The Critical Layer for Pharma's Growing Direct-to-Patient Play

Direct-to-patient (DTP) programs are proliferating. Since the US government mandate urging major drugmakers to provide DTP commitments, 17 companies have signed agreements to launch these programs, and analysts project the US DTP market will continue growing 12% annually through 2033.^1,2

However, given how new DTP programs are, there are no tried-and-true commercialization strategies to rely on, and existing laws, such as the Anti-Kickback Statute, have yet to be directly applied to DTP programs by courts. In January of this year, HHS' Office of Inspector General issued direct guidance on how the Anti-Kickback Statute applies to DTP programs, but the guidance did not address key relationships in the ecosystem, including those between manufacturers and prescribers, pharmacies, and telehealth platforms.³ The guidance itself acknowledged this gap, and Senators Dick Durbin (D-IL), Elizabeth Warren (D-MA), and Peter Welch (D-VT) quickly followed up with a letter raising concerns that prescriptions written through DTP telehealth do not always stem from legitimate medical encounters.⁴

To date, regulators have not issued clear, comprehensive guidance to help drug manufacturers navigate DTP. This leaves manufacturers, pharmacies, DTP platform providers, and others to piece together a patchwork of disjointed, sometimes misaligned, regulations and guidance that continues to evolve in real time. This unsettled landscape creates a challenge for DTP commercialization strategies. Manufacturers must design programs that meet patient expectations, run efficiently, and comply with the law, all while remaining nimble enough to adjust as requirements change. Manufacturers that cannot adapt quickly face the greatest risk of falling behind on compliance, facing legal consequences, or failing to serve the patients these programs are meant to help.

A compliance-first DTP program is the engine behind better access, affordability, and adherence outcomes. Manufacturers that have or are considering a DTP program today are effectively choosing between two paths: building to the current compliance standard and adjusting reactively as guidelines change, or designing a program dynamic and flexible enough to let the infrastructure evolve in real-time. The first path means playing catch-up indefinitely. The second is the compliance-by-design framework for manufacturers that want to lead the DTP era, setting the new standard for patient experience and commercial success.

Navigating DTP Priorities

Manufacturers building DTP programs balance several considerations at once: how to build the best possible experience for patients, how to support the brand’s commercial performance, and how to hold up against every applicable regime, including federal, state, pharmacy, and payer requirements.

Patients want transparent pricing and an intuitive, easy-to-use experience.⁵ Manufacturers want a program that balances brand performance with the flexibility to evolve as patient needs and regulations change. When DTP programs are built on siloed, inflexible systems, manufacturers often have to make significant trade-offs among these priorities, sometimes overhauling entire programs to satisfy new guidelines or sacrificing efficiency and program success along the way.

Compliance-by-design programs address these key considerations in tandem. They dynamically route each patient to the most affordable access pathway, available through an easy-to-use experience, and apply a hybrid approach with custom business rules that protect commercial performance, continuously monitoring the regulatory landscape so the infrastructure can adapt to shifting requirements.⁶ This design translates into measurable improvements in access, affordability, and adherence.

What Are the Key Compliance Considerations Shaping the Current Landscape?

The current compliance landscape presents several important considerations for manufacturers building and expanding DTP programs:

• Increased risk exposure the closer a program sits to the patient. For manufacturers running branded DTP programs, the line between prescriber, pharmacy, and manufacturer is blurred, meaning every touchpoint, welcome calls, educational content, telehealth partnerships, carries more regulatory weight than the equivalent moment in a traditional model.
• Wider legal surface area for coverage programs. Historically, DTP programs have been cash-pay models. When a DTP strategy includes insurance-covered prescriptions, laws such as the federal Anti-Kickback Statute and state kickback laws are squarely implicated. In addition to complying with these laws, the pharmacy network facilitating the dispenses must remain compliant with its payer contracts.
• Enhanced scrutiny over telehealth encounters. Adding a telehealth prescribing component to a commercialization strategy raises legal considerations that a traditional model does not.⁷ Corporate practice-of-medicine doctrine and telehealth rules vary by state, and each encounter must comply with multiple applicable laws, requiring rigorous structuring upfront and ongoing monitoring.
• Increased guardrails for data sharing and management. DTP programs offer an unprecedented ability to obtain patient authorization for data collection and to share data across multiple vendors, capturing engagement points from advertising through dispensation to build more personalized patient experiences. This consolidated data is a strong advantage for visibility and customization, but it requires an intricate architecture to maintain data privacy and integrity.
• Ongoing monitoring of new guidelines. Changes at the federal, state, pharmacy, and PBM levels must be continuously monitored to flag new or conflicting guidance, ensuring DTP programs remain compliant across jurisdictions.

Each of these compliance considerations is a moving target, which is exactly why the underlying infrastructure must be able to adjust dynamically as the landscape evolves.

