November 2015

This week, the ATS joined a letter to the chair and ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, urging the committee to improve an Food and Drug Administration (FDA) neglected diseases incentive by requiring development of novel products for the awarding of vouchers and that the program ensures affordable access to new drugs for patients.

The Priority Review Voucher (PRV) Program for Neglected Diseases was created in 2007 and aims to incentivize the development of new therapies and vaccines for neglected diseases, such as tuberculosis, by providing companies with a priority FDA review voucher that can be transferred and applied to other drugs.

The letter, led by Medecins Sans Frontieres and the TB Alliance and signed by seven other organizations, points out that "Despite representing more than 10 percent of the global disease burden, only 4 percent of new drugs and vaccines approved across the world were indicated for neglected diseases between 2000 and 2011." The letter continues, "Improvements to the PRV program will be one important step toward broader changes that are urgently needed to ensure the R&D system delivers appropriate and affordable health technologies for those who need them."

The letter urges the HELP Committee to make the improvements to the PRV program for neglected diseases in the committee's upcoming research innovations legislation, expected to be unveiled in December.