New government drug repurposing programs: Opportunities and uncertainties

Area of Science:

• Pharmacology
• Drug Development
• Regulatory Science

Background:

• Drug repurposing presents a cost-effective and expedited pathway for bringing therapeutics to market compared to novel drug discovery.
• Despite its advantages, the full potential of drug repurposing remains untapped due to significant regulatory and intellectual property barriers.

Purpose of the Study:

• To examine the strategies employed by drug development programs in the United States and Europe designed to overcome challenges in drug repurposing.
• To provide an overview of policy initiatives aimed at facilitating the use of repurposed drugs.

Main Methods:

• Analysis of seven drug development programs established in the United States and Europe.
• Review of policy documents and program structures addressing regulatory and intellectual property issues in drug repurposing.

Main Results:

• Identified a range of strategies implemented across seven distinct drug development programs.
• Highlighted the diverse approaches taken by policymakers to mitigate challenges associated with drug repurposing.

Conclusions:

• Policy interventions are crucial for unlocking the benefits of drug repurposing.
• The initiatives studied offer valuable models for fostering drug repurposing in other regions.