Compliance-By-Design: Building Infrastructure that Evolves

Static, siloed DTP infrastructure defaults to the worst-case common denominator: applying the most restrictive compliance rules to all patients, regardless of where they live or how they prefer to access their medications. Building one blanket requirement is simpler than building a system that adjusts to each patient, brand, and jurisdiction. These systems often apply the same rigid requirements to every patient regardless of actual risk, creating delays unrelated to real regulatory risk and leaving manufacturers with little visibility into how the prescription access journey could be improved. A rigid system that cannot absorb the next compliance shift not only creates legal exposure but also degrades the patient experience the program exists to deliver.

The alternative is to treat compliance as a systems-architecture discipline. compliance-by-design infrastructure treats regulatory rules as structured program requirements. The system is measurable and flexible by design. Each interaction can be evaluated at the federal, state, payer, or program level and evolves systematically to meet the corresponding guidance. Continuous feedback loops monitor for and apply new compliance guidance across these levels in real time. Compliance-driven artificial intelligence (AI) takes this operational infrastructure to the next level, scaling each manufacturer’s ability to balance speed to therapy with compliance. For example, according to a 2026 script audit from PHIL, AI-driven script audits route 100% of scripts in real time for the most appropriate path to therapy for each patient.⁸ This ensures a government beneficiary who received a cash-pay dispense earlier in the year does not later revert to a covered claim in the same calendar year.

The impact shows up across every program priority. Patients get routed to the most cost-effective access pathway available, with an easy-to-use experience and clear visibility into where their prescription stands at each step. Brand performance holds steady because the program never has to be rebuilt piecemeal or overhauled to stay compliant with changing rules. Compliance stops being a periodic scramble to reconstruct what happened: the same infrastructure ensures the flexibility to comply with every applicable regime across each governing domain.

The new standard for evaluating DTP infrastructure is not simply whether it satisfies today's compliance requirements, but whether it can continue to evolve with them.

Wait and Follow, or Build to Lead

Where DTP compliance will land is unknown, and the landscape will continue to evolve. That uncertainty is the argument for acting now, not a reason to wait. Manufacturers who wait will spend the next several years reacting to the next letter, the next bulletin and the next state rule. They will remain a step behind those that have built dynamic systems with the flexibility to move first. Manufacturers who put the right systems in place today, built to keep pace with the evolving landscape, will be best positioned to lead pharma’s DTP play, turning strategic program design into the new standard for access, affordability, and adherence.

Chander Viswanathan is chief technology, product and operations officer at PHIL Inc. Shannon Wiley, JD is a member at Bass, Berry and Sims.

References

1. Reuters. Global pharma companies that have publicly announced Trump drug pricing deals. Reuters. Published May 4, 2026. Accessed August 10, 2026. https://www.reuters.com/business/healthcare-pharmaceuticals/global-pharma-companies-that-have-publicly-announced-trump-drug-pricing-2026-05-04/
2. Coherent Market Insights. U.S. Direct to Patient Market Share & Analysis 2026-2033. Coherent Market Insights. Published April 9, 2026. Accessed August 10, 2026. https://www.coherentmarketinsights.com/industry-reports/us-direct-to-patient-market
3. U.S. Department of Health and Human Services, Office of Inspector General. Special Advisory Bulletin: Application of the Federal Anti-Kickback Statute to Direct-to-Consumer Prescription Drug Sales by Manufacturers to Patients With Federal Health Care Program Coverage. HHS OIG. Issued January 27, 2026. Accessed August 10, 2026. https://oig.hhs.gov/documents/special-advisory-bulletins/11450/OIG--FINAL--Special-Advisory-Bulletin.pdf
4. Durbin RJ, Warren E, Welch P. Letter to T. March Bell, Inspector General, U.S. Department of Health and Human Services Office of Inspector General. January 29, 2026. Accessed August 10, 2026. https://www.durbin.senate.gov/imo/media/doc/durbin_hhs_oig_letter_on_trumprx.pdf
5. PHIL Inc. DTP Research. PHIL. Accessed August 10, 2026. https://phil.us/dtp-research/
6. Bridges A, Eckert C. Beyond DTP 2.0: How Flexible Direct-to-Patient Programs Power Best-In-Class Patient Experiences. Drug Channels. Published February 27, 2026. Accessed August 10, 2026. https://www.drugchannels.net/2026/02/beyond-dtp-20-how-flexible-direct-to.html
7. U.S. Food and Drug Administration. FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s. FDA News Release. Published March 3, 2026. Accessed August 10, 2026. https://www.fda.gov/news-events/press-announcements/fda-warns-30-telehealth-companies-against-illegal-marketing-compounded-glp-1s
8. PHIL Inc. Internal data. 2026. Unpublished.

Disclaimer: This article is for general informational purposes and does not constitute legal advice.