3. INTRODUCTION
Prescription Drug User Fee Act (PDUFA) ,was a law passed
by the united states congress in 1992, which allowed the
food & drug administration (FDA) to collect fees from drug
manufacturers to fund the new drug approval process
The Act provided that the FDA was entitled to collect a
substantial application fee from dug manufacturers at the
time a new drug application (NDA) was submitted, with
those funds designated for use only in Center For Drug
Evaluation & Research (CDER)or Center For Biologics
Evaluation & Research(CBER) drug approval activities.
4. PDUFA LEGISLATION &
BACKGROUND
PDUFA must be reauthorized every 5 years &was
renewed in
1997 (PDUFA 2nd)
2002(PDUFA 3rd)
2007(PDUFA 4th)&
2012 (PDUFA 5th)
On july 9,2012 the president signed into law the food &
drug administration safety & innovation act (FDASIA),
PDUFA will provide for the continued timely review of
new drug & biologic licence application.
5. PDUFA 1st 1992
PDUFA was passed in order to shorten the length of
time from a manufacturer’s submission of NDA or
Biologics licence application to an FDA decision.
These include application review fees paid by the
sponsor for each drug or biological application
submitted .
Establishment fee paid by manufacturer annually for
each of its facilities, &product fees paid annually for
each product on the market covered by PDUFA.
6. PDUFA 2ND 1997
In 1997 reauthorized of PDUFA , congress enticted
stricter performance goals, required increased
transparency in the drug review process &tried to
facilitate better communication b/w drug makers &
patient advocacy groups.
Congress expanded the scope of the legislation to
include the investigation phase of a new drug’s
development.
7. PDUFA 3RD 2002
Part of public health & bioterrorism preparedness
Act, made appropriation for increased post marketing
of new drug & allowed the FDA to review new drug.
Drug the period that PDUFA 3rd was in effect the FDA’s
requirement that drug companies pay user fees for 50
5(b)(2) application to switch drugs from requiring a
prescription to being sold over the counter become a
source of controversy.
8. PDUFA 4TH 2007
The FDA requested & received fee increases to cover
increased reviewer workload & EXPANDED POST
MARKETING SAFETY INITIATIVES, as well as
authority to apply user fees to the monitoring of direct
of consumer drug advertising.
9. PDUFA 5TH 2012
The pharmaceutical research & manufacturers of
America (Ph RMA) strongly supports reauthorization
of PDUFA .
PDUFA can play a critical role in making more life
saving medicines available to patient in a timely
manner strengthening the scientific base of the FDA.
10. PDUFA 1992
PDUFA required drug sponsors to pay a one time fee
for a new drug application (NDA) 0r a Biological
licensing application (BLA) with clinical data.
NDA/BLA are assigned a standard or priority status at
the time of NDA submission, depending on the agent
& potential therapeutic benefits.
Under PDUFA, FDA is expected to deliver a complete
review of 90% of priority application within 6 months.
Correspondingly ,the FDA is expected to review 90%
of standard application within 12 months.
11. In particular, on or before the action
date mandatory by PDUFA ,the FDA is
expected to issue one of three outcome
letters-
the NDA is approvable, or
not -approvable
12. In case of an approved letter;
The company has right to market the drug .
For an approvable outcome, the NDA/BLA can be
approved if certain deficiencies & issues are
appropriately addressed.
In case not-approvable letter;
The company has not satisfied the FDA’s standard
of safety & efficacy with the evidence submitted in
its NDA/BLA,
13. GOALS OF PDUFA
To review of original new human drug & biological
application.
Resubmissions of original application.
Provide supplements to approved application.
Improve communication & to sets goals for specific
kinds of meetings b/w the FDA & drug sponsors.
14. FDA REVIEW PROCESS & SAFETY
Under PDUFA could operate to increase or decrease
drug risk.
PDUFA has caused FDA review to undertake more
risks in order to meet performance targets.
PDUFA also produced a large infusion of new
resources to evaluate a drugs benefits &risks in a
timely manner.
