FDA Should Reform Priority Review Program To Encourage R&D Of, Access To New NTD Treatment, Prevention Options
POLITICO: The Zika loopholes
Willo Brock, senior vice president of external affairs for the Global Alliance for TB Drug Development; Rachel M. Cohen, regional executive director for the Drugs for Neglected Diseases Initiative North America; Jason Cone, executive director of Médecins Sans Frontières (MSF)-USA; and Lindsay McKenna, TB/HIV project officer for the Treatment Action Group
“…In November, seven global health organizations sent a letter to Senate Committee on Health, Education, Labor, and Pensions leadership asking them to fix critical flaws in the [FDA’s 2007 R&D program] by introducing a requirement that the products earning a [priority review voucher (PRV)] be new and accessible to the people who urgently need them. Now, as the House considers adding Zika to the list of neglected diseases eligible for a PRV, this is a unique opportunity to restore the original intent of the program. Lawmakers should add two provisions to the bill, one requiring that PRVs only be granted to products that are truly novel in terms of introducing new therapeutic or preventative options for patients, and the other requiring companies to consider how products to treat or prevent neglected diseases will be made available and affordable to the people affected by neglected diseases. These changes will help ensure that the PRV program achieves what it should: Encourage investment in innovative products, and make them available to the communities and treatment providers who need them most” (3/25).