After Heparin: - The Pew Charitable Trusts

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REFERENCES 265 U.S. Food and Drug Administration, Office of Compliance, Center for Drug Evaluation and Research. Warning Letter (WL: 320-11-0) to Mr. Kartikeya Sarabhai, Chairman, Synbiotics Limited c/o Ambalal Sarabhai Enterprises. Ahmadabad, India. December 16, 2010. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm237767.htm. Accessed January 20, 2011. 266 http://www.rx-360.com. 267 Bloom, Michael, Assistant Director for Policy & Coordination, Bureau of Competition, United States of America Federal Trade Commission. Letter to Ms. Joanne Lewers, Drinker Biddle & Reath LLP. September 15, 2010. 268 19 USC §1304. 269 19 CFR §134.1(d). 270 21 CFR §201.1 (a). 271 21 USC §351 (a)(2)(B). 272 21 USC §374. 273 Rothman, Barry. Division of Manufacturing & Product Quality, Office of Compliance, Center for Drug Evaluation & Research, “Pharmaceutical Ingredient Supply Chains.” Presentation at FDA News Supplier Management Congress, Arlington, Va., August 19–21, 2009. 274 Drug Industry Daily. FDA to Revise GMPs for Components to Protect Supply Chain. April 28, 2010, Vol. 7, No. 83. 275 21 CFR §210/211, applies to the manufacture, processing, packaging, and holding of drug products. 276 World Health Organization Quality Assurance guidelines. http://www.who.int/medicines/areas/quality_safety/quality_ assurance/en/. Accessed October 15, 2010. 277 U.S. Food and Drug Administration. Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations. September 2006. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm070337.pdf. Accessed December 8, 2010. 278 Hasselbalch, Brian. Division of Manufacturing and Product Quality, Office of Compliance, Center for Drug Evaluation and Research, “Public Health Challenges for the Quality of Human Drugs.” Presentation at FDA/Xavier University Global Outsourcing Conference, June 14–16, 2010. 279 Cox, Bowman. FDA Looks to Expand Drug GMPs Farther Up the Pharmaceutical Supply Chain. The Gold Sheet, October 1, 2009. 280 21 CFR §820. 281 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System. Current Step 4 version. June 4, 2008. http:// www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q10/Step4/Q10_Guideline.pdf. Accessed January 27, 2011. 282 21 CFR §820.50. 283 Guidance for Industry: Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. September 2001. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129098.pdf. Accessed January 27, 2011. 284 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline Q9: Quality Risk Management. Current Step 4 version. November 9, 2005. http:// www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf. Accessed January 27, 2011. 285 Cox, Bowman. Record Drug Recall Totals for 2009 Resulted from GMP Breakdowns. The Gold Sheet, May 2010, Vol. 44, No. 5. 286 Ibid. 287 Eglovitch, Joanne S. Enforcement on Steroids: FDA Delivers Twice the Drug GMP Warning Letters. The Gold Sheet, April 2010, Vol. 44, No. 4. 288 Sharfstein, Joshua. Deputy Commissioner, U.S. Food and Drug Administration. Testimony before the Committee on Oversight and Government Reform, U.S. House of Representatives. Hearing on Johnson & Johnson’s Recall of Children’s Tylenol and Other Children’s Medicines. May 27, 2010. After Heparin: PRotecting Consumers from the Risks of Substandard and Counterfeit Drugs 91
REFERENCES 289 U.S. Food and Drug Administration. Form FDA 483 Inspectional Observations. To Hakan Erdemir, Vice President of Operations, McNeil Consumer Healthcare, Division of McNeil-PPC, Inc. April 30, 2010. http://www.fda.gov/downloads/ AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/UCM210772.pdf. Accessed May 26, 2010. 290 U.S. Food and Drug Administration, Detroit District Office. Warning Letter (WL: 2010-DT-11) to Mr. Joseph C. Papa, President and Chief Executive Officer, L. Perrigo Company. April 29, 2010. http://www.fda.gov/ICECI/EnforcementActions/ WarningLetters/ucm213166.htm. Accessed November 11, 2010. 291 Ibid. 292 U.S. Food and Drug Administration. “L. Perrigo Co.” http://www.fda.gov/AboutFDA/CentersOffices/ORA/ ORAElectronicReadingRoom/ucm214720.htm. Accessed November 11, 2010. 293 U.S. Food and Drug Administration. “Acetaminophen 500 mg Caplets by Perrigo Company.” November 9, 2006. http:// www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150409.htm. Accessed November 11, 2010. 294 United States Department of Justice, Office of Public Affairs. GlaxoSmithKline to Plead Guilty & Pay $750 Million to Resolve Criminal and Civil Liability Regarding Manufacturing Deficiencies at Puerto Rico Plant. Press Release. Tuesday, October 26, 2010. http://www.justice.gov/opa/pr/2010/October/10-civ-1205.html. Accessed November 14, 2010. 295 Riley, Karen. Genzyme Corp. Signs Consent Decree to Correct Violations at Allston, Mass., Manufacturing Plant and Give Up $175 Million in Profits. May 24, 2010. U.S. Food and Drug Administration. Electronic. http://www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/ucm213212.htm Accessed June 22, 2010. 296 Cox, Bowman. Record Drug Recall Totals for 2009 Resulted from GMP Breakdowns. The Gold Sheet, May 2010, Vol. 44, No. 5. 297 Eglovitch, Joanne S. Enforcement on Steroids: FDA Delivers Twice the Drug GMP Warning Letters. The Gold Sheet, April 2010, Vol. 44, No. 4. 298 21 CFR §211.165. 299 21 CFR §211.84; 21 CFR §211.110; 21 CFR §211.165. 300 21 CFR §314.50(d)(1) and 314.94(a)(9)(i). 301 Williams, Roger L. Official USP Reference Standards: Metrology concepts, overview, and scientific issues and opportunities. Journal of Pharmaceutical and Biomedical Analysis. January 23, 2006, Vol. 40, No.1. 302 21 USC §351 (b). 303 21 USC §355. 304 21 USC §351 (a)(1). 305 U.S. Food and Drug Administration, U.S. Customhouse, Philadelphia, PA. Form FDA 483, Inspectional Observations. To Hakan Erdemir, Vice President of Operations, McNeil Consumer Healthcare, Division of McNeil-PPC, Inc. April 30, 2010. http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/UCM210772.pdf. Accessed May 26, 2010. 306 U.S. Food and Drug Administration. Memorandum to Mr. Malvinder Mohan Singh, CEO & Managing Director, Ranbaxy Laboratories Limited. February 25, 2009. 307 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. 308 United States Pharmacopeial Convention. White Paper: USP’s Role in Setting Enforceable Quality Standards for Medicines. Council of the Convention Section on the Quality of Manufactured Medicines. September 23, 2009. 309 Williams, Roger. Chief Executive Officer, United States Pharmacopoeia. “Economically Motivated Adulteration.” Presentation at U.S. Food and Drug Administration Public Meeting on Economically Motivated Adulteration. May 1, 2009. 310 Ibid. 311 United States Pharmacopeial Convention. White Paper: USP’s Role in Setting Enforceable Quality Standards for Medicines. Council of the Convention Section on the Quality of Manufactured Medicines. September 23, 2009. 92 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 33 and 34: PHARMACEUTICAL MANUFACTURING: GLOBA
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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: REFERENCES 244 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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After Heparin: - The Pew Charitable Trusts

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