Tropical Disease Priority List Expanded by FDA

The U.S. Food and Drug Administration (FDA) announced the addition of Lassa fever, chikungunya virus disease, rabies and cryptococcal meningitis to its list of tropical diseases.

“Today we’ve added four diseases to a program designed to encourage the development of new drug and biological products to prevent or treat certain tropical diseases affecting millions of people throughout the world,” said FDA’s Chief Scientist RADM Denise Hinton, in a press release. 

The diseases added today by the FDA are:

• Lassa fever
• Chikungunya virus disease
• Rabies
• Cryptococcal meningitis

“Tropical diseases cause a significant health burden globally. Yet, there has been remarkably little progress over the past 50 years in drug and biologic development to treat and prevent these diseases,” said Hinton. 

“Although tropical diseases generally are uncommon in the United States, tourism, immigration, and military operations are increasing the direct effect these diseases can have on the health of Americans.”

According to a recent study, over the past decades, Gulf Coast storms may have empowered the spreading of neglected tropical diseases (NTDs), such as West Nile, Chagas, Chikungunya, Typhus and Dengue viruses to thrive, said Dr. Peter Jay Hotez, from the Baylor College of Medicine, author of Vaccines Did Not Cause Rachel's Autism: My Journey as a Vaccine Scientist, Pediatrician, and Autism Dad.

NTDs impair physical and cognitive development, and can contribute to mother and child illnesses and death, says the Centers for Disease Control and Prevention (CDC).

Further analysis by Dr. Hotez reveals that up to 4 million of the 60 million people living in 5 Gulf Coast states; Texas, Louisiana, Mississippi, Alabama, and Florida, are affected by at least 1 NTD.

Also, there are concerns about the possible return of West Nile virus to the USA.

Since the summer of 1999, West Nile virus has quietly spread to most states in the USA. More than 46,068 West Nile virus (WNV) cases and 2,018 deaths have been reported through 2016.

As of July 24, 2018, a total of 45 states have reported 231 West Nile cases in people to the Centers for Disease Control and Prevention (CDC).  

Of these WNV cases, 62 (58%) were classified as neuroinvasive diseases, such as meningitis or encephalitis.

These tropical diseases will be added to the current list, which includes:

• Tuberculosis
• Malaria
• Blinding trachoma
• Buruli ulcer
• Cholera
• Dengue/Dengue hemorrhagic fever
• Dracunculiasis (guinea-worm disease)
• Fascioliasis
• Human African trypanosomiasis
• Leishmaniasis
• Leprosy
• Lymphatic filariasis
• Onchocerciasis
• Schistosomiasis
• Soil-transmitted helminthiasis
• Yaws
• Filovirus Diseases
• Zika Virus Disease
• Chagas disease (August 20, 2015, final order)
• Neurocysticercosis (August 20, 2015, final order)

With the tropical disease priority review voucher program, Congress intended to stimulate the development of drugs and biologics to prevent and treat infectious diseases for which there are no significant markets in developed nations and that disproportionately affect poor and marginalized populations.

Applicants who submit applications for drug or biological products to prevent or treat these diseases may qualify for a tropical disease priority review voucher.

For additional information regarding this FDA program, please visit this site.