Navigation Links
American Society of Tropical Medicine and Hygiene (ASTMH) Calls for Stronger FDA Science Investment to Better Fight Diseases of Poverty Worldwide
Date:9/23/2010

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 significantly under-resourced.

"The FDA can help enormously by increasing its guidance and mentorship to PDPs to help them meet the needs of NRAs and the FDA as well as finding ways to operationalize more efficiently," said Hotez.  "These organizations would also welcome increased financial support for NTD product development and testing, and an expansion of FDA's Orphan Grants Program in the Office of Orphan Products Development."  

Of the $3 billion global budget allocated for neglected disease R&D, more than 70% of the budget is allocated to the "big three" – HIV/AIDS, malaria, and tuberculosis, leaving less than 30% of the total budget to address other NTDs.  

NTDs also afflict many of the most impoverished, even in the U.S.  For instance, millions of Americans living in the poorest areas of the Mississippi Delta, the border with Mexico, inner cities, and Appalachia are at risk for parasitic and other infections, and in recognition that there is a need to address the special status of these conditions, the Neglected Infections of Impoverished Americans Act of 2010, H.R. 5986 was just introduced in Congress.

About NTDs and the Neglected Infections of Poverty

NTDs are 13-14 major chronic parasitic and related infectious diseases that are for the most part ancient conditions that have been affecting humans for thousands of years.  They are most common in developing countries in Africa, Asia, and Latin America, and most frequently affect the world's poorest people – for example, subsistence farmers and those living in urban slums.  These diseases promote poverty and stunt economic development individually, as a community and a nation.  Common NTDs are Ascariasis, Trichuriasis, Hookworm, Schistosomiasis, Onchocerciasis, Sleeping Sickness, Trachoma and Enteric Infection. Related neglected infections of poverty in the U.S. include conditions such as toxocariasis, trichomoniasis, toxoplasmosis, cysticercosis, Chagas disease, congenital cytomegalovirus infection, and dengue fever.  For more information, visit www.astmh.org.

About this FDA Public Hearing

The FDA hosted this hearing to solicit general views and information from interested persons on issues related to advancing the development of medical products (drugs, biological products, and medical devices) use in the prevention, diagnosis, and treatment of neglected tropical diseases.  In particular, the meeting focused on preclinical studies, trial design, regulatory approaches, and optimal solutions as they relate to neglected tropical diseases.

About the ASTMH

ASTMH, founded in 1903, is a worldwide organization of over 3,000 scientists, clinicians and program professionals whose mission is to promote global health through the prevention and control of infectious and other diseases that disproportionately afflict the global poor.  Original scientific advancements in global health are published in the ASTMH's journal, the American Journal of Tropical Medicine and Hygiene.


'/>"/>
SOURCE ASTMH
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
2. Lexicon to Present Research Results at American Chemical Society Meeting Regarding Target of LX1031 Drug Candidate
3. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
4. Aspirin Named 8th World Wonder by Majority of Americans
5. MedImmunes Motavizumab Reduced RSV Hospitalizations by 83 Percent Among High-Risk Native American, Full-Term Infants in Placebo-Controlled Phase 3 study
6. American Heart Association Comment Saving Lives in Type 2 Diabetics: Could It Be as Easy as Lowering Blood Pressure?
7. TrialCheck(R) Cancer Clinical Trial Matching Interface to Debut on American Cancer Society Web Site
8. Hypertension: Journal of the American Heart Association Rapid Access Reports: Hispanics Hypertension Better Controlled With Equal Access to Care
9. Positive Results for NKTR-118 (oral PEG-naloxol) Presented at American Academy of Pain Management Meeting
10. Preimplantation Genetic Diagnosis International Society Refutes American Society of Reproductive Medicine Opinion - States Preimplantation Genetic Screening is Beneficial When Performed in Experienced Centers
11. New MIRCERA(R) Data Analyses to be Featured at the American Society of Nephrology Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... , 12 februari 2016 AAIPharma ... toonaangevende leverancier van productie en ontwikkeling op ... kondigt vandaag een uitbreiding aan van steriele ... locatie in Charleston, SC ... tot meerdere recente investeringen. http://photos.prnewswire.com/prnh/20150806/256637LOGO ...
(Date:2/12/2016)... BUDAPEST , Ungarn, February 12, 2016 ... ein Medizintechnikunternehmen, das sich auf den ungedeckten ... gab heute positive Ergebnisse seines klinischen Forschungsprogramms ... und Asthma-Patienten beschäftigt, ergab Verbesserungen ihrer respiratorischen ... Indiso ltd , ein Medizintechnikunternehmen, das ...
(Date:2/11/2016)... 2016 - Cardiac Marker ... Medicine and Cancer Therapy. - European Point of ... Markets. - Key Diagnostic Testing Markets. - ... in Genetic Testing. - Molecular Diagnostics in Infectious ... Over-the-Counter Diagnostic Products World Markets. - Point of ...
Breaking Medicine Technology:
(Date:2/12/2016)... ... February 12, 2016 , ... Young Asset Protection, ... the beginning of the latest charity campaign in their community enrichment program. Art ... to this worthy cause are currently being accepted at: http://artexpressioninc.org/ . , ...
(Date:2/12/2016)... ... ... Miami Dental Specialists is excited to bring patients the choice of ceramic, ... Miami Dental Specialists will offer the non-metal implants as a safe, holistic and hygienic ... by the dental implant manufacturer, Straumann, to bring this cutting-edge technology to Miami. ...
(Date:2/12/2016)... ... February 12, 2016 , ... J Thomas & ... continuing it’s commitment to act as Agents of Change in the community, announces ... area homeless families to fulfill immediate needs and help them move into permanent ...
(Date:2/12/2016)... ... February 12, 2016 , ... ... foods choices that promote eye health. These articles generally list between five and ... health advocate Sharon Kleyne endorses every one of these lists and believes that ...
(Date:2/12/2016)... ... February 12, 2016 , ... Homeowners now have ... possibilities. CertainTeed, North America’s leading brand of building products, has improved upon its ... in the mobile version of the ColorView® Exterior Style and Color Selector. Created ...
Breaking Medicine News(10 mins):