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
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