FDA Tropical Disease Priority Review Vouchers - Complete PRV Guide

The Tropical Disease Priority Review Voucher is one of FDA's most valuable incentives for drug development. These vouchers have sold on the open market for approximately $160 million or more, creating a powerful financial incentive for sponsors developing treatments in diseases that affect the world's poorest populations.

What Is a Tropical Disease PRV?

A tropical disease PRV is a transferable voucher awarded by FDA when a sponsor gains approval for a drug or biologic that treats or prevents a qualifying tropical disease. The voucher allows its holder, whether the original sponsor or a purchaser, to convert a standard-review application into a priority review.

This cuts FDA review time from approximately 10 months down to 6 months. For blockbuster programs, those four months represent hundreds of millions in potential revenue, making PRVs extremely valuable even though they're earned through programs with minimal commercial potential.

How to Qualify for a Tropical Disease PRV

PRVs are awarded automatically at approval if your application meets all of the following criteria:

1. Treats or Prevents a Listed Tropical Disease

Your drug or biologic must address one of the tropical diseases specifically listed in the Federal Food, Drug, and Cosmetic Act (FD&C §524). The indication must clearly align with the listed disease, not a broader or adjacent condition.

2. Independently Qualifies for Priority Review

Your application must meet FDA's standard criteria for priority review on its own merits. This typically means demonstrating that your product, if approved, would represent a significant improvement in safety or effectiveness compared to existing therapies.

3. Contains No Previously Approved Active Ingredients

The application cannot contain an active ingredient, or salt or ester of an active ingredient, that has been previously approved by FDA. This ensures PRVs reward genuinely new therapies.

4. Includes a New Clinical Investigation (Post-2017 Applications)

For applications submitted after the FDA Reauthorization Act of 2017, at least one new clinical investigation must be essential to the approval. This prevents PRVs from being awarded for minor modifications or supplemental approvals.

5. Provides Required Attestations

The sponsor must submit attestations regarding global regulatory submissions and other requirements as specified under FDARA 2017.

Which Tropical Diseases Qualify?

FDA maintains a statutory list of tropical diseases eligible for PRV consideration. Examples include:

Infectious Diseases:

• Tuberculosis
• Malaria
• Human African trypanosomiasis (sleeping sickness)
• Leishmaniasis
• Dengue fever
• Chagas disease
• Zika virus disease
• Ebola and other filovirus diseases
• Chikungunya
• Rabies
• Cryptococcal meningitis

Parasitic Diseases:

• Dracunculiasis (Guinea worm disease)
• Schistosomiasis
• Lymphatic filariasis
• Soil-transmitted helminth infections

FDA may add additional diseases to this list if they meet statutory criteria, specifically diseases that have no significant market in developed nations and disproportionately impact impoverished populations.

For a complete understanding of the PRV Program and incentives, contact us.

Why Tropical Disease PRVs Matter

The transferability of PRVs creates a unique incentive structure. Even if your tropical disease program has minimal commercial value in wealthy markets, the voucher itself represents significant financial return.

For original sponsors: The PRV can be sold to pharmaceutical companies developing high-revenue products in competitive markets, generating $100-200M+ in non-dilutive capital.

For purchasers: Four months of accelerated review for a blockbuster drug can mean hundreds of millions in additional revenue and competitive advantage.

For patients: The program incentivizes investment in diseases that would otherwise be commercially neglected, bringing new treatments to underserved populations.

How Sponsors Should Evaluate PRV Eligibility

If you're developing a treatment for a tropical disease, ask these questions early in your development strategy:

Does your indication precisely match a listed tropical disease? The alignment must be clear and specific, not tangential.

Will your product independently qualify for priority review? Consider the competitive landscape and whether your therapy represents a meaningful advance.

Is this a new molecular entity? Previously approved active ingredients disqualify the application.

Can you demonstrate unmet need? This supports both priority review qualification and PRV justification.

Is your regulatory strategy structured to maximize PRV value? Consider timing, global development plans, and potential market for the voucher.

No Separate Application Required

Unlike orphan drug designation, which requires a specific request, the PRV is awarded automatically at approval if all criteria are met. However, sponsors should engage with FDA early to ensure their development program aligns with PRV requirements.

Contact us to learn more about navigating tropical disease regulatory pathways.

Common Misconceptions

Myth: PRVs are only valuable if you plan to use them yourself.
Reality: PRVs are transferable and have established market value, making them valuable even for small sponsors.

Myth: Priority review qualification is automatic for tropical diseases.
Reality: Your product must independently meet priority review criteria based on therapeutic significance.

Myth: Tropical disease PRVs are the same as orphan designation.
Reality: These are distinct programs with different criteria, though some products may qualify for both. Learn about the differences in our orphan drug designation guide.

Get Expert Guidance

Understanding whether your tropical disease program qualifies for a PRV, and how to structure your development to maximize that opportunity, requires expertise in both FDA regulations and the real-world interpretation of PRV criteria.

Only Orphans Cote works with sponsors to evaluate PRV eligibility, design development strategies that align with PRV requirements, and navigate the regulatory pathway to approval. Our team, led by Dr. Tim Cote (former Director of FDA's Office of Orphan Products Development and former Country Director for Rwanda of Center for Disease Control), has unparalleled experience in rare disease and tropical disease programs.

With a 95% first-attempt success rate for designation applications and decades of FDA experience, we understand exactly how to position your program for success.

Contact us to assess your tropical disease program's PRV potential, or explore our Orphan Minute video series for additional insights on rare disease regulatory strategies.

Frequently Asked Questions

What is a Tropical Disease Priority Review Voucher worth?

Tropical disease PRVs have historically sold on the open market for $100-200 million, with some transactions exceeding $160 million. The exact value fluctuates based on market conditions and the strategic value to potential purchasers.

Can I apply for a tropical disease PRV separately from my drug approval?

No. Unlike orphan drug designation, there is no separate PRV application. The voucher is awarded automatically at the time of approval if your application meets all statutory criteria. However, you should engage with FDA early in development to ensure your program remains aligned with PRV requirements.

Can a product qualify for both orphan designation and a tropical disease PRV?



Yes. Many tropical diseases affect fewer than 200,000 patients in the United States and would qualify for orphan designation. Some products may be eligible for both incentive programs, though they serve different purposes. Learn more about orphan drug designation eligibility.

What happens if my product doesn't qualify for priority review on its own merits?

Priority review qualification is a mandatory requirement for receiving a tropical disease PRV. If your application doesn't independently meet priority review criteria (demonstrating significant improvement over existing therapies), you will not receive a PRV even if treating a listed tropical disease.

Are tropical disease PRVs transferable?

Yes. PRVs can be sold or transferred to other sponsors. This transferability is what creates their significant market value and makes them attractive even for sponsors working on programs with limited commercial potential.

What's the difference between a tropical disease PRV and a rare pediatric disease PRV?

These are separate voucher programs with different qualifying conditions. Tropical disease PRVs apply to specific listed diseases affecting impoverished populations globally, while rare pediatric disease PRVs apply to serious or life-threatening diseases primarily affecting children (under 18) and affecting fewer than 200,000 patients in the U.S. The Rare Pediatric Disease Designation has now sunset. Please contact us to learn more about the status and potential reauthorization of the RPDD program.

Can the FDA add new diseases to the tropical disease list?

Yes. FDA may add diseases to the statutory list.

When should I start planning for PRV eligibility in my development program?

As early as possible. PRV eligibility should be considered during program design and clinical development planning. Early engagement ensures your regulatory strategy, indication definition, and clinical trial design all support PRV qualification. Contact our team to evaluate your program's PRV potential.