Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT—NOTICES: Hepatitis Delta Virus Diseases not designated as an addition to the current list of tropical diseases, (May 26, 2026)

By WK Editorial Staff

To be eligible to receive a tropical disease priority review, a sponsor must submit a human drug application that is for prevention or treatment of a “tropical disease.”

In response to a suggestion by Gilead Sciences, Inc. (Gilead) that was submitted to the public docket FDA– 2008–N–0567 on February 14, 2022, the FDA analyzed whether hepatitis delta virus (HDV) infection meets the statutory criteria for designation as a “tropical disease” under Section 524 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the FDA analyzed whether there is “no significant market in developed nations” for drugs for HDV infections and whether HDV “disproportionately affects poor and marginalized populations,” both of which are statutory criteria for designation as a “tropical disease.” At this time, the FDA cannot conclude that HDV infection meets the statutory criteria for addition to the list of tropical diseases under the FD&C Act; therefore, the FDA declines to add it to the list of tropical diseases (Notice, 91 Fed. Reg. 30312 (May 22, 2026)).

Dates. May 22, 2026.

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