Direct-to-consumer prescription drug sales: Lower prices that may further fragment an already complex system

By Michael Murphy, PharmD, MBA and Jennifer Rodis, PharmD, FAPhA for the PolicyRx newsletter

Americans continue to pay substantially higher prices for prescription medications than patients in other high-income countries. In May 2025, the White House issued an executive order directing the Department of Health and Human Services (HHS) to facilitate direct-to-consumer (DTC) purchasing pathways that would allow patients to buy certain prescription drugs from manufacturers at a “most-favored-nation” (MFN) price. In February 2026, TrumpRx, a website designed to facilitate DTC pricing, launched with 43 medications and is expected to expand.

The intent is straightforward. By allowing manufacturers to sell drugs directly to patients at prices tied to those paid in peer nations, the administration aims to bypass intermediaries and reduce consumer costs. While this approach may lower prices for some medications and some patients, it does not address the underlying structural drivers of high drug costs in the United States. Instead, it risks layering a new distribution model onto an already fragmented health care system without resolving the foundational problems that drive affordability, access and safety concerns.

What is a DTC MFN prescription drug program?

The executive order directs HHS to explore mechanisms that allow manufacturers to offer prescription medications directly to patients at MFN prices. The order does not establish a single operational model, nor does it clearly define how prescribing, dispensing, insurance coverage or patient protections would function in practice. Legal and implementation uncertainty around MFN pricing has also been highlighted in Congressional Research Service analyses.

In reality, DTC prescription drug models rarely eliminate intermediaries. Instead, they typically involve manufacturer-operated digital platforms that coordinate prescribing and fulfillment through affiliated telehealth providers and contracted mail-order or specialty pharmacy facilities. Recent examples include manufacturer platforms such as LillyDirect and PfizerForAll, which emphasize centralized fulfillment and streamlined consumer access.

Importantly, DTC programs are overwhelmingly likely to focus on brand-name medications, particularly single-source drugs without generic or biosimilar competition. These products are the most expensive, most visible to policymakers and most amenable to international price benchmarking.

Federal oversight agencies have also begun issuing guidance on DTC programs. In January 2026, the HHS Office of Inspector General released a special advisory bulletin outlining circumstances under which manufacturer DTC sales to federal health care program enrollees may present a low risk under the federal anti-kickback statute, while cautioning that DTC programs are new, evolving and present fraud, abuse and utilization risks that are not yet fully understood.

Potential impact on patients

Possible benefits 

For some patients, DTC MFN programs could meaningfully reduce out-of-pocket costs, particularly for high-cost, brand-name medications that are poorly covered by insurance or subject to high deductibles and coinsurance. Uninsured or underinsured patients who can afford to pay out of pocket for drugs may see the greatest immediate benefit if DTC pricing undercuts current cash prices.

National estimates suggest that approximately 8% of the U.S. population is uninsured and nearly one in four working-age adults is underinsured, meaning they are insured but face high deductibles or out-of-pocket costs relative to income. However, the subset of these patients who can reliably afford to pay out of pocket for high-cost, brand-name medications remains unknown and is likely limited, given that many uninsured and underinsured individuals already report difficulty affording routine medical care and prescription drugs.

While DTC pricing may offer relief to a narrow group of patients, its broader affordability impact may be constrained by underlying income and cost-sharing barriers. DTC platforms may also reduce administrative friction for certain patients by combining prescribing, payment and fulfillment into a single digital workflow.

Risks and unintended consequences

Prescriptions are still required
Despite the “direct” framing, patients will still need a prescription from a licensed prescriber. This means scheduling a clinical encounter, navigating documentation requirements and transmitting a prescription to the manufacturer or its fulfillment partner.

To streamline this process, manufacturers are incentivized to embed telehealth prescribing into their DTC platforms. While this may increase convenience, it also introduces new pressures on prescribers to accommodate patient requests for specific brand-name therapies. Research has shown that direct-to-consumer promotion and consumer-driven requests are associated with higher prescribing rates, including cases of inappropriate prescribing.

Fragmentation of medication records
DTC programs are likely to rely on centralized mail-order pharmacies selected by manufacturers to minimize dispensing costs. As a result, patients may end up filling brand-name medications through a DTC mail-order channel while continuing to obtain most of their other medications—primarily generics—from local community pharmacies.

Because there is no universal health record and pharmacy systems do not reliably communicate across unaffiliated organizations, pharmacists may lack a complete picture of a patient’s medication regimen. Studies have shown that using multiple pharmacies is associated with lower adherence and increased risk of medication-related problems. Ongoing federal efforts to address health information blocking highlight how persistent interoperability barriers remain.

This fragmentation also affects medical documentation. Medications obtained through DTC programs may not reliably appear in prescribers’ electronic health records, particularly when prescriptions and dispensing occur outside of affiliated health systems or insurance claims workflows. Incomplete medication lists can undermine medication reconciliation, increase the risk of duplicative or conflicting therapy, and create blind spots during care transitions, even as federal efforts to improve interoperability continue to fall short of comprehensive, real-time data sharing.

