This blog is part of the series, A Brave New World: What’s New and What’s Next, on emerging issues, fast-moving changes, and early signals shaping the industry.

It’s not a provocative statement to say the U.S. health system is under growing strain, but the current weights are creating a powerful opening for innovative ways to provide patient care. Necessity is the mother of invention.

A looming $300B loss of exclusivity (LOE) cliff and uneven pipeline productivity are forcing the pharmaceutical industry to rethink portfolio value, while patients increasingly expect digital-first, consumer grade experiences as part of their care. Physicians, now armed with richer data and incentivized by financial mechanisms tied to monitoring, outcomes, and any solutions that can reduce administrative burden, are demanding tools that integrate seamlessly into clinical workflows. At the same time, payers are pressing harder for measurable value, accelerating the shift toward value-based care, and policy tailwinds are fueling a national race in AI-enabled drug development, wearables, and remote monitoring.

Together, these dynamics set the stage for Prescription Drug Use Related Software (PDURS) to emerge as a critical lever for extending therapeutic impact, differentiation, and value beyond the pill.

The Emerging Role of PDURS

As digital health technologies continue to evolve the field is entering an era in which regulated, therapeutic value can be delivered in cases where a drug alone may not be sufficient to achieve a desired treatment outcome. Thus, PDURS has emerged as a transformative force in modern healthcare that can enable patients to achieve improved outcomes by leveraging more effective technology in a digitally centric world.

What is PDURS?

The FDA issued draft guidance in 2023 on PDURS, where it clarified how the agency intends to apply its drug-labeling authorities to certain software outputs disseminated by or on behalf of a drug sponsor for use with a prescription drug or biologic product. PDURS, as defined by the FDA, generally includes software that:

1. Is disseminated by or on behalf of a drug sponsor, and
2. Produces an end-user output that supplements, explains, or is otherwise textually related to one or more of the sponsor’s drug products.

A software function is any distinct purpose of the software, and end-user output is any material (content) that the prescription drug use-related software presents to the end user (a patient, caregiver, or healthcare practitioner).

By this definition, examples of PDURS can encompass solutions anywhere from companion apps or branded web tools for treatment and dose selection, to safety and Risk Evaluation and Mitigation Strategies (REMS) software. However, the most exciting part of the PDURS draft guidance is how FDA clarifies that the benefit from the software function may be added to the drug label.

The software benefit may be added to the drug label if the PDURS offers demonstrated evidence:

1. Of 'clinically meaningful benefit' when using drug + software, compared to drug alone, or
2. That PDURS is essential for safe and effective use of the drug.

Without such evidence submitted and reviewed by the FDA, the manufacturer may not promote the clinical value of the software.

Why This Matters

Inclusion of the software benefit within the drug label directly enhances the therapeutic and commercial value of the drug, as it can now make new and/or improved clinical claims. Importantly, the FDA has already reviewed evidence showing that software can deliver clinically meaningful benefit on top of drug therapy.

In its De Novo review of Click Therapeutics’ digital therapeutic, CT 132, for Migraine, FDA evaluated data demonstrating improved outcomes when a digital intervention was added to standard pharmacologic care, mirroring the exact evidentiary bar PDURS is designed to meet.

What This Means: The opportunity

Before PDURS, digital therapeutics (DTx) were used as either standalone or adjunctive therapies -- prescribed, utilized, and reimbursed separately -- without the opportunity to realize their full therapeutic potential as a synergistic enabler in therapy.

Today’s healthcare software typically comes in the form of companion apps or well-being solutions that are limited to the wellness claims that they provide. Even as a general-use DTx, the software may be limited to low-risk, indication-specific claims.

Through PDURS and with the software regulated as a Software as a Medication Device (SaMD), the added clinical benefit can now be integrated directly into the official drug label, which strengthens the therapeutic and commercial value proposition of the drug asset.

Potential commercial and therapeutic opportunities for pharma manufacturers could include, but are not limited to, increased efficacy, safety, market differentiation, and patient engagement.

Potential Use Cases

Consider the current landscape of cancer treatment. While we are seeing unprecedented innovation at the molecular level designed specifically to suppress tumor growth and drive clinical remission, the molecule alone often fails to address the patient's holistic experience. While the drug performs its specific biochemical task, the patient is frequently left to navigate a secondary human crisis. This includes debilitating mental health hurdles such as anxiety and depression, profound social isolation, and the constant physical toll of medication side effects and adverse events.

