Download Impact of Prescription Drug User Fee Program Overall

Impact
of Prescription
Drug User Fee Program
Janet Woodcock,
M.D.
Director, Center for Drug
Evaluation
and Research
September
IS,2000
Overall
Assessment
Program has been successful
achieving
its original
goals:
l
l
l
in
Eliminate
backlogs
Decrease review times
Shorten time to approval
3
. --
PDWFA Benefits:
access
Public
l
Faster
to new therapies
l
Increased
industry incentive
to
invest in new therapeutic
areas
.
l
Greater
l
Improved
openness
of the process
drug development
,
PDUFA
l
Benefits:
Regulation
Improved
l
l
l
resources
More reviewers,
pm-approval
computer statt
Upgraded Infrastructure
Highly-skilled
new staff
l
Better
industry
l
Streamlined
PDUFA
l
l
I
FDA Drug
Greater
Access
input
inspectors,
applications
processes
Benefits:
openness
to Agency
advice
&
--.
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I
Challenges
l
Covers limited part of drug life cycle
premarket
review - does not support:
l
l
l
_.
-..e
.-
I
-
Drug safety surveillance
after approval
Drug advertising
regulation
.
GMP surveillance
l Limits
l
of PDUFA
,
Tracking
FDA flexibility
subsidiary
to manage resources
goals is burdensome
.
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