Insurance coverage ambiguity
It remains unclear whether DTC MFN drugs will be integrated into existing insurance benefits or offered primarily on a cash-pay basis. If patients pay out of pocket, those costs may not count toward deductibles or out-of-pocket maximums, creating inequities and uncertainty in long-term affordability. Recent federal guidance reinforces this concern, noting that when DTC medications are purchased outside of insurance benefits, those costs do not count toward Medicare Part D true out-of-pocket spending or other program thresholds, further complicating affordability, care management and continuity of treatment.

This ambiguity also affects medical care, as medications obtained outside of insurance benefit structures may not reliably appear in prescribers’ records or claims-based care management systems, limiting clinicians’ ability to monitor adherence, manage therapy and assess cost-related barriers over time. This dynamic may also bias claims-based research and policy evaluation, as medications obtained outside of insurance benefit structures would not be captured in administrative datasets commonly used to assess medication use, adherence, outcomes or program effectiveness.

Potential impact on pharmacists and pharmacies

Risks and unintended consequences

Reduced exposure to underpaid brand dispensing
Brand-name medications are frequently reimbursed below acquisition cost in traditional pharmacy benefit designs. As a result, pharmacies may not view reduced brand dispensing volume as inherently negative. Limiting exposure to consistently underpaid brand-name drugs could reduce financial losses for some community pharmacies.

Increased care fragmentation and uncompensated workload
Shifting brand-name medications to DTC channels while generics remain in community pharmacies creates operational and clinical challenges. Pharmacists may still be asked to reconcile medication lists, counsel patients on therapies they did not dispense and address adverse effects or adherence issues related to DTC medications, often without access to complete information.

This dynamic also weakens established local pharmacist–prescriber relationships, reducing opportunities for timely, informal communication that supports medication optimization, shared decision-making and early intervention when patients experience side effects or adherence challenges.

Long-term implications for pharmacy access
If DTC models grow without guardrails, they could accelerate reliance on centralized mail-order dispensing at the expense of local pharmacy access. This is particularly concerning in rural and underserved communities, where pharmacy closures have already contributed to reduced access to care.

Policy considerations to improve DTC MFN programs

1. Require patient choice in dispensing location

Allow patients to receive DTC-priced medications through the pharmacy of their choice, including local community pharmacies, rather than defaulting to manufacturer-selected mail-order facilities.

Pros

• Reduces fragmentation by keeping medications within a single pharmacy record when possible
• Preserves patient choice and local access
• Supports continuity of care and medication safety

Cons

• Requires viable mechanisms for pharmacies to acquire brand-name drugs at sustainable prices and would need to be associated with fair and appropriate dispensing reimbursement.
• May increase overall program costs compared to centralized mail-order fulfillment

2. Integrate DTC medications into insurance benefits by default

Structure DTC MFN programs so medications are processed through existing insurance coverage whenever possible, with transparent cash-pay options as a secondary pathway.

Pros

• Ensures patient costs count toward deductibles and out-of-pocket maximums
• Reduces inequities between patients who can and cannot afford upfront cash payments
• Improves continuity of coverage and adherence

Cons

• Reintroduces payer complexity and administrative requirements
• Limits the perceived simplicity of “cutting out the middleman”

3. Establish guardrails for telehealth prescribing within DTC platforms

Implement clear standards to separate marketing from clinical decision-making in manufacturer-affiliated telehealth arrangements.

Pros

• Addresses well-documented risks that consumer-driven medication requests and platform-based prescribing models can influence prescribing patterns, particularly when access pathways are aligned with specific products or fulfillment channels
• Protects patients from low-quality, high-volume prescribing models
• Reinforces clinical appropriateness over consumer demand

Cons

• Enforcement and oversight are challenging
• May reduce convenience, a key selling point of DTC models

4. Require interoperability and medication record sharing

Require DTC fulfillment pharmacies to share standardized medication information with a patient’s chosen pharmacy and prescriber.

Pros

• Improves medication safety and reduces adverse events
• Mitigates risks associated with split dispensing across multiple pharmacies

Cons

• Technical and contractual barriers remain significant
• Raises data governance and privacy considerations

5. Explore a bifurcated model: DTC for brand-name drugs, community pharmacy for generics

Intentionally shift most brand-name medications to DTC mail-order distribution while preserving community pharmacy dispensing for the majority of medications, which are generics.

Pros

• Reduces pharmacy exposure to consistently underpaid brand-name drugs
• Allows community pharmacies to focus on generic dispensing, where margins are more sustainable
• Could stabilize pharmacy business models if implemented carefully

Cons

• Significantly increases care fragmentation without strong interoperability requirements
• Risks normalizing split medication records and reduced pharmacist oversight
• May entrench mail-order dependency and weaken local access over time
• Could create patient access challenges for acute or emergency brand name medications

The bottom line

DTC MFN prescription drug programs are well-intentioned attempts to relieve pressure on patients facing high drug costs. However, they represent another example of a narrow intervention applied to a deeply flawed and fragmented health care system.

Lower prices for some medications may come at the cost of increased division of care, distorted prescribing incentives and new safety risks for patients. Any DTC approach should be evaluated not only on price but also on its impact on access, care and health care professional coordination, and the long-term sustainability of the medication-use system.