Digital medicine is moving fast. Faster than most teams in life sciences ever expected. And if you are inside Pfizer, watching the market shift from the sidelines is no longer an option. The shift toward PDURS has been unfolding for a few years now, and it continues to move forward in a steady, practical way. When the FDA cleared the first digital therapeutic, it confirmed that software could hold a defined role in regulated care. PDURS builds on that foundation and offers a clear pathway for situations where software supports the use of a drug. It fits naturally into how many drugmakers already think about evidence, labeling, and product support.
Over the course of more than two decades working with digital health teams, regulatory groups, clinicians, developers, and product leads, I have watched digital tools evolve through many stages. Some ideas progress quickly, others take time, and each step adds to what the industry now understands. From that experience, PDURS stands out as a practical next development. It gives organizations a structured way to connect software with a drug when there is evidence of a clinical benefit, and it aligns with the processes companies already use.
It gives drugmakers a clearer and more evidence-based pathway to pair a drug with software to improve a clinical outcome. This shift strengthens how teams design, validate, and deliver digital components that support real treatment value. It changes how you design treatments, validate outcomes, communicate value, and think about growth.
And that is exactly why Pfizer's recent move caught so much attention. It signals the start of something big. Something that will shape how digital medicine evolves across the entire industry.
What is PDURS?
If you have been following the rise of digital therapeutics and digital companions, you already know the field has been searching for a stronger path forward. PDURS provides that path.
In 2023, the FDA issued draft guidance on Prescription Drug Use Related Software, which explains how software used with a drug can contribute to improved clinical outcomes. The guidance states that if a software product, such as an app, is used with a drug and shows a meaningful improvement in a clinical outcome compared to the drug alone, that benefit may be added to the drug's label.
This is huge. A label change opens the door to real differentiation, stronger evidence, new marketing opportunities, and more predictable reimbursement. Software finally gets tied directly to the value story of the drug, instead of being treated as a separate category that struggles to fit into existing payment models.
This is also why PDURS is so different from standalone digital therapeutics. For years, DTx companies tried to commercialize digital treatments on their own. Some found success, but many faced slow adoption, limited reimbursement, and physician hesitation. PDURS solves the biggest barriers by integrating software into existing drug frameworks. Doctors already prescribe the drug. Payers already reimburse the drug. Patients already use the drug.
Now you simply provide software along with the drug that improves outcomes.
Is Pfizer Preparing for a Bigger Push Into Digital Medicine With This New Role?
A new job posting from Pfizer sent a clear signal to anyone watching digital health strategy. The company is hiring a Digital Medicine and PDURS Strategy Lead to lead a PDURS Center of Excellence. That is a strong statement. Whenever a major pharma company builds a center of excellence around a new model, you know it expects long-term value, not a side experiment.
The PDURS lead will guide cross-functional teams in designing, validating, and launching drug digital solutions that meet regulatory requirements. That means the work will not sit on the innovation shelf. It will flow directly into the pipeline and commercialization strategy. This is where things get interesting.
If Pfizer is scaling PDURS capabilities, the goal goes far beyond running pilots. They want a repeatable framework that can be applied across therapeutic areas. A system that supports evidence creation, regulatory interactions, and real clinical impact. And because Pfizer’s moves often influence market behavior, you can expect competitors to accelerate their own plans soon.
Pfizer’s Previous Activity Shows This Is Not a New Interest
The company has been quietly building its expertise for years.
Here are some key signals:
Pfizer co-chaired a committee on PDURS within the Digital Therapeutics Alliance.
The Digital Therapeutics Alliance was acquired by the American Telemedicine Association this year, and the ATA has continued to push PDURS work forward.
Edward Cox, Pfizer’s head and general manager of digital health and medicines, was recently seen on Capitol Hill with ATA leaders discussing PDURS.
In October, the American Telemedicine Association (ATA) submitted comments to the FDA asking that final PDURS guidance reduce unnecessary burdens, simplify requirements, and align with the original intent of the framework
What Kinds of PDURS Might Pfizer Build?
Pfizer has not revealed the details. That is expected. Companies rarely disclose digital strategies before the right regulatory structures are in place.
However, we have clues.
In comments about Medicare fee schedules, Pfizer addressed reimbursement for digital mental health treatments. They encouraged CMS to consider a broader set of digital tools for high-burden disease areas such as oncology and cardiometabolic management. These are areas where behavioral factors heavily influence outcomes. That makes them ideal candidates for PDURS software that can boost adherence, patient engagement, symptom tracking, and long-term disease management.
Pfizer also emphasized that CMS should restrict reimbursement to FDA-cleared products that meet established safety and effectiveness thresholds. That means Pfizer is taking PDURS seriously as a regulated pathway, not a loose interpretation of digital support tools.
Why PDURS is the Next Step
When the FDA cleared the first DTx, the industry finally had proof that software could be a regulated treatment. That moment opened the door to innovation, investment, and new research models. However, it also highlighted the challenges of commercializing pure software solutions.
Here is why PDURS matters so much:
It ties digital value directly to drug value
That solves the biggest challenge of digital therapeutics.It creates predictable reimbursement pathways
Payers know how to pay for drugs. Adding software to the label simplifies coverage.It supports real clinical impact
Software can enhance adherence, engagement, monitoring, and patient behavior in ways drugs alone cannot.It improves the drug’s competitive position
Imagine launching a drug that has stronger outcomes with integrated software compared to a competitor that lacks digital support.It reduces market friction
Physicians can prescribe a single combined treatment. Patients receive a single treatment plan. The process fits existing clinical workflows.
Turn Complex Digital Health Ideas Into Safe, High-Value Products With Estenda’s Guidance
PDURS offers enormous potential but also introduces new demands for evidence, design, validation, and regulatory readiness. This is where the right partner makes a huge difference.
At Estenda Solutions, we help Life Sciences, MedTech, and healthcare organizations turn digital health goals into practical, reliable, and sustainable solutions. Our work is built on more than 22 years of experience and over 200 completed projects focused on measurable outcomes. We combine technical depth with real-world empathy for patients, clinicians, regulators, and the teams who bring these products to life. More than 20 peer-reviewed publications back our commitment to evidence and trust.
If you want to increase value quickly, reduce project risk, and build digital solutions that genuinely help patients, we are here for you.
Contact us today at info@estenda.com to schedule your FREE 30-minute consultation with RJ Kedziora, a recognized leader in digital health!
