After Heparin: - The Pew Charitable Trusts

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REFERENCES 176 U.S. Food and Drug Administration. FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India. FDA News Release, September 16, 2008. http://www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/2008/ucm116949.htm. Accessed February 17, 2010. 177 U.S. Food and Drug Administration. List of Drugs Manufactured at the Dewas and Paonta Sahib Facilities of Ranbaxy Laboratories, Ltd. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/ ucm118441.htm. Accessed February 17, 2010. 178 U.S. Food and Drug Administration. FDA Takes New Regulatory Action Against Ranbaxy’s Paonta Sahib Plant in India. FDA News Release, February 25, 2009. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149532.htm. Accessed February 17, 2010. 179 U.S. Food and Drug Administration, New York District. Warning Letter (NYK: 2010-07) to Robert Patton, Vice President, General Manager, Ohm Laboratories, Inc. December 21, 2009. http://www.fda.gov/ICECI/EnforcementActions/ WarningLetters/ucm204903.htm. Accessed November 11, 2010. 180 FDA Media Briefing on Ranbaxy Labs. September 17, 2008. Moderator: Rita Chappelle. http://www.fda.gov/downloads/ NewsEvents/Newsroom/MediaTranscripts/ucm121266.pdf. Accessed August 19, 2010. 181 Bate, Roger. “Good Move on Bad Drugs: The Ranbaxy Scandal.” American Enterprise Institute for Public Policy Research. Articles and Commentary. October 3, 2008. http://www.aei.org/article/28726. Accessed August 20, 2010. 182 Srinivasan, V. Srini, Vice President, Verification Program, United States Pharmacopoeia. Direct communication, September 10, 2009. 183 U.S. Food and Drug Administration Consumer Health Information. “FDA beyond Our Borders.” http://www.fda.gov/ downloads/ForConsumers/ConsumerUpdates/ucm103044.pdf Accessed June 18, 2010. 184 U.S. Food and Drug Administration. FDA Public Health Alert: Healthcare Professionals Warned Not to Use Certain Intravenous Metronidazole, Ondansetron, and Ciprofloxacin Due to Potential Contamination. Updated June 1, 2010. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm214035.htm Accessed June 3, 2010. 185 Ibid. 186 Chambers, Rick. “Pfizer Initiates a Nationwide Voluntary Recall of All Lots of Metronidazole Injection, Ciprofloxacin Injection, and Ondansetron Injection Bags Made by Claris Lifesciences Due to Non-Sterility.” Pfizer Inc. June 3, 2010. http://www.fda.gov/Safety/Recalls/ucm214848.htm. Accessed June 11, 2010. 187 U.S. Food and Drug Administration. Warning Letter (WL: 320-11-003) to Mr. Arjun S. Handa, Chief Executive Officer & Managing Director, Claris Lifesciences Limited, Chacharwadi—Vasana. November 1, 2010. http://www.fda.gov/ICECI/ EnforcementActions/WarningLetters/ucm233010.htm. Accessed November 14, 2010. 188 U.S. Food and Drug Administration. Warning Letter (WL: 320-10-01) to Mr. Tao Chen, General Manager, XiAn Libang Pharmaceutical Co., Ltd. Shaanxi, China. January 28, 2010. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ ucm200384.htm. Accessed January 11, 2011. 189 Ibid. 190 European Commission. Annex I: Scientific Conclusions and Ground for Amendments of the Marketing Authorisation and Recall of Batches Presented by the European Medicines Agency. Annex to multiple Commission Decisions of 29.3.2010: suspending the marketing and withdrawing, under Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, certain batches of [multiple Clopidogrel products], a medicinal product for human use. http:// ec.europa.eu/health/documents/community-register/2010/2010032978389/anx_78389_en.pdf. Accessed August 25, 2010. 191 U.S. Food and Drug Administration. Memorandum to Mr. Malvinder Mohan Singh, CEO & Managing Director, Ranbaxy Laboratories Limited. February 25, 2009. 192 André, Philippe. Director, Qualiau Pharmaceutical Auditing Co., Ltd.; Associate Professor, School of Pharmaceutical Science and Technology, Tianjin University. “API Manufacturing Situation in China.” Presentation to European Fine Chemicals Group, May 13, 2009. 193 Usdin, Steve. The Heparin Story. International Journal of Risk & Safety in Medicine, Vol. 21, 2009, 99–103. 194 Parkinson, Robert L., Chief Executive Officer, Baxter International. Testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives. April 29, 2008. After Heparin: PRotecting Consumers from the Risks of Substandard and Counterfeit Drugs 87
