Thou­sands of gene and cell ther­a­pies are in­un­dat­ing FDA re­view­ers as the agency tries to keep up

The FDA’s staff is flood­ed with thou­sands of cell and gene ther­a­py tri­als mak­ing their way through a short-hand­ed reg­u­la­to­ry work­force.

While the FDA has plans to add to its ranks of re­view­ers, it could take years be­fore its ca­pa­bil­i­ties catch up to the biotech in­dus­try’s pipeline. There are more than 2,500 cell and gene ther­a­py tri­als un­der­way, with the bulk of those added from 2016 to 2020, ac­cord­ing to FDA of­fi­cials. The huge num­ber of pro­grams, com­bined with an un­der­staffed agency, are like­ly to re­sult in de­lays in the re­view of tri­als and ap­pli­ca­tions, more cau­tion and clin­i­cal holds from the agency, and in some cas­es more time need­ed for suc­cess­ful treat­ments to reach pa­tients.

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