This is where medical-grade software acts as a critical, synergistic enhancer for the molecule. By integrating digital interventions, such as real-time symptom tracking and cognitive behavioral support, pharma can provide the psychological and operational scaffolding necessary to complete the therapy. Together, the drug and the software function as a unified treatment system to deliver a superior therapeutic outcome that is safer and more engaging. For Pharma manufacturers, this represents a strategic opportunity to capture value by demonstrating a clinically meaningful benefit that extends far beyond the chemical asset itself.

This is not just theory. Click Therapeutics has demonstrated data in a randomized control trial (RCT) that it’s novel Multimodal Multistable Bias Modification (MMBM) smart phone intervention for breast cancer patients demonstrated reduction in fatigue, anxiety, and depression symptoms. By the definition of PDURS, if Click’s MMBM demonstrates this clinical benefit when used with a specific drug, that added benefit may be added to the sponsor’s drug label.

How This Will Manifest in Labeling

In order to better understand this, we need to revisit the importance of labeling and claims:

• Promotional Labeling
  What is it? Statements in promotional labeling are generally limited to factual descriptors of the product (e.g., function of the product), not outcomes resulting from its use. It must be truthful, balanced, and consistent with the FDA-approved labeling.
  
  Example Promotional Message * No treatment benefit claims *
  
  "Navigate your treatment journey with [App name]. This app provides personalized mindfulness exercises to help manage the anxiety often associated with cancer therapy, along with tools to track your daily mood and social engagement."
  
  The Limit: Prescription Drug Use-Related Software (PDURS) that lacks demonstrated evidence of added clinical benefit—or is not required for the safe and effective use of the drug—is restricted to this promotional category. It acts as a companion but does not inherently "unlock" new clinical value for the molecule.
• FDA-Required Labeling
  What is it? The FDA-Required Labeling serves as the official source of truth for the regulated product’s safe and effective use. It refers to the comprehensive, scientifically vetted information about a drug product that has been reviewed and approved by the FDA as part of its marketing application review process, serving as the official source of truth for its safe and effective use.
  
  Example Drug Label * Treatment benefit claims *
  
  “This [Software-Enhanced Drug™ Name], comprised of [App Name] and [Oncology Drug Name], is indicated for the treatment of adult patients with [Specific Cancer]. In clinical trials, this combination therapy demonstrated a statistically significant reduction in in Progression-Free Survival (PFS) and Overall Response Rate (ORR) – while also demonstrating a statistically significant reduction in comorbid depressive symptoms and improved overall quality-of-life scores compared to patients receiving [Oncology Drug Name] alone."
  
  The Opportunity: PDURS with demonstrated evidence of added clinical benefit enables Pharma to update the drug label. This allows the brand to make new clinical claims, directly enhancing the therapeutic and commercial value proposition of the molecular asset.

The Future

So then, how should pharma be thinking about moving forward to capitalize on PDURS? We have highlighted a couple of guiding principles:

• Critically, still focusing on identifying digital health solutions grounded in the unmet need that needs to be solved for patients/health care providers/health systems and which maps back to pharma’s company, asset, and brand objectives
• Establishing enterprise processes with cross-functional buy-in (clinical and commercial asset and brand leaders, digital health, technology, regulatory, legal/compliance) to determine where in the portfolio is best fit for PDURS solutions and their implications
• Acquiring voice of user (particularly patients and healthcare professionals) inputs on the value proposition of PDURS and pressure-testing solution concepts
• Planning early (ideally by Phase II) to formulate regulatory and reimbursement pathways to accelerate timelines and ensure commercial impact, and to ensure an integrated evidence plan
• Addressing operational and clinical workflow (integration into EHRs/e-prescribing) implications to drive adoption at scale

Ultimately, the promise of PDURS for pharma can be thought of in two main impactful ways: improving patient safety and improving patient outcomes, which underscores the shift towards understanding the patient as a consumer. Patient safety focuses on helping patients manage side effects and improve tolerability, while patient outcomes focus on achieving either the same clinical endpoint as the drug or a distinct endpoint specific to the PDURS. Evidence-backed Software as a Medical Device (SaMD) and DTx can be the catalysts to create this therapeutic benefit for a specific pharma drug. This represents a meaningful opportunity for pharma to finally fully capitalize on the original “beyond the pill” promise.

Click Therapeutics is the market leader in developing potential PDURS solutions. IQVIA is advising life sciences clients on how to best navigate this new world and successfully bring these solutions to market with the shared goal of improving patient outcomes and experiences. Please reach out to the authors to learn more and discuss how PDURS can enhance your organization’s commercial impact.