Direct to Patient Marketing : A Tale of Two Territories
As advertisers in the US face mounting pressure and regulation, they’re looking across the pond for inspiration.
Direct-to-Patient (DTP) marketing in the pharmaceutical industry is undergoing significant transformation, shaped by evolving regulations, technological change, and shifting consumer expectations. But the rules about ads for drugs in the US are almost globally unique (only New Zealand shares such a relaxed regime). At the other end of the spectrum, the EU’s army of regulators requires of the pharma industry a bit of lateral thinking when it comes to educating the public. A comparison, then, a tale of two territories, when it comes to hyping medicine, might be instructive. The distinction between the approaches taken in the United States and the European Union underscores a broader debate about the balance between patient engagement and regulatory oversight. As advertisers in the US face mounting pressure and regulation, they’re looking across the pond for inspiration.
The long-anticipated appointment of Robert F. Kennedy Jr. as Secretary of Health and Human Services in February, was one among a number of big turning points for direct-to-consumer pharmaceutical advertising in the United States. Known for his vocal skepticism of the pharmaceutical industry and its influence on media and public health policy, Kennedy has always signaled his intent to challenge long-standing norms in drug marketing. While a full ban on DTC advertising would face constitutional hurdles due to First Amendment protections, his leadership is expected to bring heightened regulatory scrutiny, new restrictions, and fundamental changes to how pharmaceutical companies engage with consumers.
One of the most immediate concerns for the industry is the potential for tighter FDA oversight. Stricter requirements for advertising approvals, enhanced disclosure mandates, and limitations on promotional claims could make DTC advertising more cumbersome and less effective. The possibility of congressional action also looms, particularly in the form of new legislation aimed at restricting the advertising of newly approved drugs, echoing previous proposals that sought to impose only moratoria on certain campaigns. Even if a full ban proves legally unattainable, Kennedy could create significant obstacles by increasing red tape around pharmaceutical marketing, making compliance more costly and time-consuming.
Skepticism about direct-to-consumer advertising is nothing new. Concerns over misinformation, overprescription, and the undue influence of marketing on patient decision-making have led to increasing scrutiny from regulators over the years. The recently reintroduced Drug Price Transparency for Consumers Act signals a legislative shift toward requiring greater transparency in pharmaceutical advertising, a move that is likely to redefine messaging strategies and consumer engagement. In May 2024, the FDA introduced new rules about drug advertising on TV and radio. These regulations require that the risks of medications be presented as clearly as their benefits. The guidelines address common issues in drug advertisements, such as rapidly spoken disclaimers, small and hard-to-read text, and distracting visuals that divert attention from safety information. By ensuring that risk disclosures are easier to understand, the FDA hopes to create a more informed public capable of making better health decisions.
The impact of these new rules on the pharmaceutical industry is complex. While companies are now obligated to modify their advertisements to comply with these standards, experts remain skeptical about whether the changes will significantly alter how consumers engage with drug commercials. Even with clearer language and improved presentation of risks, these ads will likely continue to drive demand for prescription drugs, reinforcing the existing model where patients request specific medications from their doctors.
The industry’s substantial advertising budgets—totaling billions of dollars annually—suggest that companies will continue investing in ads that, while adhering to the new guidelines, remain persuasive and emotionally engaging. Additionally, because drug advertisements often feature medications with questionable therapeutic value compared to existing alternatives, critics worry that the new rules will not fundamentally change the inefficiencies in healthcare spending that arise from patients requesting heavily marketed but not necessarily superior treatments.
While the guidelines may lead to more readable, comprehensible advertisements, they are unlikely to disrupt the deeply ingrained role of pharmaceutical marketing in American healthcare. The broader question remains: will these changes genuinely help consumers make better-informed decisions, or will they simply refine the advertising playbook without altering its fundamental influence on drug consumption?
So if TV and radio ads are increasingly in the cross-hairs of regulators, why not ditch TV and radio? After all, most consumers experience advertising away from TV and radio. In the U.S., consumer engagement with advertising has shifted significantly away from traditional channels like TV and radio toward digital platforms. The rise of streaming services, social media, and personalized online content has led to a decline in the influence of traditional advertising methods. And so it should not surprise us that in the United States, at least, pharmaceutical companies are investing heavily in AI-driven targeted advertising.
So pharmaceutical companies are already rethinking their marketing strategies. Many are accelerating a transition away from television and into digital and social media platforms, where advertising regulations are often less stringent and where engagement with consumers can be more personalized.
