How PDURS may reshape therapeutic value, and what it demands of organisations prepared to act.
For most of the past decade, the convergence of digital technologies and therapeutics has represented an evolving ambition rather than a fully defined model. Much of pharma’s software innovation has orbited around the drug, positioned as a companion, an adherence aid, or a support layer—highly valuable, but rarely integral to the therapy itself. Digital therapeutics (DTx) pushed further, establishing the credibility of software as a clinical intervention. Yet regulatory frameworks continued to treat digital and drug as distinct categories, and commercial models reinforced that divide. Payers lacked clear reimbursement mechanisms. Physicians had limited prescribing pathways. And DTx pioneers, despite strong clinical ambition, often operated outside established reimbursement channels and clinical workflows.
Prescription Drug Use-Related Software (PDURS) changes the geometry of that problem. The FDA’s draft guidance, published in September 2023, does not simply regulate software that sits alongside drugs. For the first time, it creates a formal mechanism through which software may be embedded within a drug’s label, provided it can demonstrate meaningful clinical benefit. More than just a refinement, this represents a structural shift in how therapeutic value can be defined, evidenced, and communicated.
From Peripheral to Component
To understand what makes PDURS significant, it is helpful to consider what came before it. The first-generation DTx movement generated genuine scientific progress and genuine commercial frustration. Prescription digital therapeutics demonstrated that software could be regulated, produce clinical outcomes, and earn FDA clearance. But independent commercialisation proved difficult: without an anchor to an existing drug, DTx had to carve out their own reimbursement codes, their own place in clinical workflows, and brand recognition in a system not designed to receive them
PDURS does not resolve all of those challenges, but it reframes the starting position entirely. Rather than asking payers to reimburse software as a standalone product, it allows sponsors to present software as an integral part of a therapy they already cover. Rather than asking physicians to prescribe a digital treatment they may not fully understand, it positions software as an extension of a drug they already prescribe. The regulatory pathway is new, but the commercial scaffolding already exists.
The Label as a Strategic Asset
That scaffolding, however, is only the entry point. If PDURS reaches its potential, the drug label, long a document of compliance, becomes a vehicle for competitive differentiation. Validated, evidence-based software-driven claims become part of the therapeutic offering, extending treatment beyond pharmacology to shape how patients engage with, adhere to, and experience care. Over time, the data generated could enable more optimised or personalised dosing, improved side-effect management, and outcomes that pharmacology alone cannot deliver.
The implications cascade across commercial strategy – and across organisational structure. For brand teams, a PDURS-enabled label represents a meaningful lever for lifecycle management, expanding the value proposition of an existing product without requiring a new molecular entity. Realising that potential, however, extends beyond the remit of commercial teams alone. Software-enabled therapeutics sit at the intersection of R&D, regulatory, clinical, medical affairs, and commercial functions, and traditional vertical structures are not well configured to deliver them. Evidence generation, regulatory engagement, scientific communication, and commercial positioning must move in concert, not in sequence.
Pfizer’s decision to establish a PDURS Centre of Excellence – and appointing Marty Culjat as Digital Medicine & PDURS Strategy Lead to drive drug-digital integration across the portfolio by aligning regulatory, clinical, commercial, and policy perspectives – signals that this is being treated as an enterprise-wide capability with pipeline relevance across therapeutic areas. Pfizer’s previous commentary to CMS has pointed specifically to oncology and cardiometabolic conditions as priority domains for digital medicine, areas where behavioural factors heavily influence outcomes and where software-driven adherence, monitoring, and engagement can translate into meaningful clinical gains. When a company of that scale builds infrastructure aligned with a regulatory framework and signals priority therapeutic areas, it reflects a long-term investment thesis.
For payers, software formally acknowledged within an FDA-approved label enters familiar evidential territory, considerably easier to accommodate within existing coverage frameworks than a standalone digital product seeking its own pathway from scratch.
But the label is only part of the story.
What the Label Cannot Do
PDURS governs what a drug sponsor can claim about its own software, creating an evidential and regulatory framework for that relationship. What it cannot do is govern adoption. And adoption, as the DTx movement demonstrated, does not follow automatically from regulatory success.
The most meaningful drivers of adoption – physician trust, peer influence, workflow fit, and patient confidence – extend beyond the label. PDURS can inform a prescriber that a specific software component has produced a clinically meaningful improvement in a particular outcome. Ensuring that the prescriber (and patient) believes it, integrates it, and recommends it is a different challenge entirely. The organisations that will gain the most from PDURS are those that build both layers in parallel: the regulated evidence framework that proves efficacy, and the engagement infrastructure that makes those interventions usable, trusted, and scalable in real clinical practice. In that sense, PDURS creates not one competitive frontier, but two, and credibility in both will determine who captures the opportunity it creates.
The Moment Before the Map Is Drawn: Where PDURS Stands
As of March 2026, the guidance remains in draft form, with no finalised policy and no definitive timeline. Industry stakeholders, ranging from PhRMA and the Digital Therapeutics Alliance to Eli Lilly and Teva, have called for greater clarity, with key questions remaining on evidence standards, PDURS’ relationship to Software as a Medical Device (SaMD), and the boundary between promotional and clinically required outputs. Among the most consequential: the role of AI. As software embedded in drug programmes becomes more adaptive and algorithmically complex, the American Telemedicine Association has formally urged the FDA to clarify when AI functionality within PDURS software crosses into regulated device territory, requiring a separate SaMD designation.
At the same time, the broader regulatory landscape is shifting. Under the current administration, the FDA has begun easing oversight for certain digital health products, and its 2026 withdrawal of its SaMD Clinical Evaluation guidance, previously an internationally aligned reference point, signals that software oversight is being actively re-examined. For organisations navigating PDURS, this cuts both ways: a less predictable environment increases the value of a structured, evidence-linked pathway, but that value is only fully realised if PDURS moves beyond draft. Beyond the US, the picture is even less settled: no direct European equivalent exists, and how other regions respond to the precedent being established here remains an open question that global organisations will need to navigate market by market, for now.
PDURS is not yet final policy — a framework in formation, defined enough to plan against, yet open enough that early engagement may help shape its evolution. Even in draft form, it has introduced sufficient structural change to prompt strategic reassessment across parts of the industry, and some organisations are already building for it. The competitive advantage may not lie in moving first, but in having the infrastructure, evidence, and organisational alignment in place when the framework reaches its final form.