After Heparin: - The Pew Charitable Trusts

More documents

Recommendations

Info

Table of Contents Executive Summary............................................................................................................ 7 Methodology.................................................................................................................... 11 Introduction and Background........................................................................................... 13 Sidebar 1: Components of a drug product............................................................16 Case Study 1: Adulteration of heparin...................................................................16 Chapter 1: Pharmaceutical Manufacturing: Globalization and Quality Management....... 21 1.1 Overview..........................................................................................................................21 1.2 Globalization of manufacturing........................................................................................21 1.2.1 Movement of U.S. drug manufacturing overseas....................................................21 Focus: China..........................................................................................................24 Focus: India...........................................................................................................24 1.2.2 Globalization of medical device manufacturing......................................................26 1.3 Gaps in ensuring quality and safety overseas..................................................................26 1.3.1 Manufacturing quality and regulation in India and China.......................................26 Case study 2: Whistle-blower alert: Ranbaxy Laboratories Limited.......................28 1.3.2 Drug ingredient quality issues resulting from deceptive practices.........................29 Case study 3: Gentamicin and Flavine International: false labeling conceals unapproved manufacturing plants..........................................................31 Case study 4: Biochimica Opos: antibiotic ingredients sourced from undisclosed suppliers.............................................................................................32 Case study 5: Lethal cough syrup in Panama........................................................33
TABLE OF CONTENTS 1.4 Problems with domestic controls on supply chain and quality........................................34 1.4.1 Insufficiencies in supplier management..................................................................34 Sidebar 2: Ensuring quality: good manufacturing practices..................................36 1.4.2 Manufacturing quality issues in the United States..................................................37 1.4.3 Challenges involved in testing................................................................................39 1.5 <strong>Pew</strong> conference and policy recommendations................................................................40 Chapter 2: Barriers to FDA Oversight.............................................................................. 45 2.1 Overview..........................................................................................................................45 2.2 Insufficient scrutiny of overseas manufacturing................................................................46 2.2.1 Foreign and domestic inspection disparities..........................................................46 2.2.2 Over-the-counter products receive less scrutiny.....................................................49 2.3 FDA capacity and information systems............................................................................49 2.3.1 FDA’s inspection staff..............................................................................................49 2.3.2 Limitations of tracking systems and data management..........................................50 2.3.3 Border assessments and importer oversight...........................................................51 2.4 FDA enforcement.............................................................................................................52 2.4.1 Limitations of current enforcement tools and authorities.......................................52 2.4.2 Legal accountability of responsible individuals at companies................................53 2.4.3 Increased information flow to FDA needed............................................................54 2.4.4 Harmonization of international standards and inspections.....................................55 2.5 <strong>Pew</strong> conference and policy recommendations................................................................56 Chapter 3: Pharmaceutical Distribution............................................................................ 63 3.1 Overview..........................................................................................................................63 3.2 Drug diversion and counterfeit drugs in U.S. distribution................................................64 3.2.1 Diversion, counterfeiting and theft are ongoing problems in the United States...........................................................................................................64
Page 1: After Heparin: Protecting Consumers
Page 5 and 6: Executive Summary In late 2007, U.S
Page 7 and 8: Executive Summary eventually being
Page 9 and 10: Introduction and Background U.S. ph
Page 11 and 12: INTRODUCTION AND BACKGROUND less ri
Page 13 and 14: 50 0 INTRODUCTION AND BACKGROUND un
Page 15 and 16: INTRODUCTION AND BACKGROUND in Chin
Page 17 and 18: CHAPTER1 PHARMACEUTICAL MANUFACTURI
Page 19 and 20: PHARMACEUTICAL MANUFACTURING: GLOBA
Page 41 and 42: 500000000 0 —Chapter 2— Figure
Page 43 and 44: —Chapter 2— FDA inspected only
Page 45 and 46: —Chapter 2— foreign offices hav
Page 47 and 48: —Chapter 2— plants. However, th
Page 49 and 50: —Chapter 2— Revived use of the
Page 51 and 52: —Chapter 2— 2.5 Pew conference
Page 53 and 54:
—Chapter 2— 2. Use comprehensiv
Page 55 and 56:
—Chapter 2— 3. Allow the FDA to
Page 57 and 58:
CHAPTER3 PHARMACEUTICAL DISTRIBUTIO
Page 59 and 60:
PHARMACEUTICAL DISTRIBUTION As dist
Page 61 and 62:
PHARMACEUTICAL DISTRIBUTION Case st
Page 63 and 64:
PHARMACEUTICAL DISTRIBUTION Sidebar
Page 65 and 66:
PHARMACEUTICAL DISTRIBUTION which i
Page 67 and 68:
PHARMACEUTICAL DISTRIBUTION the age
Page 69 and 70:
PHARMACEUTICAL DISTRIBUTION 3.4 Pew
Page 71 and 72:
PHARMACEUTICAL DISTRIBUTION d. If t
Page 73 and 74:
REFERENCES 16 Fagan, Kevin. Testimo
Page 75 and 76:
REFERENCES 58 Schwartzkopff, France
Page 77 and 78:
REFERENCES 111 NSD Bio Group. “Po
Page 79 and 80:
REFERENCES 155 State Food and Drug
Page 81 and 82:
REFERENCES 195 U.S. Food and Drug A
Page 83 and 84:
Page 85 and 86:
Page 87 and 88:
REFERENCES 332 Public Law 111-8—M
Page 89 and 90:
REFERENCES 378 Villax, Guy. Board M
Page 91 and 92:
REFERENCES 429 U.S. Supreme Court,
Page 93 and 94:
REFERENCES 479 Michelle M. Ciolek,
Page 95 and 96:
REFERENCES 521 21 USC §828 (a). 52
Page 97 and 98:
APPENDIX A Expert Interviews Bill A
Page 99 and 100:
APPENDIX B Pew Stakeholder Conferen
Page 101 and 102:
APPENDIX C Pew Stakeholder Conferen
Page 103 and 104:
Pew Stakeholder Conference Agenda T
Page 105 and 106:
acknowledgments We gratefully ackno
show all

After Heparin: - The Pew Charitable Trusts

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?