Platforms such as YouTube, TikTok, and Meta are becoming increasingly attractive alternatives, with some firms leveraging influencer partnerships and unbranded disease awareness campaigns to maintain their presence in the public consciousness. Additionally, companies are bolstering their relationships with healthcare providers, recognizing that physician engagement will become even more critical if DTC advertising is restricted. This has led to renewed investment in in-person sales representation and continuing medical education initiatives designed to ensure that physicians remain well-informed about new treatment options.
As companies explore new strategies for direct patient communication, the role of digital platforms, influencer marketing, and corporate sponsorships has come to the forefront. The 2024 Paris Olympics have provided a powerful case study of how pharmaceutical giants, particularly Sanofi, are leveraging major events to enhance their brand presence while staying within the confines of regional regulatory frameworks (see below). At the same time, the ways that pharmaceutical companies work with patient advocacy groups have come under closer scrutiny and been developed in new ways.
And pharmaceutical companies are increasingly exploring direct-to-consumer sales models that bypass traditional advertising altogether. Platforms such as PfizerForAll and LillyDirect have emerged as key players in the digital health ecosystem, offering telehealth consultations, medication delivery services, and real-time patient engagement tools. These initiatives reflect a broader trend toward integrating digital tools with pharmaceutical marketing to create a seamless and personalized patient experience. The integration of artificial intelligence, personalized medicine, and telehealth services is likely to become a cornerstone of future pharmaceutical marketing and sales strategies.
But advertisers hoping that social and digital environments offer a haven from the regulations besetting TV and radio, should hold off celebrating. The Federal Trade Commission (FTC) as well as the FDA are now closely monitoring social media promotions and influencer-driven campaigns, aiming to curb misleading advertising practices that could distort public perceptions of drug efficacy and safety. Several high-profile cases have brought the use of celebrities and influencers in marketing campaigns into the debate about ethical boundaries in digital marketing.
Across the pond, the European Union maintains a far more restrictive stance on direct pharmaceutical marketing to consumers. Under EU regulations, direct prescription drug advertising is prohibited, and pharmaceutical companies must instead focus on disease awareness campaigns and educational outreach. So, should US advertisers be looking to the EU for inspiration when it comes to crafting messages and engaging audiences in a heavily regulated environment? Certainly, the EU regulatory landscape has forced some creative thinking and led to alternative approaches to patient engagement, including partnerships with healthcare providers, advocacy groups, and digital storytelling initiatives. The use of social media influencers and patient testimonials—while carefully crafted to avoid direct drug promotion—has gained traction as companies attempt to navigate the constraints imposed by EU law.
One of the poster children for this approach is Sanofi. Its involvement in the 2024 Paris Olympics exemplifies a pathway to best practice when it comes to creative strategies within the European regulatory framework. As a premium partner of the games, Sanofi launched "Igniting Potential," a comprehensive corporate campaign designed to position the company as a leader in scientific innovation and inclusivity. This initiative included high-visibility public displays across Parisian metro and train stations, digital activations, and strategic press inserts in Olympic programs and major French media outlets. At Sanofi’s headquarters, an exhibition dedicated to its contributions to immunology and public health underscored the company’s broader commitment to medical progress.
A particularly striking component of Sanofi’s Olympic marketing effort was the Meningitis Flag initiative, in which sponsored athletes affected by the disease, including Paralympians Théo Curin, Davide Morana, and Ellie Challis, were prominently featured. By integrating these athletes into its corporate narrative, Sanofi not only raised awareness of meningitis but also reinforced its role as a company invested in both treatment and advocacy. The visibility afforded by the Olympics allowed Sanofi to engage with a global audience while adhering to the EU’s stringent regulations against direct pharmaceutical promotion.
The interplay between regulatory constraints and marketing innovation highlights broader trends in the future of direct-to-patient engagement. As digital consumption patterns evolve, pharmaceutical companies are shifting away from traditional media and embracing AI-driven content personalization, immersive virtual experiences, and influencer partnerships. The rise of short-form video content (TikTok, Instagram and friends) presents both an opportunity and a regulatory challenge, as companies must balance compelling storytelling with compliance requirements. At the same time, the growing emphasis on patient autonomy and health literacy suggests that educational content will play an increasingly important role in pharmaceutical marketing strategies.
