Comment from Highlander Health
AnonymousSupportBusiness
Summary: Highlander Health expresses enthusiastic support for the FDA's efforts to advance drug repurposing and suggests adding liver disease as a priority area. They advocate for leveraging continuous real-world data (RWD), AI-based tools, and "clean room" analysis to identify repurposing candidates and streamline the regulatory process.
To the Food and Drug Administration:
Thank you for publishing the Federal Register notice entitled “Drug Repurposing for Unmet Medical Needs; Request for Information” (FDA-2026-N-4492) (the “Notice”). Highlander Health appreciates the Agency’s commitment to advancing drug repurposing efforts and embracing evidence generation techniques such as continuous real-world data generation and analysis.
Highlander Health enthusiastically supports the Agency’s work to advance its drug repurposing efforts and looks forward to collaborating with FDA, CDER, CBER, and the broader stakeholder community in advancing the field.
Please contact Nick Honig at Nickh@highlanderhealth.com with any questions regarding these comments or other issues related to evidence generation policy and infrastructure.
Sincerely,
Amy Abernethy, MD PhDBrad Hirsch, MD
Co-Founder, Highlander HealthCo-Founder, Highlander Health