ROCKVILLE, Md., Sept. 23 /PRNewswire/ -- Today, U.S. scientists committed to finding answers to reducing and eliminating what are known as neglected tropical diseases (NTDs) that plague the world's poorest people in developing countries, urged the FDA to include in its orphan classification the neglected infections of poverty that also affect Americans, and expressed support for stronger relationships with the FDA to ultimately halt these ancient scourges.
In testimony presented at the FDA hearing, Advancing the Development of Medical Products Used in the Prevention, Diagnosis, and Treatment of Neglected Tropical Diseases, Peter J. Hotez, MD, PhD, and President-Elect of the ASTMH, offered recommendations for the FDA's consideration that based on its unique regulatory and public health role could position the agency to more effectively address these diseases and conditions.
"The science and manufacturing associated with producing safe and effective treatments is complex," said Hotez, who, is also President, Sabin Vaccine Institute and Chair, Department of Microbiology, Immunology, and Tropical Medicine, George Washington University. "However, perhaps more daunting are the operational logistics and economic barriers to bringing critical treatments to affected populations."
Most not-for-profit organizations and academic institutions would welcome additional guidance in working with the FDA and the national regulatory authority (NRA) in countries where these diseases and conditions are almost part of the landscape. Similarly, because there are no major economic markets for drugs to treat NTDs in the U.S., Europe or Japan, most major pharmaceutical companies are equally less likely to conduct their own R&D into these health issues. While a small group of non-for-profit organizations, Product Development Partnerships (PDPs), have stepped into this void to develop new commercial entities for the NTDs, they are significan