Ethics and Gray Areas : How the Pharmaceutical Industry's Indirect Communication Stragegies with Patient Groups have fared: Recent Examples and Case Studies
As traditional broadcast advertising declines, new approaches are called for to reach patient communities. One of these has long been pharma’s work with patient advocacy groups, and in particular, the provision of funding support which creates opportunities for influence while providing valuable resources to patient communities. But this is not without its critics.
A 2019 study by Johns Hopkins Bloomberg School of Public Health revealed that U.S. patient advocacy groups received a disproportionate share of pharmaceutical industry donations, accounting for 74% of the $120 million given by the world’s ten largest drug companies in 2016. Unlike European nations where disclosure requirements ensured transparency, U.S. financial reporting remained inconsistent, with only six of the ten companies disclosing their contributions. This lack of transparency raised concerns about potential conflicts of interest, given the significant role these groups played in influencing policy, lobbying, and shaping public health decisions.
The study found no clear correlation between a country’s patient advocacy funding and its population size, GDP, or pharmaceutical revenue, suggesting that more than just patient education drove industry contributions. Researchers argued that increased disclosure—whether through voluntary measures or regulatory action—was essential to prevent undue influence. With the U.S. playing a key role in global drug regulation, experts warned that the pharmaceutical industry’s financial support for advocacy groups could have swayed public and legislative opinion in ways that might not always have aligned with patient interests.[1]
Healthcare Professional Influencers
Dr. Austin Chiang, a gastroenterologist with a social media following in the high 500,000s, became Medtronic's first "Chief Medical Officer of Gastrointestinal Health" while maintaining his influencer presence. This represents a growing trend of healthcare professionals with significant social media audiences forming relationships with pharmaceutical and medical device companies.[2]
FDA Warning on Influencer Marketing
In 2019, the FDA sent a warning letter to Diclegis manufacturer Duchesnay after Kim Kardashian promoted the morning sickness drug on Instagram without adequately disclosing risks. This case highlighted regulatory concerns about celebrity and influencer pharmaceutical promotions.[3]
Digital Communities and Support Programs
Pharmaceutical companies develop apps, online communities, and support programs for patients with specific conditions.
Eli Lilly's Diabetes Support Program
Eli Lilly has developed a comprehensive support program for diabetes patients, encompassing educational resources, financial assistance, and digital tools. Their online diabetes patient education resources are designed to assist healthcare professionals in supporting patients and families. Financial assistance is provided through initiatives like the Lilly Diabetes Solution Center, which offers support to individuals struggling to afford their insulin. Additionally, Lilly has ventured into digital health solutions, such as the Lilly Glucagon Mobile App, to aid caregivers and healthcare providers in managing severe hypoglycemia in people with type 1 diabetes. While these programs aim to address patient needs, they may also foster brand loyalty and strengthen connections to Lilly's diabetes products[4]
Novartis' "Living Like You" MS Community
Novartis established an online community for multiple sclerosis patients called "Living Like You." The platform provides support resources while creating awareness in a community that might benefit from Novartis' MS treatments like Gilenya.[5]
Medical Conference Presence
Beyond traditional advertising at medical conferences, pharmaceutical companies engage in alternative approaches to connect with healthcare providers and patients.
Bristol Myers Squibb's Patient Advocacy at ASCO
At the American Society of Clinical Oncology (ASCO) Annual Meeting, Bristol Myers Squibb regularly includes patient advocates in their programming and exhibits. This approach humanizes the company's presence while indirectly highlighting the impacts of their oncology treatments.[6]
Industry-Wide Transparency Initiatives
The pharmaceutical industry association PhRMA established voluntary guidelines for interactions with patient groups, though a study in the New England Journal of Medicine found inconsistent application and disclosure practices across companies.[7]
Conclusion
As the industry moves forward, regulatory developments in both the United States and the European Union will continue to shape the boundaries of permissible marketing practices. The FDA’s anticipated tightening of digital advertising regulations, combined with the EU’s ongoing efforts to refine its stance on patient-directed communication, underscores the complex and evolving nature of pharmaceutical marketing.
Companies that successfully navigate these shifting landscapes—whether leveraging major global events like Sanofi at the Paris Olympics, mastering the use of digital platforms and short form video, and building strategic partnerships with patient groups—will be best positioned to engage with patients once the regulators have had their way. The case of Sanofi at the Paris Olympics in particular, serves as a compelling example of how firms can achieve brand resonance and public engagement while operating within regulatory constraints, marking a potential blueprint for the future of pharmaceutical marketing.