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6 th Annual Science and Standards Symposium January 16, 2013 Istanbul US Regulatory Updates

6 th Annual Science and Standards Symposium January 16, 2013 Istanbul US Regulatory Updates. Roger 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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6 th Annual Science and Standards Symposium January 16, 2013 Istanbul US Regulatory Updates

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  1. 6th Annual Science and Standards SymposiumJanuary 16, 2013IstanbulUS Regulatory Updates Roger L. Williams, M.D. CEO and Chair, Council of Experts

  2. The Washington, D.C. Area: USP and FDA

  3. Food and Drug Administration, White Oak Campus

  4. USP Homes

  5. Food and Drug Administration

  6. The Latest • Generics ‘Super’ Office • Office of Generic Drugs • Matches Office of New Drugs • Director: Dr. Greg Geba • Office of Product Quality • Brings in new drug chemists (Office of New Drug Product Quality/ONDPQ) • Brings in generic drug chemists • Brings 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

  7. FDASIA (Food and Drug Administration Safety and Innovation Act) • Signed into law July 2012 • Reauthorizes for five years user fee programs for prescription drugs and medical devices • Establishes new user fee programs for generic drugs (GDUFA) and biosimilars • Makes 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)

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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 * Small Business waiver for 1st NDA still possible Also Orphan drugs exempt from fee **BPD fee 10% and reactivation fee 20% of PDUFA NDA

  13. 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 *- FDA FR 6/14/12 notice withdrawing about 400 old ANDAs

  14. 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

  15. Continued Growth in ANDAs 2011 was another historic high

  16. DMFs Also Rapidly Growing Multiple references, often years after filing Combined, ANDAs and DMFs are approximately 10 X Plus, the NDA volume

  17. Increases in FDF Foreign Inspections

  18. Increases in Foreign API Inspections

  19. 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

  20. GDUFA Goals Letter Overview

  21. Goals Letter Overview • Scope, Assumptions, and Aspirations • Immediate Efficiency Enhancements • Metrics

  22. 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

  23. Next Steps • Congress Acted – President signed July 9, 2012 • Implementation program – devil in the details • Hiring and training staff • FR Notices and Guidance

  24. Contact Information Gordon Johnston Senior Associate Lachman Consultants Westbury, NY 11590 516-222-6222 NY Office 516-805-0379 Cell Email: G.Johnston@LachmanConsultants.com www.LachmanConsultants.com

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