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Direct-to-Patient Pharma Models: A Strategic and Regulatory Appraisal of Risks, Opportunities, and the Critical Role of Medical Affairs

  • Dillon Shokar
  • Oct 3
  • 8 min read

Abstract

Direct-to-patient (DTP) pharmaceutical distribution models, which integrate telehealth consultations, digital prescribing, and direct medication delivery, are rapidly expanding in the United States. High-profile initiatives such as Eli Lilly’s LillyDirect, Pfizer’s emerging digital channels, and consumer brands like Hims & Hers highlight both the disruptive potential and the regulatory fragility of this approach. While these models promise improved access, adherence, and patient convenience, they raise significant concerns around affordability, care fragmentation, medicalization, and regulatory compliance. Using a PESTLE framework (Political, Economic, Social, Technological, Legal, Ethical), I critically appraise DTP distribution models through academic literature, policy guidance, and case examples. I also distinguish them from direct-to-consumer (DTC) advertising, which faces intensifying regulatory curtailment and political attack. My central argument is that DTP distribution models can only be sustainable if governed by Medical Affairs, which provides the necessary guardrails of scientific integrity, evidence generation, and patient trust. For pharmaceutical executives, the strategic imperative is clear: assess DTP readiness systematically, invest in Medical Affairs-led governance, and design evidence-driven pilot programs. Without these foundations, DTP risks not only commercial underperformance but also reputational and regulatory failure.


Introduction

The pharmaceutical industry is undergoing a structural shift in how patients access medicines. Historically dependent on physician visits, retail pharmacies, and PBM-driven formularies, the pathway from prescription to treatment is increasingly mediated by digital channels. In January 2024, Eli Lilly launched LillyDirect, a direct-to-patient (DTP) distribution model offering telehealth consultations and integrated pharmacy fulfillment for obesity drugs (Rome, 2024). Pfizer has also piloted consumer-facing digital channels for chronic therapies (Biopharma Dive, 2024). In parallel, consumer health brands such as Hims & Hers and Ro have scaled comparable distribution models across sexual health, dermatology, and mental health (Ventola, 2011; Fain, 2014). It is essential, however, to distinguish DTP distribution models from direct-to-consumer (DTC) advertising. The former is rising, driven by telemedicine adoption, digital pharmacies, and patient demand for convenience. The latter is under mounting scrutiny. The FDA has begun classifying telehealth and influencer-driven promotion as DTC advertising, subjecting them to the same risk-disclosure requirements as television or print campaigns (FDA, 2025; HHS, 2025). Political voices such as Robert Kennedy Jr. have sharpened the critique, framing DTC advertising of GLP-1s and psychiatric drugs as emblematic of over-medicalization (Pew Research, 2023). My argument is that DTP distribution models cannot be insulated from this regulatory climate. Their promotional aspects blur into advertising, and without governance by Medical Affairs, the very features that make DTP attractive, such as convenience, direct engagement, and patient empowerment, may become liabilities. I therefore use a PESTLE framework to appraise the risks and opportunities of DTP distribution models and argue that Medical Affairs must lead their design, oversight, and evidence generation.


Analytical Framework: A PESTLE Appraisal of DTP Distribution Models

  1. Political: DTP distribution models operate in a volatile political environment. Both Republican and Democratic administrations have prioritized lowering prescription drug costs (Kesselheim et al., 2022). Populist critiques of “Big Pharma” have amplified narratives around over-medicalization, especially in obesity and mental health (Pew Research, 2023). I view this as creating a reputational tightrope: policymakers see direct engagement with patients by manufacturers as potentially inflationary rather than cost-saving. Any perception that DTP bypasses PBMs or erodes rebates risks triggering further legislative scrutiny.

  2. Economic: Evidence suggests DTP distribution does not uniformly lower patient costs. Anderson et al. (2024) found only 9 of 33 generics (27 percent) offered through a DTP pharmacy were cheaper at the patient level compared to commercial insurance, though 29 (88 percent) were cheaper in terms of total system cost. This bifurcation complicates payer alignment: aggregate efficiency gains do not always translate into individual affordability. Moreover, rebate structures mean bypassing PBMs risks raising premiums. Manufacturers may capture short-term margin through refill capture and abandonment reduction (IQVIA, 2023), but the sustainability of those economics depends on payer acceptance, which will be influenced by how closely distribution models are perceived to resemble curtailed DTC advertising.

  3. Social: DTP distribution models are most visible in therapy areas where stigma and access barriers are high, such as obesity, sexual health, dermatology, and mental health (Patel et al., 2021). Evidence suggests telemedicine improves initiation and continuity of care in these domains (Goldstein et al., 2022). Yet patient trust in pharma remains fragile, with fewer than 40 percent of Americans expressing confidence in pharmaceutical companies (Edelman, 2024). If DTP distribution is seen as advertising in disguise, it risks reinforcing distrust rather than reducing stigma.

  4. Technological: The technological backbone of DTP distribution includes telehealth platforms, automated benefit verification, and integrated logistics (Greenhalgh et al., 2018). These same tools, however, are often embedded in marketing interfaces such as websites with patient journeys, apps with push notifications, or chatbots that double as product selectors. As regulators increasingly treat these as promotional, the technological overlap between distribution and advertising exposes companies to compliance risks unless Medical Affairs sets the boundaries.

