INDEX Introduction PDUFA legislation & background Goals of PDUFA FDA review process & drug safety.
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.
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.
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.
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.
PDUFA 3RD 2002Part 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.
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.
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.
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.
In particular, on or before the actiondate mandatory by PDUFA ,the FDA isexpected to issue one of three outcomeletters-the NDA is approvable, ornot -approvable
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,
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.
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.