Up­dat­ed: FDA pulls paid Ei­sai con­sul­tant from tem­po­rary role on ad­comm re­view­ing Ei­sai's new Alzheimer's drug

The FDA’s ad­vi­so­ry com­mit­tees of out­side ex­perts are sup­posed to of­fer the agency with un­bi­ased re­views of the spon­sor’s ef­fi­ca­cy and safe­ty da­ta be­fore them. And while oc­ca­sion­al­ly the FDA will al­low cer­tain tan­gen­tial­ly paid con­sul­tants (e.g. from a com­pet­ing firm), those re­la­tion­ships must be dis­closed ahead of time, and waivers from that COI need to be grant­ed.

In the case of David Weis­man, a neu­rol­o­gist with Penn­syl­va­nia-based Abing­ton Neu­ro­log­i­cal As­so­ciates who worked on clin­i­cal tri­als for Ei­sai and Bio­gen, the FDA had sought his ex­per­tise in Fri­day’s ad­comm that will dis­cuss whether to con­vert Ei­sai’s new Alzheimer’s drug Leqem­bi (lecanemab) in­to a full ap­proval. The de­ci­sion is like­ly to be one in fa­vor of Leqem­bi, open­ing the door for wider sales na­tion­wide with CMS cov­er­age.

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