Trop­i­cal dis­ease PRV fix didn’t stop No­var­tis from win­ning an­oth­er

Back in 2017, a new law was en­act­ed, known as the FDA Reau­tho­riza­tion Act (FDARA), which con­tained not on­ly the new user fee pro­grams for phar­ma­ceu­ti­cals, med­ical de­vices, gener­ics and biosim­i­lars, but al­so a slight tweak to the trop­i­cal dis­ease pri­or­i­ty re­view vouch­er (PRV) pro­gram.

The change was meant to en­sure that com­pa­nies win­ning PRVs ac­tu­al­ly per­formed some of the clin­i­cal work to bring the trop­i­cal dis­ease drug to mar­ket in the US, and that the drugs “were not sub­mit­ted as part of an ap­pli­ca­tion for mar­ket­ing ap­proval or li­cen­sure by a reg­u­la­to­ry au­thor­i­ty in In­dia, Brazil, Thai­land, or any coun­try that is a mem­ber of the Phar­ma­ceu­ti­cal In­spec­tion Con­ven­tion or the Phar­ma­ceu­ti­cal In­spec­tion Co­op­er­a­tion Scheme.”

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