Tufts Report Concludes that Product Approvals for Neglected Diseases are on the Rise

By Kurt R. Karst –      

A recent Impact Report (subscription required) from the Tufts Center for the Study of Drug Development (“CSDD”), titled “Drug approvals for neglected diseases increase along with more R&D funding,” concludes that new products to treat neglected diseases (such as malaria, kinetoplastids, diarrheal diseases, roundworm, bacterial pneumonia and meningitis, and typhoid and paratyphoid fever) have received marketing approval from regulatory agencies at a steadily increasing rate in the past several years as research and development  funding for neglected diseases has dramatically increased.  The report is based on research conducted by CSDD Senior Research Fellow Joshua P Cohen.  

Among other things, CSDD found that:

• The annual rate of new product approvals for neglected diseases increased from an average of 1.8 in 1975-1999 to 2.6 in 2000-2009;

• Between 1999 and 2008, annual funding for neglected diseases rose from less than $100 million annually to more than $2.5 billion today, and today government research and development funding accounts for 69% of all neglected disease product development funding, with non-profit organizations and the drug industry contributing 21% and 10%, respectively;

• Vaccines have displaced drugs as the primary products being developed for neglected diseases, and products to treat HIV/AIDS and malaria accounted for 81% of negelected disease approvals from 2000-2009;

• Public-private partnerships for new product development accounted for 46% of all approvals to treat neglected diseases in 2000-2009, which is up from 15% in 1975-1999.

A provision included in the Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act of 2010, Pub. L. No. 111-80, could also lead to a greater number of products approved to treat neglected diseases in the coming years.  As we previously reported, § 740 of the law requires FDA to establish within the Agency “a review group which shall recommend to the Commissioner of Food and Drugs appropriate preclinical, trial design, and regulatory paradigms and optimal solutions for the prevention, diagnosis, and treatment of neglected diseases of the developing world.”  FDA is also required to submit a report to Congress on the review group’s findings and recommendations, and to issue guidance and develop internal review standards based on those recommendations.