FDA issues four notices regarding tropical disease list

Today, the U.S. Food and Drug Administration added three diseases to the current list of tropical diseases for the purposes of obtaining a tropical disease Priority Review Voucher (PRV) and declined to add two other diseases.

The orders and notices announcing FDA’s determinations can be found here:

• Decision Not to Designate an Addition to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act: Coccidioidomycosis
• Decision Not to Designate an Addition to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act: Clonorchiasis
• Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act - Opisthorchiasis and paragonimiasis
• Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act - Brucellosis

FDA is adding opisthorchiasis, paragonimiasis and brucellosis to the list because the agency determined that these three diseases meet the statutory criteria for designation as tropical diseases because no significant markets exists for the treatment or prevention of these conditions in developed nations and the three diseases disproportionately affects poor and marginalized populations around the world.

The agency has determined that coccidioidomycosis does not meet the statutory criteria for designation as a tropical disease eligible for PRV consideration because of the potential significant market for preventive products for coccidioidomycosis in the United States. Therefore, FDA declines to designate coccidioidomycosis as an addition to the list of tropical disease PRV-eligible diseases at this time.

The agency has determined that clonorchiasis does not meet the statutory criteria for designation as a tropical disease eligible for PRV consideration because of the potential significant market for clonorchiasis in developed nations. Therefore, FDA declines to designate clonorchiasis as an addition to the list of tropical disease PRV-eligible diseases at this time.

Drugs and biological products approved for the prevention or treatment of diseases on the tropical disease list (including both the statutory list and any diseases designated as tropical diseases by FDA) may be eligible to receive a tropical disease PRV if they meet certain statutory criteria.

Sponsors can use PRVs to obtain priority review designation for a subsequent drug or biological product marketing application that would not otherwise qualify for priority review designation on its own merits. “Priority review” means that FDA’s goal is to take action on the marketing application within six months of filing, compared to 10 months for a “standard review.” This shortened review timeframe means that the PRV holder potentially could begin marketing its drug or biological product sooner than it would have without the PRV, thereby increasing sales revenue. The tropical disease PRV program is intended to act as an incentive to encourage the development of new drugs and biological products for the prevention and/or treatment of certain diseases that affect millions of people throughout the world.

For more information about the tropical disease PRV program, please see the guidance for industry titled “Tropical Disease Priority Review Vouchers.”