Carticel panel's struggle with divergence
WASHINGTON - Members of the Medical Devices Advisory Committee's Orthopedic and Rehabilitation Devices Panel, FDA officials and Genzyme Tissue Repair Division were treading new ground at last week's meeting on the Carticel cartilage cell culture service, navigating a labyrinth of new FDA regulations with a new compass.
Usually, advisory panels set their course by aiming for the regulatory equivalent of the polar star: statistically significant, reproduced, double-blind, placebo controlled studies of a therapy that show a meaningful clinical benefit. Any time a company and/or FDA depart from this standard, for example in considering applications for accelerated approval of AIDS drugs, some confusion and controversy are likely to occur
There was plenty of divergence from the norm at