6 th annual science and standards symposium january 16, 2013 istanbul us regulatory updates roger l....
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6th Annual Science and Standards SymposiumJanuary 16, 2013Istanbul
US Regulatory UpdatesRoger L. Williams, M.D.CEO and Chair, Council of Experts
The Washington, D.C. Area: USP and FDA
Food and Drug Administration, White Oak Campus
USP Homes
Food and Drug Administration
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The Latest
Generics ‘Super’ OfficeOffice of Generic DrugsMatches Office of New DrugsDirector: Dr. Greg GebaOffice of Product QualityBrings in new drug chemists (Office of New Drug Product Quality/ONDPQ)Brings in generic drug chemistsBrings in Office of Manufacturing and Product Quality (formerly with Office of Compliance)Review of CMC for new drugs, generic drugs and post-approval changes, together with inspection component
Signed into law July 2012Reauthorizes for five years user fee programs for
prescription drugs and medical devicesEstablishes new user fee programs for generic drugs
(GDUFA) and biosimilarsMakes further FDA reforms (in line with FDA global strategy)
–Emphasizes risk-based approach, foreign inspections (FDA will perform reviews and audits of foreign drug safety programs and standards), greater manufacturer accountability (know your supplier, testing–manage risk/establish safety of raw materials and finished drugs)
–Drug supply chain improvements (but no track and trace- possibly to be in a future bill)
–Drug shortages (manufacturer notification)
FDASIA (Food and Drug Administration Safety and Innovation Act)
GDUFA
S.3187 – “Food and Drug Administration Safety and Innovation Act” (FDASIA)
GDUFA is Section 301 of FDASIA Bipartisan effort – hardly see these days Fast approval – moved quickly thru House and Senate Reconciliation process rapid Signed by the President on July 9, 2012
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What’s New at the Office of Generic Drugs/Review Times
New ANDA Requirements– 3 batch requirements for ICH Stability conditions– 3 batch requirements coming for all ANDAs– Size, shape, color issues – Tightening ANDA filing requirements
• Monitor Completeness and Acceptability Checklist
Staff time re: GDUFA implementation– Daunting task – lots of meeting, training new employees
– takes staff and management away from review time
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Other Impacts of GDUFA on OGD Program
Coordination of inspections with Office of Compliance Complete response letter coordination New review practices…reorganization of CMC reviewers? Integrating New Drugs into the GDUFA program
– Consults – labeling carve out, toxicology, etc.– Office of Chief Counsel and Office of Reg Policy
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How Does OGD Get to 2015-2017 Metrics?
Last twelve months– Average receipts of originals 92/month (1103)– Average approvals 43 AP/month (479)
Backlog at OGD is at 2933* ANDAs as of 9/30/2012– To clear backlog at current rate – 2933/517 = 5.67years– If stream of ANDA continue at current pace (1000+/yr) and
with the phase in of staffing over 3 years there will be great pressure to meet the 3-5 year metrics
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User Fee Issues
New User Fees for FY 2013 (PDUFA) (BsUFA)**– Remember Fees for all (b)(2) applications*– Modestly higher fees Only 6.3% – New fees
• NDA with clinical data• $1,958,803
• NDA without clinical data• $979,600
• Establishment fees (+1.2%)• $526,500
• Product fees (actual decrease -0.6%)• $98,380
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* Small Business waiver for 1st NDA still possible Also Orphan drugs exempt from fee**BPD fee 10% and reactivation fee 20% of PDUFA NDA
Generic Drug User Fee “Guesstimate”
GDUFA Fees (estimate based on $299 million)– US Establishment $110-125,000– X US Estab. $125-140,000– US API Estab. $ 18 - 25,000– X US API Estab. $ 30 - 40,000– Orig. ANDA $ 51,520– PAS $ 25,760– Orig. DMF $ 21,340– ANDA Backlog Fee $ 17,434
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*- FDA FR 6/14/12 notice withdrawing about 400 old ANDAs
Generics Success Represents Unprecedented 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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AN
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2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
2011 was another historic high
Continued Growth in ANDAs
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Combined, ANDAs and DMFs are approximately 10 X Plus, the NDA volume
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Typ
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MF
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2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
Multiple references, often years after filing
DMFs Also Rapidly Growing
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Increases in FDF Foreign Inspections
Original EER's by location - FDF profile group
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100
200
300
400
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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
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200
400
600
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1000
1200
2001 2002 2003 2004 2005 2006 2007 2008 2009
ANDA Domestic
ANDA Foreign
NDA Domestic
NDA Foreign
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GDUFA Addresses Those Challenges
$299M per year is less than ½ of 1% of Generic Drug sales• And is expected to reduce costs considering the reduced
development/regulatory timelines
GDUFA results in less than doubling in OGD over the life of the program
• Efficiency enhancement are a critical component of GDUFA
GDUFA is modest size despite 10 X plus the application volume of brands
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GDUFA Goals Letter
Overview
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Goals Letter Overview
Scope, Assumptions, and Aspirations
Immediate Efficiency Enhancements
Metrics
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Key Achievements
The program advances critical values
• Timely access to generic drugs• Certainty for industry and FDA
• Safe, high quality generic drugs
• Maintains affordability of generic drugs
• Increases Transparency
• Addresses Globalization
• Advances Regulatory Science
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Next Steps
Congress Acted – President signed July 9, 2012
Implementation program – devil in the details
Hiring and training staff
FR Notices and Guidance
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Contact Information
Gordon JohnstonSenior Associate
Lachman ConsultantsWestbury, NY 11590
516-222-6222 NY Office516-805-0379 Cell
Email: [email protected]
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