FDA looks to strength­en ex­pand­ed ac­cess pro­gram

The FDA on Thurs­day un­veiled plans to fur­ther strength­en its ex­pand­ed ac­cess pro­gram, as the con­tro­ver­sial Right to Try leg­is­la­tion has yet to help any pa­tients.

The ex­pand­ed ac­cess pro­gram al­lows pa­tients with se­ri­ous or im­me­di­ate­ly life-threat­en­ing dis­eases who are un­able to par­tic­i­pate in clin­i­cal tri­als to gain ac­cess to promis­ing in­ves­ti­ga­tion­al treat­ments.

Over the last five years, the FDA has au­tho­rized more than 9,000 ap­pli­ca­tions across drugs, bi­o­log­ics and de­vices through the agency’s ex­pand­ed ac­cess pro­gram, and the agency ex­pects about 800 more in­di­vid­ual re­quests next year. About 99% of all the re­quests the FDA has re­ceived, across all ap­pli­ca­tion types, have been grant­ed, though those re­quests are grant­ed af­ter the com­pa­ny of­fer­ing the treat­ment al­so signs off on the re­quest.

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