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CHIR Best Brains Exchange 22 January 2016

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Quality of drugs manufactured in emerging economies: Are cost containment strategies heightening the likelihood of substandard drugs in Canada?

What regulatory, policy, and/ or governance changes are needed to address new and increased risks?
How can Canada prevent and reduce health risks that emerge when the pharmaceutical industry adopts globalized production strategies?

Published in: Government & Nonprofit
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CHIR Best Brains Exchange 22 January 2016

  1. 1. Quality of drugs manufactured in emerging economies: Are cost containment strategies heightening the likelihood of substandard drugs in Canada? CIHR BEST BRAINS EXCHANGE FRIDAY, JANUARY 22, 2016. CIHR’S OFFICES 160 ELGIN STREET, 9TH FLOOR OTTAWA, ON Ajaz S. Hussain, Ph.D. @ CIHR Best Brains Exchange, Ottawa, ON, January 22, 2016 1
  2. 2. Key Questions What regulatory, policy, and/ or governance changes are needed to address new and increased risks? How can Canada prevent and reduce health risks that emerge when the pharmaceutical industry adopts globalized production strategies? Ajaz S. Hussain, Ph.D. @ CIHR Best Brains Exchange, Ottawa, ON, January 22, 2016 2
  3. 3. Speakers & Assigned Topics • Scene Setting Presentation – Challenge of substandard drugs for public health Mark Paxton, Chief Executive Officer, Rx-360 • Tension between the affordability and the access to drugs that emerges due to cost containment strategies Suzanne McGurn, Assistant Deputy Minister and Executive Officer, Ontario Public Drug Programs Ontario Ministry of Health and Long-Term Care • What is driving globalized production strategies in the pharmaceutical industry? Ajaz S. Hussain, Executive Director, The National Institute for Pharmaceutical Technology and Education • Potential risk factors that emerge, or are increased, when drug production is performed in emerging economies Andy Stergachis, Director, Global Medicines Program, School of Public Health, University of Washington Ajaz S. Hussain, Ph.D. @ CIHR Best Brains Exchange, Ottawa, ON, January 22, 2016 3
  4. 4. What is driving globalized production strategies in the pharmaceutical industry? AJAZ S. HUSSAIN, EXECUTIVE DIRECTOR, THE NATIONAL INSTITUTE FOR PHARMACEUTICAL TECHNOLOGY AND EDUCATION AJAZ@NIPTE.ORG Ajaz S. Hussain, Ph.D. @ CIHR Best Brains Exchange, Ottawa, ON, January 22, 2016 4
  5. 5. Manufacturing in Emerging Economies for Canada, USA, …:‘Better than Placebo’ “Rest bring data” Application: NDA,.., ANDA “Scale-up & Process Validation” CGMP Compliance, “Certification” Ajaz S. Hussain, Ph.D. @ CIHR Best Brains Exchange, Ottawa, ON, January 22, 2016 5
  6. 6. Globalization Drivers? Manufacturing in Emerging Economies for Canada, USA,..: Ajaz S. Hussain, Ph.D. @ CIHR Best Brains Exchange, Ottawa, ON, January 22, 2016 6 COGS Direct Materials Beginning Inventory 0 Purchases 9,000 Direct Materials Available 9,000 Ending Direct Materials Inventory (4,000) Direct Materials Used 5,000 Direct Labor 2,000 Factory Overhead 1,100 Total Manufacturing Cost 8,100 Add: Beginning Work-in-Process Inventory 5,000 Total Manufacturing Cost to Account For 13,100 Less: Ending Work-in-Process Inventory 4,500 Cost of Goods Manufactured 8,600 At a lower costs for development & manufacturing Capability to satisfy regulatory requirements in Canada, US,,..
  7. 7. Globalization of costs & not accounting for differences in quality understanding Served as a ‘stress test’ for the regulatory systems in Canada, USA,… Exposed prevailing intra- and inter-agency heterogeneity and capacity constraints Eroded public’s confidence in quality; palpable increase in nocebo effects Reminded us that complexity and uncertainty remains underappreciated Design, Controls, Specifications CGMP Compliance QMS & assurance of data integrity Review & Inspection Ajaz S. Hussain, Ph.D. @ CIHR Best Brains Exchange, Ottawa, ON, January 22, 2016 7
