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, convened a hybrid public meeting to discuss opportunities to expand treatment options for patients by identifying new uses for approved drugs. The meeting included an overview of FDA’s drug repurposing framework and a summary of comments submitted in response to the recent Request for Information. Speakers discussed 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 brought together representatives from federal agencies, clinicians, researchers, and patient organizations.
 
The public is invited to provide written public comment addressing three key repurposing questions:
 
  1. What are examples of successful prioritization approaches from other programs or jurisdictions that could be adapted?
  2. 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.)
  3. What evidence gaps or policy/regulatory barriers most commonly hinder the advancement of promising repurposing opportunities?
 
Email up to two pages of comments to Repurposing@reaganudall.org (PDF preferred for attachments). Written comments will be accepted until August 21, 2026. Public comment on these questions is also included in the hybrid meeting for those who registered to speak in advance (deadline was July 21).
 

Agenda

10:30am

Welcome

  • Susan C. Winckler, RPh, Esq., CEO, Reagan-Udall Foundation for the FDA

10:35am

Opening Remarks

  • Brian Fahey, Senior Advisor, Immediate Office of the Commissioner, FDA

10:40am

FDA's Drug Repurposing Efforts

  • Marta Sokolowska, PhD, Deputy Center Director for Substance Use and Behavioral Health - Center for Drug Evaluation and Research (CDER), FDA

10:50am

Session 1: Snapshots of Repurposing Efforts

  • Mitra Ahadpour, MD, Deputy Director - Office of Translational Sciences, CDER, FDA
  • Matt Hall, PhD, Scientific Director, National Center for Advancing Translational Sciences
  • Heather Stone, MPH, Health Science Policy Analyst - Office of Medical Policy, CDER, FDA

11:15am

Session 2: Selection Criteria and Prioritization

  • Caroline Huang, PhD, Supervisory General Health Scientist - Controlled Substances Initiatives, CDER, FDA

Reactor Panel:

  • Susan Cantrell, RPh, MHL, CAE, CEO, Academy of Managed Care Pharmacy
  • Emily Einstein, PhD, Senior Director, Quality and Science, American Society of Addiction Medicine
  • Pam Gavin, MBA, CEO, National Organization for Rare Diseases
  • Huong Huynh, PhD, Director of Regulatory Science, Critical Path Institute
  • Janet Woodcock, MD, Former FDA Acting Commissioner

12:15pm

Break for Lunch

Lunch on your own. A list of local eateries will be available.

1:15pm

Session 3: Evidence and Submission Expectations

  • Sundeep Agrawal, MD, Associate Director of Clinical Programs, Oncology Center of Excellence, FDA
  • David Fajgenbaum, MD, MSc, MBA, Co-Founder and President, Every Cure

Reactor Panel:

  • Amy Abernethy, MD, CEO, Highlander Health
  • Marie Bradley, PhD, MPharm Senior Advisor RWE - Office of Medical Policy, CDER, FDA
  • Emily Freilich, MD, Director - Division of Neurology, Office of New Drugs, CDER, FDA
  • Donald Lo, PhD, Director of Medicines Development and Scientific Lead, REMEDi4ALL

2:15pm

Session 4: Federal Partner Discussion

Panelists:

  • Andrew Brack, PhD, Program Manager - Proactive Health Office, ARPA-H
  • Christine Colvis, PhD, Director of Drug Development Partnership Programs, National Center for Advancing Translational Sciences
  • Shari Ling, MD, Deputy Chief Medical Officer, Centers for Medicare and Medicaid Services
  • Marta Sokolowska, PhD, Deputy Center Director for Substance Use and Behavioral Health - CDER, FDA
  • Danielle Turley, PhD, Acting Director - Division of Regulatory and Quality Affairs, BARDA

3:15pm

Public Comment

  • Individuals who registered in advance to provide public comment will have 2.5 minutes for remarks
  • No direct questions will be posed to speakers or panelists

5pm

Adjourn

This project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of an award of $118,960 in federal funds (100% of the project). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA, HHS, or the U.S. Government. For more information, please visit FDA.gov.