  5. Legal: The FDA’s 2025 warning to Hims & Hers for misbranding compounded semaglutide illustrates the legal fragility of models that conflate distribution with promotion (FDA, 2025). The company’s high-profile Super Bowl ad, criticized for omitting risk disclosures (Reuters, 2025), blurred the line between DTP distribution and DTC advertising. More broadly, HHS now requires digital, telehealth, and influencer-based touchpoints to be treated as advertising (HHS, 2025). Legally, this means every patient-facing asset in a DTP distribution model can be classified as promotional labeling unless governed with rigorous oversight.

  6. Ethical: The ethical critique of DTP distribution is inseparable from the critique of DTC advertising. Both risk incentivizing demand for drugs beyond clinically appropriate populations. Kennedy Jr. and others argue that pharma channels fuel over-medicalization (Pew Research, 2023). At the same time, telehealth distribution can expand access for underserved groups, particularly in rural areas (Patel et al., 2021). I believe that the ethical sustainability of DTP hinges on Medical Affairs-led stewardship, which defines eligibility, embeds deprescribing pathways, and ensures that distribution expands appropriate access without amplifying unnecessary consumption.


Case Studies and Evidence Review

LillyDirect represents the archetype of a DTP distribution model with manufacturer ownership. Early reports suggest uptake has been significant in obesity treatment, but payer acceptance remains uncertain (Rome, 2024). By contrast, Amazon’s PillPack and Mark Cuban’s Cost Plus Drugs demonstrate that technology-driven pharmacy models can deliver system-level cost savings, but their integration with manufacturers is limited (IQVIA, 2023). The clearest warning comes from Hims & Hers. While its DTP distribution has scaled rapidly in sexual health and weight loss, its reliance on consumer advertising has triggered regulatory sanction. In 2025, the FDA issued a misbranding warning for its compounded GLP-1 products (FDA, 2025), and its Super Bowl ad was censured for lack of balanced risk communication (Reuters, 2025). This illustrates the strategic danger: when DTP distribution overlaps too closely with DTC advertising, the model becomes politically and legally vulnerable.


Why Medical Affairs Must Lead

Recent regulatory developments underscore that every digital patient-facing interaction may be classified as advertising. In 2025, the FDA issued guidance equating digital, influencer, and telehealth promotion with traditional DTC channels (HHS, 2025; Latham & Watkins, 2025). In practice, this means that distribution platforms, even when primarily transactional, fall within the remit of promotional regulation. Marketing teams cannot alone shoulder this burden. Only Medical Affairs has the mandate and credibility to ensure that DTP distribution becomes a channel for evidence-based care rather than an extension of advertising. In my view, Medical Affairs must lead in three domains. First, governance: ownership of patient-facing content, AE monitoring, and escalation pathways. Second, evidence: real-world evidence generation that links DTP with adherence, outcomes, and cost offsets, capable of satisfying both payers and regulators. Third, stewardship: integration of DTP with the broader continuum of care, including data flows to primary care and deprescribing frameworks in high-risk areas such as GLP-1s.


Strategic Implications for Pharma

The implications are clear. DTP distribution models are strategically viable only when Medical Affairs leads governance. For executives, I recommend three immediate steps. First, conduct a DTP readiness audit, mapping therapy areas against patient need, payer acceptance, and regulatory risk. Second, establish a Medical Affairs governance board with veto rights over digital touchpoints, chatbot scripts, and promotional assets. Third, launch pilot programs tied to formal RWE studies, publishing outcomes to demonstrate stewardship and transparency. These steps not only safeguard compliance but also build trust with payers, regulators, and patients.


The Human Dimension

Patients are not abstractions in a distribution channel. They are individuals navigating illness, stigma, and uncertainty. A woman considering a GLP-1 is weighing affordability, social judgment, and health risks. A man using a digital app for migraine therapy seeks relief without an ER visit, not an algorithmic sales journey. If DTP distribution models are reduced to transaction channels, they will fail. If they are governed by Medical Affairs with patient trust at the center, they can succeed.


Final Thoughts

DTP distribution models are rising, while DTC advertising is facing regulatory curtailment and political attack. The overlap between the two creates strategic risk, since distribution platforms rely on promotional infrastructures that are under scrutiny. My conclusion is unambiguous: without Medical Affairs leadership, DTP distribution will not be sustainable. With Medical Affairs leadership, however, these models can become credible patient-first capabilities that improve access, demonstrate outcomes, and create value for all stakeholders. For executives considering whether to launch or scale DTP distribution, the next step must be a structured strategic assessment. At Princeton Biopartners, my colleagues and I have advised Fortune 500 pharma and emerging biotech firms on Medical Affairs strategy, payer engagement, and evidence generation. If your organisation is evaluating DTP distribution, I invite you to connect with me to design an evidence-based roadmap that ensures your model is compliant, sustainable, and trusted.


Figure: Cost reduction in direct-to-consumer pharmacy vs commercial insurance for generics (Anderson et al., 2024).


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Sources

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