generic drugs user fee
DESCRIPTION
FDA presentation on Generic drug user fees uploaded for benefit of all.TRANSCRIPT
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Agenda
• Process and Access
• Challenges and Success of Generics
• Outlines of the Act
• Legislative Language
• Goals Letter
• Next Steps
• Questions and Answers
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Process and Access
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Generic Industry Large & Fragmented
• Made up of both final dosage form (FDF) and active pharmaceutical ingredient (API) manufacturers
• Thousands of firms spread worldwide
• In virtually every continent and country
• Large and small
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Access To All Through Multiple Vehicles• Extensive outreach• FDF and API trade associations at table
– Generic Pharmaceutical Association (GPhA,) European Fine Chemicals Group (EFCG,) and the Society of Chemical Manufacturers and Affiliates’ Bulk Pharmaceuticals Task Force (SOCMA’s BPTF)
• Members worldwide– 16 all-day negotiation sessions using a highly transparent
process• Negotiation summaries on public Web site
• Open docket throughout– FDA-2010-N-0381 – Open Sept. 17, 2010 - Jan 6, 2012
• Multiple open public stakeholder meetings– 6 public meetings & stakeholder updates, starting Sept. 17, 2010
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Environment
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Generics Success = Unprecedented Regulatory Challenge• $931 billion in savings (2001-2010) has resulted in
continued success and growth
• While program funding has remained relatively flat
• Generics industry success has come to represent an unprecedented regulatory challenge in terms of– Size
– Scope
– Geography
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020
040
060
080
01,
000
AN
DA
Rec
eipt
s
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
Continued Growth in Abbreviated New Drug Applications (ANDAs)
2011 was another historic high
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Drug Master Files (DMFs) Also Rapidly Growing
Combined, ANDAs and DMFs are approximately 10X Plus the NDA volume
020
040
060
080
0
Type
II D
MF
Rec
eipt
s
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
Multiple references, often years after filing
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Growth Leads To Expanding Backlog
0
500
1000
1500
2000
2500
3000
2006 2007 2008 2009 2010 2011
Pend
ing ANDAs
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Increases in FDF Foreign Inspections
Original EER's by location - FDF profile group
0
100
200
300
400
500
600
700
2001 2002 2003 2004 2005 2006 2007 2008 2009
ANDA Domestic
ANDA Foreign
NDA Domestic
NDA Foreign
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Increases in Foreign API Inspections
Original EER's by location - API profile group
0
200
400
600
800
1000
1200
2001 2002 2003 2004 2005 2006 2007 2008 2009
ANDA Domestic
ANDA Foreign
NDA Domestic
NDA Foreign
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Focusing on Doing the Most Good
• Four walls and a roof• Limit cost
– $299 million/year is Less than ½ of 1% of generic drug sales
• Expected to reduce costs, considering the reduced development/regulatory timelines
– Less than doubling in OGD• Efficiency enhancements are a critical component of GDUFA
• Ten-month review cycle• First in, first reviewed• Eliminate the backlog• Risk-adjusted, biennial inspection, with parity of foreign and domestic
frequency
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Outline of the Act
• Legislation– Authorizes collection of user fees– Establishes type of fees– Five year timeframe
• Goals Letter– Program scope, assumptions– Efficiency enhancements
• ANDA, DMF, Inspection, Other
– Regulatory science initiatives– Metrics/Goals
• Human resources; submission review; controlled correspondence; inspections; backlog
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LegislationOverview
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Outline of the Act
• Funding level = inflation adjusted $299 million/year
• Application Fees– Applications in the backlog (year 1 only)
– Drug master file fee (and availability for reference list)
– ANDA and prior approval supplement (PAS) filing fee
• Facility Fees – Involved in manufacture of generic drugs, whether API or
Finished Dosage Form, domestic or foreign
• Individual fees calculated/published upon implementation
• Fees not linked to types of services; rather overall goals
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17
Fee Estimates: Public Stakeholder Meeting
• Estimates Only– Backlog ~ $25K
– DMF ~$40K
– ANDA ~ $60K
– Supplement ~ $30K
• for PAS only; $0 for changes being effected (CBE)
– Facility ~ $85K average
• Range estimates between $35K (API) and $150K (FDF)
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Outline of the Act
• Identification of facilities
