How PDURS is beginning to reshape therapeutic value, and what it may demand 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 The FDA’s draft guidance, published in September 2023, does not simply regulate software that sits alongside drugs.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 helps to understand what came before it. The first-generation DTx movement generated genuine scientific progress and genuine commercial frustration in roughly equal measure. 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. But realising that potential demands something that commercial teams alone cannot deliver. Software-enabled therapeutics sit at the intersection of R&D, regulatory, clinical, medical affairs, and commercial functions, and traditional vertical organisational structures are not well configured to deliver them. Evidence generation, regulatory engagement, scientific communication, and commercial positioning all need to 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.
The Moment Before the Map Is Drawn
It is worth pausing on where PDURS actually stands. As of March 2026, the guidance remains in draft form, with no finalised policy and no definitive timeline. A range of 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, 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 called on the FDA to clarify when AI functionality within PDURS software crosses into regulated device territory, requiring a separate SaMD designation. How the FDA answers that question will have significant implications for how drug-digital programmes are architected and validated going forward.
What is emerging, then, is a framework still very much in formation. Defined enough to plan against, yet unfinished enough that the organisations engaging now may have a hand in shaping what it ultimately becomes. Beyond the US, the landscape is even less settled: no direct European equivalent exists, and how other regions respond to the precedent being established here remains an open question — one that global organisations will need to navigate market by market, for now.
PDURS is not yet final policy. But even in draft form, it has introduced enough structural change to prompt strategic evaluation within parts of the industry. Whether this translates into sustained investment, organisational redesign, or pipeline reprioritisation remains to be seen. What is clear is that some organisations are already building for it, and the competitive advantage may not lie in moving first, but in being prepared when the map becomes clearer.