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Docket No: FDA-2026-N-4492

Subject: Response to Request for Information: Drug Repurposing for Unmet Medical Needs

Organization: The Value-Added Medicines Alliance (VAMA)

Date: June 3, 2026

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TO: Dockets Management Staff, Food and Drug Administration

FROM: The Value-Added Medicines Alliance (VAMA)

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1. Introduction and Interest

The Value-Added Medicines Alliance (VAMA), a nonprofit association for the advocacy and education on value-added medicines such as 505(b)(2)’s, strongly supports the FDA’s initiative to advance drug repurposing as a critical tool for addressing unmet medical needs. However, based on our members' direct experience in the 505(b)(2) development pathway, we submit that scientific feasibility is currently being outpaced by severe commercial barriers. Without systemic changes to how the market recognizes and incentivizes "Value-Added Medicines" (VAMs), the most promising repurposing candidates risk abandonment. We urge the FDA to prioritize the resolution of these market access gaps to ensure that clinical innovation translates into patient benefit.

 

2. Addressing Barriers and Opportunities (Section II, Topic 4)

We have identified three critical "commercial gaps" that currently disincentivize the development of repurposed medicines.

 

A. The "Commoditization Trap" in Reimbursement

The Issue: Current payer and Pharmacy Benefit Manager (PBM) structures fail to distinguish VAMs from standard generics.

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Impact: Because a repurposed product is often identical to an existing marketed product, manufacturers cannot prevent automatic substitution at the pharmacy level. Consequently, developers cannot capture the value required to offset clinical R&D costs, effectively penalizing them for investing in evidence-based new indications.

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Recommendation: The FDA should collaborate with CMS and private payors to create a formal "regulatory designation" for repurposed products. A practical first step would be creating a separate entry and code in the FDA’s Orange Book. This would highlight the product label difference and provide clear identification that substituting or initiating substitution of another product for the approved labeled product could create an off-label promotion event by the substituting organization.

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B. Insufficient Exclusivity and Investment Risk

The Issue: While the 3-year exclusivity for new clinical investigations is valuable, it is often insufficient given today’s daunting market access timelines.

 

Impact: Institutional investors avoid assets with high "market access" risk, which limits the capital available for critical research on repurposed candidates.

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Recommendation: We encourage the FDA to optimize existing incentives, such as expanding Orphan Drug Designation (ODD) criteria or exploring "exclusivity-plus" models for repurposed drugs addressing unmet medical needs, providing a more predictable return on investment.

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C. The R&D "Knowledge Gap"

The Issue: Many repurposing projects, particularly those originating in academic settings, are undertaken without a clear understanding of market access realities.

 

Impact: This lack of commercial foresight often leads to the abandonment of projects that could have provided significant societal benefit.

 

Recommendation: VAMA recommends the creation of a formal Development Education Partnership with the FDA, modeled after the NIH/NSF I-Corps program. This partnership would:

• Educate the non-profit and academic community on commercialization hurdles early in the lifecycle.

• Provide structured guidance to map scientific development to commercial pathways, preventing "dead-end" programs.

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3. Conclusion

Scientific and societal potential of drug repurposing is vast, yet without addressing these commercial and market-access barriers, the potential remains largely untapped. VAMA is prepared to provide further data or technical insight to assist the Agency in refining these efforts. We look forward to working with the FDA to ensure that repurposed medicines reach the patients who need them most.

 

Respectfully submitted,

The Value-Added Medicines Alliance (VAMA)