Clinical Trial Results
PDUFA Dates and Black Box Warnings
Like the FDA needs more bad press. The beleaguered drug watchdog
has taken hits aplenty over the last few years for more reason that can
be counted. The etiology of which, stem mostly from the lack of
sufficient funding from congress and an increasing workload. A study
published today in the NEJM illustrates what happens when you approve
drugs on a deadline instead of on merit.
The study by Daniel Carpenter, Ph.D., Evan James Zucker, B.A., and Jerry Avorn, M.D.
shows that drugs approved in the last 2 months approaching the PDUFA
date, compared to all other approvals from 1993-2004 were 5.5 times as
likely to have a saftey-related withdrawral, 4.4 times as likely to
have a black box warning and 3.3 times as likely to have at least one
dosage-form discontinued.
These numbers are both telling and shocking. The FDA has released a
note saying the numbers used in the study do not match their internal
stats however, with news this last week that the FDA was granted
authority to start missing PDUFA deadlines, at least unofficially, they
seem to have noticed the same trend.
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