FDA Says Hepatitis Delta Is Not Tropical Enough
Published Date: 5/22/2026
Notice
Summary
The FDA decided not to add Hepatitis Delta Virus (HDV) to the list of tropical diseases because it doesn’t fully meet the rules about market size and who it affects. This means drug makers won’t get special priority review vouchers for HDV treatments right now. People working on HDV drugs should keep an eye out for future updates but won’t see changes or new incentives immediately.
Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
No Priority-Review Vouchers for HDV Now
On May 22, 2026, the FDA decided not to add Hepatitis Delta Virus (HDV) infection to the list of "tropical diseases" under Section 524 of the Federal Food, Drug, and Cosmetic Act. That means sponsors developing HDV prevention or treatment drugs are not eligible for tropical disease Priority Review Vouchers (PRVs) at this time, so they will not receive that special FDA priority-review incentive immediately.
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