• Effect of failure to pay fees
• Other provisions– Appropriations and spending triggers
– Streamlined hiring authority
– Definitions
– Positron emission tomography (PET) drugs
– Reauthorization
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Goals LetterOverview
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Goals Letter Overview
• Scope, assumptions, and aspirations
• Immediate efficiency enhancements
• Metrics
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Scope, Assumptions & Aspirations
• Scope limited to generics
• Assumptions impacting viability
– Streamlined hiring
– Risk-adjusted inspection
• Aspirations (primarily during hiring period)
– Maintaining productivity while hiring and training
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Goals - Immediate Efficiency (ANDA)
• Complete Response letters
• Division-level deficiency review
• Rolling review
• First cycle meetings– 200 in FY 2015
– 250 in FY 2016
– 300 in FY 2017
• Expedite Paragraph IV (Day 1 submissions)
• Review goals (except backlog) applied to electronic submissions
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Goals – Immediate Efficiency (DMFs)
• Same as ANDAs
• Initial Completeness Assessment
• Available for Reference List
• DMF Completeness Letter
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Goals – Immediate Efficiency (Inspection)
• Release inspection classification and date
• Third-party foreign regulator inspection program
evaluation– FDA will first have to determine the equivalence between a
specific foreign regulator and FDA, and can then develop formal
mechanisms to routinely accept the inspection of that foreign
government regulatory body
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Goals – Other Efficiency and Regulatory Science
• Facility, current chemistry manufacturing control (CMC)
records, and other databases
• Electronic data submission standards
• Regulatory science initiatives
– Improves access
– Post-market safety
– Issue guidance
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Metrics
• Initially focused on staff and training
• Inspection
• Review metrics and cohorts similar to Prescription Drug User Fee Act (PDUFA) - 10 month cycle
• Quality Focus Initiative– Increasing review times for poor quality or unwarranted,
unsolicited amendments
– Electronic submissions
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Metrics – Human Resources (HR)
• Hire and train 25% of incremental staff in FY 2013
• Hire and train 50% of incremental staff in FY 2014
• Strive to complete hiring and training in FY 2015
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Metrics - ANDA
• DMF and inspection subsumed
• All applications grouped in cohort year
• Original ANDA review (review and act on):– 60% of submissions within 15 months for year 3 cohort
– 75% of submissions within 15 months for year 4 cohort
– 90% of submissions within 10 months for year 5 cohort
– Expedite paragraph IV (Day 1 Submissions) submissions for year 1 and 2 cohorts
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Metrics – ANDA Amendments• Goals are incremental and additive
– Pre CR application goal date adjusted– Post CR a new goal date from date of the new submission– “Delaying” amendments do not add to amendment count
• Amendments are grouped– Tier 1 – Solicited 1st major & 1st–5th minor, unsolicited “delaying”
• Most favorable – (example: 90% first major within 10 months for year 5 cohort)
– Tier 2 – Not “delaying” unsolicited• Less favorable – (example: 90% within 12 months for year 5 cohort)
– Tier 3 – solicited major after 1st, unsolicited minor after 5th• No goals metric
– This is a quality initiative… “get it right the first time”– Interim metrics apply for all – see goals letter
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Metrics – PAS
• No Inspection Required– 60% of submissions within 6 months for FY 2015 receipts
– 75% of submissions within 6 months for FY 2016 receipts
– 90% of submissions within 6 months for FY 2017 receipts
• Inspection Required– 60% of submissions within 10 months for FY 2015 receipts
– 75% of submissions within 10 months for FY 2016 receipts
– 90% of submissions within 10 months for FY 2017 receipts
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Metrics – Other
• Controlled correspondences
• Inspection metrics– Risk-adjusted surveillance inspection
• Achieving biennial inspection rate and parity of foreign and domestic frequency in FY2017
– Pre-approval inspections (PAIs) continue
• Backlog metrics– Review and act on 90% of backlog applications pending on
Oct. 1, 2012, by end of FY 2017
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Key Achievements
• The program advances critical values – Timely access to safe, high quality, affordable generic drugs
– Increases transparency
– Addresses globalization
– Advances regulatory science
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Next Steps
• Appropriations
• Implementation