Cavaz­zoni in the hot seat: House com­mit­tee grills CDER di­rec­tor on neu­ro drugs

CDER Di­rec­tor Pa­trizia Cavaz­zoni may be new to her po­si­tion, but the House En­er­gy & Com­merce Com­mit­tee isn’t us­ing kid gloves when grilling her on the FDA’s work on neu­rode­gen­er­a­tive dis­ease treat­ments.

Rep­re­sen­ta­tives fo­cused their ques­tions on the slow speed with which Cavaz­zoni and the FDA have tak­en ac­tion on some new neu­ro drugs and why some with few to no treat­ment op­tions can­not ac­cess cer­tain ex­per­i­men­tal drugs. Cavaz­zoni de­fend­ed the agency’s work in this space, point­ing to its flex­i­bil­i­ty, and not­ing that the re­cent, con­tro­ver­sial and ac­cel­er­at­ed ap­proval of Bio­gen’s Alzheimer’s drug Aduhelm is an ex­am­ple of the agency lever­ag­ing its ex­pe­dit­ed path­ways more broad­ly in neu­rode­gen­er­a­tive dis­eases.

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