FDA not utilizing its advisory system
Public Citizen said that 35 of 147 new molecular entities approved between 2000 and last July were preceded by advisory committee meetings. That represented a decrease from 1998 and 1999 when 40% and 52% respectively of approved NMEs were preceded by advisory committee meetings. NMEs with priority reviews were twice as likely to be preceded by an advisory committee meeting as were NMEs approved through standard review.
For the study period, the FDA did not make an oral scientific presentation at 18% (49 of 275) of drug advisory committee meetings, but there was no trend over time.