By: Heather Hill, VP of Regulatory, Remepy
Highlights
- The FDA's Prescription Drug Use-Related Software (PDURS) draft guidance is a unique example of regulation spearheading technology innovation.
- PDURS is software disseminated by a drug sponsor and produces end-user output that supplements, explains, or is otherwise textually related to the drug products.
- PDURS output is classified as an FDA-required labeling when the output is essential for safe and effective product use, shows clinical benefits, or relies on data directly from a drug-device combination.
- PDURS draft guidance indicates the FDA’s acknowledgment of the therapeutic synergy between software and a pharmaceutical drug, and provides a framework for the patient treatment to include both components together.
It is typical for regulatory framework changes to lag behind technology advancements, as the legal framework for new circumstances is being created in response to an ongoing situation. However, U.S. Food and Drug Administration (FDA) draft guidance, titled Prescription Drug Use-Related Software (PDURS), is a unique example of a case in which technological innovation and regulation go hand in hand. The draft guidance, whose final version is expected in 2025, has the potential to redesign the integration of digital therapeutics and digital tools with drugs in order to maximize clinically meaningful benefits for patients. This blog post suggests an overview of the draft guidance, which is the first FDA document to address the commercial intersection of digital health and traditional drugs.
The draft guidance describes how the FDA intends to apply its drug labeling authorities to PDURS – software designed for use with prescription drugs, including software disseminated with combination products, containing both drug and device. The FDA does not seek to alter the current regulatory pathways, including those applicable to software and devices, but to add specificity to the labeling requirements for concurrent software and drug treatments.
PDURS is defined as software disseminated by or on behalf of a drug sponsor and produces an end-user output that supplements, explains, or is otherwise textually related to one or more of the sponsor’s drug products. Such end-user output could be any content that the PDURS presents to the end user (a patient, caregiver, or health care practitioner), and considered by the FDA as a type of prescription drug labeling. Labeling includes a variety of communications by sponsors about their drugs, like text, video, and audio, usually recognized as belonging to one of two categories: FDA-required labeling, which is reviewed and approved by the FDA, and promotional labeling, which generally encompasses any other labeling.
When a sponsor releases PDURS (together with a drug or a combination product), the FDA shall determine whether the end-user output constitutes an FDA-required labeling or promotional labeling, based on three factors. The first factor is whether the PDURS provides a function essential to the safe and effective use of the product. The second factor is whether evidence is provided to support a clinical benefit of the PDURS, compared to the use of the product without the PDURS. Such evidence has to be based on one or more adequate and well-controlled studies. The third factor relates only to combination products, regarding which the FDA analyzes whether the PDURS relies on data directly transferred from the device. If one of the three factors is carried out, the software output shall be considered as FDA-required drug labeling.
Considering the software output as FDA-required labeling is part of the essence of PDURS innovation, indicating that the FDA acknowledges that in some cases software usage is an integral component of the treatment, and therefore warrants inclusion in the drug labeling. The draft guidance emphasizes the increasing role of software in patient care and the comprehensive framework for evaluating the entire software-drug interaction.
PDURS draft guidance is an important regulatory stepping stone for Remepy, as our innovation relies on maximizing the combined clinical benefits of drugs and software.
