After Heparin: - The Pew Charitable Trusts

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TABLE OF CONTENTS Case study 6: Medicaid drugs purchased on the streets and resold into distribution......................................................................................................65 Case study 7: A counterfeit injectable drug eludes tracking.................................67 3.2.2 Risks originating outside the United States............................................................68 Sidebar 3: Parallel importation, re-importation and personal importation............69 3.3 Barriers to drug tracking and oversight of distribution....................................................70 3.3.1 Limits of current tracking requirements ..................................................................70 Sidebar 4: Regulation of controlled substances by the U.S. Drug Enforcement Administration..................................................................................71 3.3.2 The Prescription Drug Marketing Act .....................................................................72 3.3.3 Electronic tracking system proposals......................................................................73 Sidebar 5: What is “track-and-trace”?...................................................................74 3.4 Pew conference and policy recommendations................................................................75 References........................................................................................................................ 79 Appendix A: Expert interviews....................................................................................... 105 Appendix B: Pew stakeholder conference roundtable participants................................ 107 Appendix C: Pew stakeholder conference agenda......................................................... 109 Appendix D: List of acronyms......................................................................................... 113 Acknowledgments.......................................................................................................... 115
Executive Summary In late 2007, U.S. health officials began receiving reports of unexpected allergic-type reactions in patients undergoing dialysis. 1 The reactions were linked to a widely used blood thinner—heparin 2 —and specifically to an adulterant that had been introduced during manufacture of the drug in China. 3–5 The U.S. Food and Drug Administration (FDA) believes the adulteration of heparin was an economically motivated act—a clear breach of the U.S. pharmaceutical supply chain. 6 Pharmaceutical manufacturers and distributors work together in a robust system to deliver high-quality products, but drug manufacturing and distribution have become increasingly complex in recent years. Prescription and over-the-counter (OTC) medications originate in factories all over the world, moving into the American marketplace through supply chains that can involve numerous processing plants, manufacturers, suppliers, brokers, packagers and distributors. The number of drug products made outside of the United States doubled from 2001 to 2008, according to FDA estimates. 7 The FDA estimates that up to 40 percent of finished drugs used by U.S. patients is manufactured abroad, 8,9 and 80 percent of active ingredients and bulk chemicals used in U.S. drugs comes from foreign countries. 10 Increasingly, the United States relies on drug manufacturing in developing countries—mainly China and India. Globalization, increased outsourcing of manufacturing, the complexity of pharmaceutical distribution and the existence of criminal actors willing to capitalize on supply chain weaknesses has created the potential for counterfeit or substandard medicines to enter the system and reach patients. As evidenced by the adulteration of heparin and other case studies outlined in this report, these rare but potentially serious events can have grave consequences. For economic reasons, the movement of manufacturing from the United States to foreign countries is likely to continue. However, industry and regulatory bodies have failed to adapt adequately to these changing circumstances. Drawing on public documents, peer-reviewed publications and dozens of interviews with industry stakeholders, regulators and supply chain experts, this Pew Health Group white paper provides an overview of the complex, modern pharmaceutical supply chain and its risks from manufacturing through distribution of the finished drug. A discussion draft of this document was developed to inform a Pew Health Group stakeholder conference on ensuring the safety of the U.S. drug supply that was held on March 14 After Heparin: PRotecting Consumers from the Risks of Substandard and Counterfeit Drugs 7
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REFERENCES 16 Fagan, Kevin. Testimo
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REFERENCES 58 Schwartzkopff, France
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REFERENCES 111 NSD Bio Group. “Po
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REFERENCES 155 State Food and Drug
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REFERENCES 195 U.S. Food and Drug A
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REFERENCES 332 Public Law 111-8—M
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REFERENCES 378 Villax, Guy. Board M
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REFERENCES 429 U.S. Supreme Court,
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REFERENCES 479 Michelle M. Ciolek,
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REFERENCES 521 21 USC §828 (a). 52
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APPENDIX A Expert Interviews Bill A
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APPENDIX B Pew Stakeholder Conferen
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APPENDIX C Pew Stakeholder Conferen
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Pew Stakeholder Conference Agenda T
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acknowledgments We gratefully ackno
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After Heparin: - The Pew Charitable Trusts

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