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 Food and Drug Administration (FDA or Agency) has 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 Agency has 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 Agency cannot conclude that HDV infection meets the statutory criteria for addition to the list of tropical diseases under the FD&C Act; therefore, FDA declines to add it to the list of tropical diseases.
US Federal Register - FDA Guidance Notices · May 22, 2026
Notice of Decision Not To Designate Hepatitis Delta Virus Diseases as a Tropical Disease
Original title: Notice of Decision Not To Designate Hepatitis Delta Virus Diseases as an Addition to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act
FDA declines to designate hepatitis delta virus infection as a tropical disease under Section 524 of the FD&C Act.
Published by US Federal Register - FDA Guidance Notices. HealthSignal links to the original document; the summary above is extracted from the source text.