Drug Repurposing:
Considerations for Selection Criteria and Prioritization
Hybrid Public Meeting
August 5, 2026 | 10:30am-5pm (eastern)
Drug repurposing offers the opportunity to expand treatment options for patients by identifying new uses for approved drugs. By leveraging established safety profiles, manufacturing capacity, and clinical experience, repurposing has the potential to accelerate patient access to effective therapies. Drug repurposing was named as a priority in the Make Our Children Healthy Again Strategy Report: “The NIH and FDA will jointly investigate opportunities to strengthen the use of repurposed drugs for the treatment of chronic disease, while harmonizing authorization processes through collaborative clinical trial designs to achieve FDA approval.”
The Foundation, in collaboration with the U.S. Food and Drug Administration, will convene a hybrid public meeting to discuss opportunities to expand treatment options for patients by identifying new uses for approved drugs. The meeting will include an overview of FDA’s drug repurposing framework and a summary of comments submitted in response to the recent Request for Information. Speakers will discuss potential approaches for prioritizing and selecting promising candidates for drug repurposing, including the use of real-world data/evidence and artificial intelligence (AI), while maintaining the requirement for substantial evidence of effectiveness. The meeting will bring together representatives from federal agencies, clinicians, researchers, and patient organizations.
The public is invited to provide brief public comments addressing three key repurposing questions:
- What are examples of successful prioritization approaches from other programs or jurisdictions that could be adapted?
- What factors should organizations consider when selecting repurposing candidates, and how should these factors be prioritized in the decision-making process? (Factors might include unmet medical need, strength of evidence, disease burden, potential public health impact.)
- What evidence gaps or policy/regulatory barriers most commonly hinder the advancement of promising repurposing opportunities?
The deadline to request to present public comment is Tuesday, July 21, 2026. Comments can be made by in-person and virtual attendees. The Foundation will work to ensure a variety of representative voices can be heard. Those who request to present public comment will be notified by the close of business on Friday, July 24. If you prefer to submit written comments to the Foundation, email up to two pages of comments to Repurposing@reaganudall.org (PDF preferred for attachments).
This is a hybrid event with options to attend virtually or in person at 1333 New Hampshire Ave., NW, Washington, DC. Please note that in-person seating is limited.