New JA­MA study digs in­to the rise of stack­ing FDA’s ex­pe­dit­ed pro­grams and des­ig­na­tions for new drugs

The num­ber of phar­ma spon­sors tak­ing ad­van­tage of the FDA’s ex­pe­dit­ed pro­grams has sky­rock­et­ed in re­cent years, in­clud­ing the use of mul­ti­ple des­ig­na­tions to hur­ry a new com­pound along. Those in­creas­es are on­ly ex­pect­ed to con­tin­ue, ac­cord­ing to FDA-au­thored re­search pub­lished in JA­MA on Tues­day.

Over the last three decades, the num­ber of new drugs re­ceiv­ing an or­phan drug des­ig­na­tion in­creased four-fold, and more than 90% of new on­col­o­gy drugs used one of the agency’s ex­pe­dit­ed pro­grams since 2008.

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