and needs, and adaptable to market dynamics.

   To succeed, brands should prioritize channels and partners that offer:

   • Precision targeting based on behavioral insights and clinical relevance
   • Real-time data and optimization to adapt messaging dynamically
   • Cross-channel attribution to understand how each touchpoint contributes to engagement and outcomes

   Relevance, agility, and accountability are the new currency in healthcare marketing and these capabilities help ensure that marketers are able reach the right audiences in a compliant way, adapt in real time, and maintain continuity amid uncertainty. But diversification alone is not enough—brands that embed scenario planning into their strategic cycles, align cross-functional teams around contingency frameworks, and leverage predictive analytics to anticipate shifts will be best equipped to respond swiftly and intelligently to unforeseen challenges. In today’s dynamic environment, preparedness isn’t just prudent, it’s a competitive advantage. Taken together, a diversified media strategy and proactive scenario planning position brands not just to weather change, but to lead through it.

3. Balance Patient and HCP Engagement for Holistic Impact

   A high-performing healthcare marketing strategy requires more than reach- it demands relevance, credibility, and alignment across all stakeholders in the care journey. A dual-focus approach that integrates patient-facing campaigns with HCP engagement ensures that messaging is both clinically grounded and emotionally resonant. While DTC advertising raises awareness and prompts action, HCP-directed initiatives, such as peer-to-peer platforms, clinical education, and branded or disease awareness campaigns, reinforce scientific credibility and support informed decision-making.

   When patients are informed and motivated by consumer-facing content, and providers are simultaneously engaged with aligned clinical narratives, treatment decisions become more collaborative and effective. In order to best capitalize on this, marketers should design integrated engagement strategies that connect the dots between patient education and provider influence. By aligning messaging across both audiences, brands can foster shared decision-making, improve adherence, and deliver measurable outcomes in an increasingly complex healthcare ecosystem.

Conclusion: Resilience Through Innovation

The regulatory and promotional landscape will continue to evolve. It is essential to recognize that while the tightening of rules around DTC pharmaceutical advertising may be the end of an era, it also represents a strategic inflection point. The life science industry is being presented with a powerful opportunity to reimagine how to connect with patients and professionals in ways that are not only deeply meaningful but also compliant.

By embracing data-driven precision, ethical AI practices, and deeper omnichannel personalization, organizations can build trust, foster authentic relationships, and ultimately drive better health outcomes. Those who lead with adaptability, transparency, and patient-centricity will navigate current and future regulatory shifts and define the next era of credibility, and ultimately effectiveness, in healthcare communications.

Now is the time to lead with purpose. Reassess marketing strategies, deepen investment in responsible innovation, and reaffirm commitment to ethics, empathy, and integrity. Together, the industry can envision new models of engagement- ones that close the medical evidence gap for healthcare professionals, empower patients with purposeful precision and ensure that their time together in the office results in the optimal care decisions that improve lives.

Leverage the full potential of IQVIA’s robust datasets and advancements in technology to deliver communications that are relevant, timely, and impactful. Create a world where healthcare marketing is not just compliant, but truly transformative.

Contact your IQVIA representative for more information.

¹. Park A. FDA Targets Big Pharma in Deluge of Marketing Letters. Fierce Pharma. Accessed September 22, 2025. https://www.fiercepharma.com/marketing/fda-targets-lilly-novartis-bms-and-more-deluge-marketing-letters
². FDA Launches Crackdown on Deceptive Drug Advertising | FDA. Accessed September 22, 2025. https://www.fda.gov/news-events/press-announcements/fda-launches-crackdown-deceptive-drug-advertising
³. Makary MA. The FDA’s Overdue Crackdown on Misleading Pharmaceutical Advertisements. JAMA. Published online September 12, 2025. doi:10.1001/jama.2025.18197
⁴. Q1 TV Transparency Report: Ad-First Insights to Steer Strategy. Accessed September 22, 2025. https://www.ispot.tv/hub/resources/free-reports/q1-tv-transparency-report/
⁵. Summit Series: Ep. 2 Harnessing CTV Advertising to Engage Modern Audiences and Drive ROI. Accessed September 22, 2025. https://www.iqviadigital.com/resources/podcasts/summit-series-ep.-2-harnessing-ctv-advertising-to-engage-modern-audiences-and-drive-roi
⁶. Pharma accounts for nearly 90% of the broader industry’s digital ad spending. Accessed September 22, 2025. https://www.emarketer.com/content/pharma-accounts-nearly-90-of-broader-industry-digital-ad-spending
⁷. Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format. Federal Register. November 21, 2023. Accessed September 22, 2025. https://www.federalregister.gov/documents/2023/11/21/2023-25428/direct-to-consumer-prescription-drug-advertisements-presentation-of-the-major-statement-in-a-clear
⁸. Bhole A, Dhandore A, Chormale A, Navale S, Chougule DN. Assessing The Effects of DTC Advertising on The Pharmaceutical Market. Int J Pharm Sci. 2024;02(11). doi:10.5281/zenodo.14259870
⁹. Sullivan HW, Aikin KJ, Berktold J, Stein KL, Hoverman VJ. Direct-to-Consumer Prescription Drug Advertising and Patient-Provider Interactions. J Am Board Fam Med JABFM. 2020;33(2):279-283. doi:10.3122/jabfm.2020.02.190278
¹⁰. Global Trends in R&D 2025. IQVIA Institute for Human Data Science. March 26, 2025. Accessed September 22, 2025. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/global-trends-in-r-and-d-2025
¹¹. Mack C. A Co-Intelligent Future: How AI Can Augment Human Experts in Healthcare and Life Sciences. Modern Healthcare. September 1, 2025. Accessed September 22, 2025. http://www.modernhealthcare.com/providers/mh-how-ai-can-augment-human-expers-in-healthcare-and-life-sciences/
¹². Khullar D. Burnout, Professionalism, and the Quality of US Health Care. JAMA Health Forum. 2023;4(3):e230024. doi:10.1001/jamahealthforum.2023.0024
¹³. Openness and Transparency Principle. Accessed September 22, 2025. https://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/understanding/special/healthit/opennesstransparency.pdf