Understanding PDURS: A new era for digital health and pharma
The FDA's Prescription Drug Use-Related Software (PDURS) framework marks a significant milestone for healthcare in the US. Introduced to facilitate the integration of software with prescription drugs, this framework is set to transform how pharma manufacturers enhance the clinical value of their products.
During a recent webinar, Jonah Comstock, editor-in-chief at pharmaphorum, sought to demystify the new process through an insightful conversation with industry experts Marty Culjat, SVP and global head of digital medicine and regulatory innovation at EVERSANA, and Edward Cox, head and general manager of digital health and medicines at Pfizer.
The PDURS framework: an overview
A potential workaround to existing restrictions such as anti-kickback laws and rigorous drug-device combination approvals, the PDURS framework allows pharmaceutical manufacturers to add software to a drug label, provided it demonstrates clinical benefit.
"Up until now, the way to pair software with a drug was through companion apps or a drug-device combination," noted Culjat. This new PDURS framework, however, enables more flexibility and direct clinical claims about the software's benefits.
There are two primary categories within the PDURS framework, including promotional software, which does not claim clinical benefits, and required labelling, which does, Culjat explained. The latter is particularly innovative, as it allows the software to be included on drug labels, emphasising its clinical advantages. "It's a flexible approach and definitely allows you to position the product as it's intended to be," he said.
The PDURS framework, presented in 2018 and refined through public comments and draft guidance, aims to bridge the gap between digital solutions and pharmaceuticals. By allowing software that provides a clinical benefit to be included on drug labels, PDURS opens the door to a range of new possibilities for enhancing patient care and improving treatment outcomes.
Clinical and Commercial Implications
According to the speakers, one of the main attractions of the PDURS framework is its potential to address various clinical and commercial challenges faced by pharmaceutical companies. Culjat highlighted several possible use cases for PDURS, including personalised dosing, side effect management, behavioural support, and prognostics. These applications can significantly enhance the clinical value of drugs, making them more effective and safer for patients.
In addition, they underscored the potential commercial advantages including providing brand differentiation in competitive markets, maintaining treatment duration, justifying value compared to generics, and retaining brand demand longer during the lifecycle as possible positive benefits PDURS may provide.
Cox stated, "In my view, this is one of the most exciting steps that's happened at the intersection of digital and pharma in a decade."
From a commercial perspective, PDURS offers a way for branded drugs to stand out in a crowded market, particularly as they approach the loss of exclusivity.
The PDURS framework also addresses several regulatory hurdles that have traditionally impeded the integration of digital solutions with pharmaceuticals. Offering a more streamlined approval pathway reduces the time and cost associated with bringing these innovative products to market. This factor is significant for solutions that address critical issues such as personalised dosing and side effect management, where timely implementation can significantly impact patient outcomes.
Preparing for the Future: Strategic Considerations
As the PDURS framework becomes more established, both software developers and pharmaceutical companies must strategise to maximise its potential. To help organisations navigate this new terrain, Culjat provided advice for stakeholders on both sides. For software developers, he recommended identifying unmet needs within the pharma pipeline and tailoring solutions to address these gaps. "The first thing to do would be to understand where your solution can provide value," he explained. "You don't want to come at this with a solution in search of a problem," he emphasised.
Engaging with the FDA early on can also be beneficial. "It would be valuable to have that initial first level of validation on your approach with the FDA, to be able to hand that over to your partners and your discussions with pharma," Culjat advised. "The earlier you can go to the FDA and then have those discussions, the better off you would be to be able to move this forward without a lot of questions from legal and regulatory within the pharma organisation."
For pharmaceutical companies, the key lies in integrating PDURS into their broader digital health strategies. This involves not only identifying the most promising use cases but also securing internal buy-in from various stakeholders. "It's a matter of building the case, getting the brand team's engagement and interest, and then really finding the champions internally," Culjat said.
Cox highlighted the importance of bespoke solutions tailored to specific pharmaceutical assets. "These are world-class assets that deserve really crafted experiences," he stated. He noted that while a basic, off-the-shelf model might be less appealing, a tailored approach could significantly enhance the clinical and commercial value of the drug.
Additionally, the PDURS framework encourages collaboration between software developers and pharmaceutical companies. By fostering partnerships and leveraging the expertise of both parties, the framework can drive innovation and bring cutting-edge solutions to market more efficiently. This collaborative approach not only benefits the companies involved but also has the potential to improve patient outcomes on a broader scale.
The potential impact of the PDURS framework extends beyond immediate clinical and commercial benefits. By establishing a clear regulatory pathway for the integration of digital solutions with pharmaceuticals, it sets the stage for ongoing innovation in the healthcare sector. As more companies embrace this framework and develop new applications, the possibilities for enhancing patient care and treatment outcomes will continue to expand.
In closing, speakers emphasised that the PDURS framework represents a significant opportunity for innovation at the intersection of digital health and pharmaceuticals. By enabling the integration of clinically beneficial software with prescription drugs, it promises to enhance patient outcomes, streamline regulatory processes, and offer substantial commercial advantages. As the healthcare industry continues to evolve, stakeholders who embrace this new framework will be well-positioned to lead the way in digital health innovation.
Cox concluded “For nearly the first 20 years of digital health, it was hard to explain very explicitly or very clearly the benefit a digital solution could deliver.
… We had to try to navigate our way through the fog before, but if the language becomes final in the way that we all hope, that it will create a brand new clarity, and that I think it's going to make a profound difference.”
Click here to view “PDURS explained: The FDA’s new framework for adding software to drug labels” on-demand.
About EVERSANA®
EVERSANA® is the leading provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit EVERSANA.com or connect through LinkedIn and Twitter.
