Cor­nered by crit­ics, top FDA of­fi­cials stand by Aduhelm OK amid calls to re­form ac­cel­er­at­ed ap­proval process

Bio­gen’s Aduhelm has trig­gered a fresh round of de­bate be­tween the FDA, pub­lic health ex­perts and doc­tors on the pages of a pres­ti­gious med­ical jour­nal, crys­tal­liz­ing the key ar­eas of a di­vide that will like­ly have last­ing im­pli­ca­tions for the fu­ture reg­u­la­to­ry land­scape.

None of the ar­gu­ments are ex­act­ly new. As JA­MA ed­i­tor-at-large Robert Stein­brook wrote in an ac­com­pa­ny­ing note to the trio of view­points, “The ap­proval of ad­u­canum­ab is one of the most con­se­quen­tial and crit­i­cized de­ci­sions the FDA has made in years.” But while the au­thors have made sim­i­lar points in a va­ri­ety of set­tings, the col­lec­tion rep­re­sents the first time they’ve been pre­sent­ed to­geth­er — and re­flects, in par­tic­u­lar, what FDA reg­u­la­tors con­sid­er their strongest de­fense for their con­tro­ver­sial ap­proval.

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