REFERENCES 195 U.S. Food and Drug Administration, Division of Manufacturing and Product Quality, International Compliance Team. Inspections, Compliance, Enforcement, and Criminal Investigations. Warning Letter (WL: 320-09-01) to Dr. Mao Jian Yi, General Manager, Shanghai No. 1 Biochemical & Pharmaceutical Co. Ltd. April 14, 2009. 196 Ibid. 197 Ibid. 198 Kishimoto, Takashi Kei, Viswanathan, Karthik, et al. Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System. N Engl J Med, June 5, 2008, 358: 2457–67. 199 André, Philippe. Director, Qualiau Pharmaceutical Auditing Co., Ltd.; Associate Professor, School of Pharmaceutical Science and Technology, Tianjin University. “Supervision of Chinese-Made Drug Substances.” Presentation at Pew Health Group Conference “After Heparin: A Roundtable on Ensuring the Safety of the U.S. Drug Supply.” March 14, 2011. http:// prescriptionproject.org/assets/pdfs/Andre.pdf. Accessed May 13, 2011. 200 André, Philippe. Director, Qualiau Pharmaceutical Auditing Co., Ltd.; Associate Professor, School of Pharmaceutical Science and Technology, Tianjin University. “API Manufacturing Situation in China.” Presentation to European Fine Chemicals Group, May 13, 2009. 201 Ibid. 202 Henkel, John. Probe Proves Effective against Antibiotic Smuggling Scheme. FDA Consumer. January–February 1998. http://permanent.access.gpo.gov/lps1609/www.fda.gov/fdac/departs/1998/198_irs.html. Accessed February 21, 2010. 203 Thompson, Cheryl A. FDA Admits to Lacking Control over Counterfeit Drug Imports. Health-System Pharmacists News, American Society of Health-System Pharmacists. June 9, 2000. http://www.ajhp.org/content/57/14/1296.citation. Accessed February 21, 2010. 204 Ibid. 205 Henkel, John. Probe Proves Effective against Antibiotic Smuggling Scheme. FDA Consumer. January–February 1998. http://permanent.access.gpo.gov/lps1609/www.fda.gov/fdac/departs/1998/198_irs.html. Accessed February 21, 2010. 206 Ibid. 207 U.S. Department of Justice. “New Jersey Drug Firm and Owner Sentenced and Fined in Illegal Pharmaceutical and Money Laundering Scheme.” Press release. Thursday, April 10, 1997. 208 Thompson, Cheryl A. FDA Admits to Lacking Control over Counterfeit Drug Imports. Health-System Pharmacists News, American Society of Health-System Pharmacists. June 9, 2000. http://www.ajhp.org/content/57/14/1296.citation. Accessed February 21, 2010. 209 U.S. Centers for Disease Control and Prevention. “Endotoxin-Like Reactions Associated with Intravenous Gentamicin— California, 1998.” Morbidity and Mortality Weekly Report, October 23, 1998, 47(41):877–880. 210 Ibid. 211 Thompson, Cheryl A. FDA Admits to Lacking Control over Counterfeit Drug Imports. Health-System Pharmacists News, American Society of Health-System Pharmacists. June 9, 2000. http://www.ajhp.org/content/57/14/1296.citation. Accessed February 21, 2010. 212 Wienen, Frank, Ralph Deubner, and Ulrike Holzgrabe. Composition and Impurity Profile of Multisource Raw Material of Gentamicin—a Comparison. Pharmeuropa, April 2003, Vol. 15, No. 2. 213 Lewis, Carol. FDA Investigators’ Reports—January–February 2002. FDA Consumer Magazine. January 4, 2002. 214 U.S. Food and Drug Administration. The Enforcement Story, Fiscal Year 2001. Chapter 6: Office of Criminal Investigation. http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm106657.htm. Accessed August 22, 2010. 215 Ibid. 216 Lewis, Carol. FDA Investigators’ Reports—January–February 2002. FDA Consumer Magazine. January 4, 2002. 217 Ibid. 218 U.S. Food and Drug Administration. The Enforcement Story, Fiscal Year 2005. Chapter 6: Office of Criminal Investigations. March 2006. http://www.fda.gov/downloads/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ UCM091079.pdf. Accessed August 22, 2010. 88 Pew Health Group
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After Heparin: Protecting Consumers
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TABLE OF CONTENTS 1.4 Problems with
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Executive Summary In late 2007, U.S
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Executive Summary eventually being
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Introduction and Background U.S. ph
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INTRODUCTION AND BACKGROUND less ri
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50 0 INTRODUCTION AND BACKGROUND un
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INTRODUCTION AND BACKGROUND in Chin
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CHAPTER1 PHARMACEUTICAL MANUFACTURI
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PHARMACEUTICAL MANUFACTURING: GLOBA
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Page 29 and 30: PHARMACEUTICAL MANUFACTURING: GLOBA
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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: REFERENCES 155 State Food and Drug
Page 83 and 84: REFERENCES 244 U.S. Food and Drug A
Page 85 and 86: REFERENCES 289 U.S. Food and Drug A
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
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