Doc­tors With­out Bor­ders say FDA's PRV in­cen­tive is mis­used; Te­va drug wins FDA OK on tar­dive dysk­i­ne­sia

⇨ A non­prof­it group in­clud­ing Chemo Group won the first FDA ap­proval for an old Cha­gas drug, pledg­ing to make it avail­able at low cost to pa­tients. But Doc­tors With­out Bor­ders (MSF) says the pri­or­i­ty re­view vouch­er they won in the process — like­ly worth more than $100 mil­lion — sim­ply un­der­scores how bad­ly that in­cen­tive has worked for pa­tients. “The fact that a com­pa­ny can re­ceive an in­no­va­tion award for reg­is­ter­ing a med­i­cine that has been used to treat Cha­gas for years shows how far re­moved we are from the orig­i­nal in­tent of this pro­gram,” said Jen­nifer Reid, ad­vo­ca­cy and re­search of­fi­cer at MSF. “Peo­ple suf­fer­ing from Cha­gas and oth­er ne­glect­ed dis­eases still des­per­ate­ly need in­no­va­tion and new re­search to save their lives and im­prove treat­ment and pre­ven­tion op­tions. They should be able to use and af­ford these med­i­cines no mat­ter where they live. Be­fore a com­pa­ny can re­ceive this prize, U.S. Con­gress should man­date that on­ly new med­i­cines re­ceive a PRV and that com­pa­nies en­sure ac­cess and af­ford­abil­i­ty for all pa­tients.”

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