FDA adds four tropical diseases to priority review voucher program

In a move to encourage drug development in areas of unmet need, the US Food and Drug Administration yesterday announced the addition of Lassa fever, chikungunya virus disease, rabies and cryptococcal meningitis to the list of tropical diseases.

Applicants who submit applications for drug or biological products to prevent or treat these diseases may qualify for a tropical disease priority review voucher (PRV). A tropical disease PRV can be used to obtain priority review of a subsequent drug application that does not itself qualify for priority review.

To be eligible for a tropical disease PRV, a drug application must meet the criteria in section 524 of the Federal Food, Drug, and Cosmetic Act. The criteria include that the application must be for the prevention or treatment of a “tropical disease.” Beyond the list of “tropical diseases” in the statute, the FDA can issue an order to designate additional diseases as “tropical diseases” if the agency determines that a disease has no significant market in developed nations and disproportionately affects poor and marginalized populations.