PDURS: How 7 Companies and Groups Responded to the Draft Guidelines

The FDA’s Draft Guidelines for Prescription Drug Use Related Software (PDURS) have sparked considerable discussion among various stakeholders, including pharmaceutical companies, healthcare organizations, and digital health advocates. While praising and supporting the FDA’s work to issue clear guidance, most also had specific requests for additional clarity, especially about clinical trial requirements for digital health software solutions.

Here’s a summary of ten notable responses filed in reaction to these guidelines, along with links to their full comments.

1. Pharmaceutical Research and Manufacturers of America (PhRMA)

PhRMA expressed concerns that the draft guidelines may impose excessive regulatory burdens on software that supplements drug products. They recommended clearer definitions and distinctions between promotional and non-promotional labeling to avoid unnecessary compliance complexities. Download the PhRMA response

2. BIO (Biotechnology Innovation Organization)

BIO filed two responses, supporting the FDA’s effort but highlighted potential challenges in integrating PDURS with existing regulatory frameworks. They suggested that the FDA provide more detailed guidance on evidence requirements and post-market reporting. Download the BIO responses

3. Digital Therapeutics Alliance (DTA)

The DTA commended the FDA for recognizing the importance of digital health technologies but urged the agency to consider the unique nature of software products. They emphasized the need for flexible and adaptive regulatory approaches. Download the DTA response

4. Eli Lilly and Company

Eli Lilly raised concerns about the potential for increased time and cost in drug development due to the new regulations. They requested more precise guidelines on how to demonstrate the clinical benefits of PDURS. Download the Lilly response

5. Academy of Managed Care Pharmacy (AMCP)

CEO Susan A. Cantrell of the Academy of Managed Care Pharmacy (AMCP) urged FDA to consider clarifying language about the use of clinical trials as determinants, suggesting that alternative approaches, such as real-world evidence (RWE), could be used to demonstrate a clinical benefit, such as improved efficacy or safety. Download Cantrell’s AMCP response

6. Combination Products Coalition

Concerned in part that the current draft guidelines consider any digital screens shown to a user qualify under labeling review, the CPC strongly recommended that FDA clarify the PDURS definition and narrow the scope of PDURS output to patients considered to be official labeling requiring FDA approval. Download the CPC response

7. Teva Pharmaceuticals

While supporting the FDA’s intenion with PDURS, the company brought up concerns in four areas: 1) dissimilar or overburdensome regulatory requirements for similarly-situated software products; 2) concerns over cross-labeling requirements; 3) resultant procedural implementation challenges; and 4) need for additional PDURS guidance to implement the program effectively. Read the Teva response

Summary

These responses reflect a broad spectrum of perspectives, from supportive to critical, highlighting the complexity of integrating digital health technologies with traditional drug regulatory frameworks. Stakeholders are calling for clearer definitions, more detailed guidance, and greater flexibility to ensure that the benefits of PDURS can be fully realized without imposing undue burdens on the industry.

Related: 6 Ways Patients will Benefit from the FDA’s PDURS Guidelines

Let’s Talk About Medisafe and PDURS: