PDURS explained: The FDA’s new framework for adding software to drug labels

The US FDA has recently proposed a new draft framework that enables pharma manufacturers to add software to a drug label if they can demonstrate that the software adds clinical benefit to the drug. This prescription drug use-related software (PDURS) framework would allow for the pairing of a companion app to a drug without restrictions of anti-kickback laws and/or the rigour of drug-device combination approvals, while supporting greater clinical value, brand differentiation, and extended lifetime value.

In a first-of-its-kind fireside chat, pharmaphorum editor-in-chief Jonah Comstock will sit down with Marty Culjat, SVP, global head of digital medicine and regulatory innovation at EVERSANA and Ed Cox, head and general manager of digital health and medicines (DHM) at Pfizer, to get the word out about this new regulatory paradigm and discuss its potential impact on the pharmaceutical industry.

The new PDURS framework is poised to change the way pharma thinks about companion apps, digital medicines, and digital therapeutics. However, to unlock its potential, digital leaders in the pharma industry need to know what the framework is, how it works, and how it can be of use to them. Benefit from our speakers’ unique perspectives at the intersection of pharma and government as you get the skinny on this new way of regulating drug-related apps.

Impact of new Prescription Drug Use Related Software (PDURS) Framework on pharma brands

In this pharmaphorum webinar, brought to you by EVERSANA, Culjat will briefly explain the PDURS framework before he and Cox launch into a fireside chat moderated by Comstock. Finally, there will be time for a short question and answer session.

This webinar is a chance to learn the basics of the new PDURS framework, but also an opportunity to put it in context and start to understand how it might change the landscape of digital in pharma. Join us on Tuesday 9th July07:00am PDT / 10:00am EDT / 15:00pm BST / 16:00pm CEST as the team discusses:

• The status quo for drug-related software
• Overview and current status of the PDURS framework
• The regulatory and clinical requirements to achieve promotional and FDA-required labeling of PDURS software
• The potential commercial impact of PDURS on brands
• How to engage functional groups in pharma companies of all sizes to pursue PDURS
• Various use cases for PDURS software
• How to engage with the FDA on PDURS

Don’t miss this chance to be on the cutting edge of a new regulatory pathway for apps and digital tools that could unlock their potential like never before.

About the speakers

Marty Culjat, PhD is the SVP, global head of digital medicine and regulatory innovation at EVERSANA. In this role, he leads a cross-functional team supporting the commercialisation of digital medicine products within companies ranging from start-ups to large pharma. He is widely recognised as an expert in regulatory affairs and strategy in digital health, having supported more than 50 companies in this area over the past few years, serving as the de-facto regulatory head of digital health within multiple large pharma companies, and serving as a thought leader at various international conferences at the intersection of digital health and pharma. Dr Culjat has a PhD in Biomedical Engineering from UCLA and BS in Bioengineering from UC San Diego.

Edward Cox is an innovative, inspiring, and relentless life sciences and digital health executive and has been committed to advancing the digital health sector as it strives for patient outcomes, clinical results, and commercial viability. He currently serves as head & general manager of Digital Health & Medicines (DHM) at Pfizer. At Pfizer, Cox has led the creation of one of the first commercial digital health business unit within pharma. In addition, he is collaborating with Pfizer’s government affairs teams and external existing organisations to generate pathways for the reimbursement of digital therapeutics. He holds an MS in Management from the Warrington College of Business at the University of Florida, as well as a BS in Telecommunications from the University of Florida.

Jonah Comstock, editor-in-chief at pharmaphorum (moderator), is a veteran digital health journalist who now covers the pharmaceutical sector more broadly. An early hire at MobiHealthNews, he most recently led editorial efforts at HIMSS Media before coming to pharmaphorum in 2022. He holds an Master's in Journalism from Columbia University and a Bacherlor's in English and Philosophy from The College of Wooster.