  8. 8. “…..When the drug safety system fails, people get sick. Some die. It is hard to detect harm. Some of these people are already very vulnerable… and proving the cause of harm from impurities, adulteration, and counterfeits can be elusive. FDA inspectors look for a culture of quality at manufacturing facilities. Certainly the companies are obligated to ensure a culture of quality and maintain vigilance as well. This reflects a systems approach to safety. This system approach wasn't at play here….” Ajaz S. Hussain, Ph.D. @ CIHR Best Brains Exchange, Ottawa, ON, January 22, 2016 8 http://www.spokesman.com/stories/2008/apr/23/house- panel-criticizes-fda-on-foreign-inspections/ Congressman Shimkus
  9. 9. Breaches in assurance of data integrity is a Global Issue! •Probe Finds Kaketsuken’s GMP Violations “Extremely Malicious”, MHLW to Impose Penalty(3 Dec. 2015) Mr. Shiozaki, Head of MHLW regrets they could not find GMP violation (Dec 8, 2015) PMDA says Routine GMP Inspection to be done without prior notice ….8 Dec 2015 Einstein’s challenge…. we will never solve the problems tomorrow with the same order of consciousness we are using to create the problems of today! Ajaz S. Hussain, Ph.D. @ CIHR Best Brains Exchange, Ottawa, ON, January 22, 2016 9 http://pj.jiho.jp/servlet/pjh/regulatory/outline/1226583374392.html
  10. 10. Use of foreign-sourced materials creates vulnerabilities in the U.S. drug supply. …FDA has been working for over a decade to stimulate modernization QbD … an opportunity to reduce manufacturing costs while ensuring that consumers receive high- quality drug products…. with the proper strategies, revitalize pharmaceutical manufacturing in the United States. Ajaz S. Hussain, Ph.D. @ CIHR Best Brains Exchange, Ottawa, ON, January 22, 2016 10 http://www.pharmaceuticalonline.com/doc/cder-s-janet-woodcock- nobody-can-really-tell-me-if-fda-inspections-are-effective-0001 and http://www.fda.gov/NewsEvents/Testimony/ucm378343.htm
  11. 11. FDA/CDER/OPQ = “Integrated” How did we get here? Pre-OPS to OPS to OPQ Assuring Same Quality Standards to Safeguard Clinical Performance Enhancing Science- and Risk-based Regulatory Approaches Transforming Qualitative- Quantitative and Expertise-based Product Quality Informatics Quality Metrics Question-based Review New Inspection Protocol Integration of Review, Inspection, Surveillance, Policy, and Research Team-based Integrated Quality Assessment (IQA) Program Alignment across FDA Encouraging Development of Emerging Technology Quality Information BLAs/NDAs/ANDA how does it link to patients? Ajaz S. Hussain, Ph.D. @ CIHR Best Brains Exchange, Ottawa, ON, January 22, 2016 11 CDER Office of Pharmaceutical Quality
  12. 12. Immediate policy considerations: Appreciate complexity and uncertainty • Regulatory review – ask the right questions • An harmonized, integrated (review-inspection), life-cycle approach to analytical & process ‘validation’ • Product risk-assessment criteria when deviations from CGMPs occur • Quality metrics – supply chain reliability; distinguish between malicious and misguided behaviors • Focus on quality system & systems thinking – recognize the difference between complicated vs complex Risk-assessment & classification Quality Metrics Culture of Quality Ajaz S. Hussain, Ph.D. @ CIHR Best Brains Exchange, Ottawa, ON, January 22, 2016 12
  13. 13. Invest in Pharmaceutical Technology Research & Education The Nation Needs a Comprehensive Pharmaceutical Engineering Education and Research System. Ajaz S. Hussain. Pharmaceutical Technology. September 2005 Ajaz S. Hussain, Ph.D. @ CIHR Best Brains Exchange, Ottawa, ON, January 22, 2016 13
  14. 14. Summary Capability to satisfy regulatory requirements in Canada, US,…, at a lower development & manufacturing costs. Key drivers: EBITDA Exposed prevailing intra- and inter-agency heterogeneity and capacity constraints Globalization of costs Complexity and uncertainty in the assurance of ‘pharmaceutical quality’remains underappreciated Non- compliance: Global Issue Product risk-assessment criteria & Quality metrics – for supply chain reliability; distinguish between malicious and misguided behaviors Immediate policy considerations Catch-up with the paradigm long-shifted: “compounding” to “manufacturing”; “compendia” to “statistical confidence” Invest in Research & Education Manufacturing in Emerging Economies for Canada, USA,.. Ajaz S. Hussain, Ph.D. @ CIHR Best Brains Exchange, Ottawa, ON, January 22, 2016 14

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