With increased uncertainty over the future of the traditional pharmacy benefit manager (PBM) paradigm, along with direct pressures from multiple President Administrations over drug prices, the pharmaceutical industry has seen a marked increase in the development and adoption of so-called direct-to-consumer (DTC) distribution and engagement models. Once concentrated primarily in wellness and lifestyle categories, DTC channels are now expanding into specialty therapeutics, chronic disease management, and even high-touch clinical categories traditionally dominated by conventional provider-driven prescribing. From Eli Lilly’s LillyDirect for GLP-1 drugs, to Sanofi’s direct sales of Plavix through TrumpRx, pharmaceutical manufacturers, pharmacies, technology companies, and even the federal government are each playing a role in shaping what is now a diverse and rapidly evolving DTC ecosystem.
The Business Case for DTC Pharmacy Models
As manufacturers explore new ways to reach patients, improve adherence, and differentiate their brands, and as pharmacies seek innovative pathways to drive prescription volume, stabilize revenue streams, and secure manufacturer relationships, the DTC model has emerged as both a compelling commercial opportunity and a regulatory minefield. The result is an industry moment marked by aggressive innovation coupled with heightened legal scrutiny.
The New Wave of DTC Pharmacy Models
Recent years have produced a broad range of DTC structures, spanning both branded and unbranded pathways. These models have been both manufacturer and pharmacy-driven, and incorporate a range of different components.
- Branded manufacturer-driven DTC programs. Major manufacturers have begun offering branded online portals or digital funnels that engage patients directly, often combining disease education, telemedicine provider networks, and fulfillment pharmacy partnerships. These models frequently integrate benefits investigations, copay support, and refill workflows to streamline the patient’s path to therapy.
- Platform-based DTC models for high-demand categories. Weight-management, dermatology, sexual health, and mental health therapies – particularly those involving GLP-1 products, hormonal therapies, or lifestyle medications – have fueled a surge in consumer-facing platforms offering virtual consultations paired with pharmacy fulfillment.
- Hybrid DTC provider models. Some companies have adopted approaches that blend traditional prescriber engagement with DTC elements, such as digital screening tools, automated patient onboarding, direct manufacturer-to-patient education, and specialty pharmacy coordination that reduces friction for both prescribers and patients.
- Pharmacy-anchored DTC models. Many pharmacies, especially specialty and compounding pharmacies, have built their own DTC platforms or partnered with consumer-facing brands seeking vertically integrated fulfillment. These arrangements vary from white-label fulfillment relationships to more complex data-sharing and revenue-aligned structures.
These models differ significantly in their operational design, but all share a common thread: a shift toward direct engagement with the patient, with pharmacies and manufacturers increasingly interconnected through digital workflows and coordinated marketing.
Market Forces Driving the Growth of DTC
Several converging political, economic, and cultural factors have accelerated the turn toward DTC models. Perhaps most importantly, in the wake of the COVID-19 pandemic, consumer expectations have shifted. Patients, now accustomed to streamlined digital experiences in retail, banking, and telehealth, expect similar convenience in accessing medications. This has not only changed the face of what it means to be “retail” in the pharmacy space, but it has also created a clear marketplace for pharmaceutical manufacturers to deliver their products.
Almost as critical to the rise in DTC models is the increase in payor restrictions (such as prior authorizations and step therapies) and the economics of rebate driven PBM plans, which have driven manufacturers to find alternative distribution channels. Patients are becoming savvier and more aware of the role PBMs have played in increasing drug prices through rebates, and with the expansion of high-deductible plans and inconsistent benefit designs, many patients have become more willing to seek cash-pay alternatives. Manufacturers have realized this phenomenon and have sought to go around the hurdles and restrictions associated with PBMs, while realizing roughly the same net profit when selling directly to patients.
Finally, there has been a rise in political and social pressure on the traditional PBM construct, which has simultaneously advanced DTC concepts. Congressional hearings, state-level PBM reforms, and broad public skepticism of the traditional drug-pricing system have made room for innovative distribution channels that reduce perceived intermediaries. At the same time, market entrants, like Mark Cuban Cost Plus Drug Company, have demonstrated that patients can achieve real savings when obtaining medications through DTC pathways. The Trump Administration has realized this, too, and in late-2025, the Administration launched TrumpRx, a platform aimed at facilitating direct pricing between manufacturers and patients, completely outside the scope of PBMs.
Common Attributes of Modern DTC Models
Despite variations in design, successful DTC programs generally share several structural elements:
- Patient acquisition funnels. These include digital marketing, education tools, symptom-checkers, and brand-specific landing pages, which serve as the “front door” to the patient journey.
- Integrated telemedicine networks. Most programs include contracted physician groups or telemedicine providers who evaluate the patient and issue prescriptions where clinically appropriate. These relationships raise significant compliance considerations around fee-splitting, Corporate Practice of Medicine (CPOM), and inducement concerns.
- Designated or preferred fulfillment pharmacies. Pharmacies play a central role in tying the patient journey together by managing dispensing, patient communications, refills, Risk Evaluation and Mitigation Strategy requirements (as applicable), and sometimes clinical monitoring. Their relationships with manufacturers must be structured carefully to avoid anti-kickback statute and state-law fee-splitting risks.
- Data and analytics frameworks. Manufacturers often expect robust reporting on adherence, utilization, and clinical outcomes. Sometimes these arrangements may even seek data on competitor utilization. Data-sharing agreements must be crafted to comply with HIPAA, consumer privacy laws, and commercial contract restrictions.
- Financial support and pricing structures. Cash-pay pricing, manufacturer-subsidized programs, and copay assistance may intersect with federal and state fraud-and-abuse rules, particularly where Medicare or Medicaid beneficiaries are involved.
- White-label and co-branded patient experiences. Branding arrangements, whether the pharmacy is behind the scenes or consumer-facing, must comply with state pharmacy advertising regulations and avoid misrepresentations to consumers and payors.
Conclusion
DTC pharmacy models present a transformative opportunity for manufacturers and pharmacies seeking to modernize the patient experience, improve adherence, and differentiate their brands. Yet, these models operate in one of the most heavily regulated sectors of the healthcare economy.
How Frier Levitt Can Help
Manufacturers, pharmacies, and emerging DTC platforms should engage experienced healthcare counsel early in the process to ensure their models are compliant, scalable, and defensible. Frier Levitt has extensive experience advising pharmaceutical companies, technology platforms, telemedicine providers, specialty pharmacies, and other innovators on structuring DTC pathways that balance commercial objectives with rigorous legal compliance.
If your organization is exploring a DTC launch, restructuring an existing program, or evaluating partnerships with pharmacies or telemedicine providers, our team can help you navigate these issues and design a compliant pathway forward.
Read Part 2 of the series on DTC Models: Legal, Regulatory, and Compliance Considerations for Direct-to-Consumer Pharmacy Models
