After Heparin: - The Pew Charitable Trusts

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REFERENCES 404 Tanner, John S., Chairman, Subcommittee on Trade, Committee on Ways and Means, U.S. House of Representatives. Opening Statement, Hearing on Customs Trade Facilitation and Enforcement in a Secure Environment. May 20, 2010. http://democrats.waysandmeans.house.gov/Hearings/transcript.aspx?NewsID=11181. Accessed November 14, 2010. 405 United States Department of Homeland Security. IT Program Assessment: CBP- Automated Commercial Environment (ACE)—International Trade Data System (ITDS). http://www.dhs.gov/xlibrary/assets/mgmt/itpa-cbp-ace-itds.pdf. Accessed November 14, 2010. 406 Office of Regulatory Affairs, Office of Resource Management, U.S. Food and Drug Administration. PREDICT: Briefing Slides for Importers and Entry Filers. http://www.fda.gov/downloads/ForIndustry/ImportProgram/UCM176726.pdf. Accessed January 26, 2011. 407 Autor, Deborah M., Director, CDER Office of Compliance. U.S. Food and Drug Administration. Email correspondence, March 20, 2011. 408 Ibid. 409 Federal Register, Secure Supply Chain Pilot Program; Notice of Pilot Program. January 15, 2009, Vol. 74, No. 10:2605–2608. 410 Public Law 111-353—January 4, 2011. FDA Food Safety Modernization Act. Section 807(b). http://gov/fdsys/pkg/PLAWillpub1353/pdf/PLAW-illpub1353.pdf. Accessed March 7, 2011. 411 21 USC §381(a). 412 Ibid. 413 21 CFR §7.40 (c). 414 Osborne, Walt D. MS, JD. FDA’s Recall Authority Is Important Arrow in Agency’s Enforcement Quiver. FDA Veterinarian Newsletter 2007 Volume XXII, No II. 415 U.S. Food and Drug Administration. FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer. FDA News Release. November 6, 2008. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116977.htm. Accessed November 11, 2010. 416 U.S. Department of Justice, Office of Legal Policy. Report to Congress on the Use of Administrative Subpoena Authorities by Executive Branch Agencies and Entities. http://www.justice.gov/archive/olp/rpt_to_congress.pdf. Accessed February 14, 2011. 417 U.S. Government Accountability Office (October 2010). U.S. Food and Drug Administration: Response to Heparin Contamination Helped Protect Public Health; Controls That Were Needed for Working with External Entities Were Recently Added (Publication No. GAO-11-95). 418 21 USC §333. 419 U.S. Drug Enforcement Administration. Federal Trafficking Penalties. http://www.justice.gov/dea/agency/penalties.htm. Accessed February 14, 2011. 420 Siak, Nadine Leavitt. United States Intensifies Fight against Counterfeit Drugs: Tougher Trademark Laws Considered, Say Justice Officials. USINFO. December 1, 2006. http://www.america.gov/st/washfile-english/2006/December/2006120112071 1LNkaiS0.2569086.html. Accessed May 3, 2010. 421 21 CFR §211.22. 422 21 CFR §820.20. 423 European Parliament. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use. 424 Fleder, John R. The Park Criminal Liability Doctrine: Is It Dead or Is It Awakening? The Food and Drug Law Institute. September/October 2009. http://www.fdli.org. 425 FDA Webview. Top FDA Litigator Warns Industry on Misdemeanor Prosecutions. April 22, 2010. 426 FDA Webview. FDA to Target CEOs Personally in Off-Label Promotion Suits. October 14, 2010. 427 Hamburg, Margaret A. MD. Commissioner, U.S. Food and Drug Administration. Letter to the Honorable Charles E. Grassley, Ranking Member, Senate Committee on Finance, United States Senate. March 4, 2010. http://grassley.senate. gov/about/upload/FDA-3-4-10-Hamburg-letter-to-Grassley-re-GAO-report-on-OCI.pdf. Accessed November 14, 2010. 428 Fleder, John R. The Park Criminal Liability Doctrine: Is It Dead or Is It Awakening? The Food and Drug Law Institute. September/October 2009. http://www.fdli.org. After Heparin: PRotecting Consumers from the Risks of Substandard and Counterfeit Drugs 97
REFERENCES 429 U.S. Supreme Court, United States v. Park, 421 U.S. 658 (1975). Argued March 18–19, 1975. Decided June 9, 1975. 430 Fleder, John R. The Park Criminal Liability Doctrine: Is It Dead or Is It Awakening? The Food and Drug Law Institute. September/October 2009. http://www.fdli.org. 431 FDA Webview. Top FDA Litigator Warns Industry on Misdemeanor Prosecutions. April 22, 2010. 432 FDA Webview. FDA to Target CEOs Personally in Off-label Promotion Suits. October 14, 2010. 433 Hamburg, Margaret A. MD. Commissioner, U.S. Food and Drug Administration. Letter to the Honorable Charles E. Grassley, Ranking Member, Senate Committee on Finance, United States Senate. March 4, 2010. http://grassley.senate. gov/about/upload/FDA-3-4-10-Hamburg-letter-to-Grassley-re-GAO-report-on-OCI.pdf. Accessed November 14, 2010. 434 21 CFR §314.81. 435 Sharfstein, Joshua. 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. 436 Cockburn, Robert et al. The Global Threat of Counterfeit Drugs: Why Industry and Governments Must Communicate the Dangers. PLoS Medicine, April 2005, Vol. 2, No. 4. 437 Ibid. 438 21 USC §331(j). 439 21 CFR §20.89. 440 Hamburg, Margaret. Commissioner, U.S. Food and Drug Administration. Testimony before the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations. April 13, 2011. http://republicans. energycommerce.house.gov/Media/file/Hearings/Oversight/041311/Hamburg.pdf. Accessed April 27, 2011. 441 Ireland, J. FDA letter to Representative Barton. June 16, 2010. http://republicans.energycommerce.house.gov/Media/file/ News/061610_FDA_Response_Heparin.pdf. Accessed February 17, 2011. 442 U.S. Food and Drug Administration. Report to Committee on Appropriations on FDA’s Approach to Medical Product Supply Chain Safety in Response to the Joint Explanatory Statement to Accompany H.R. 1105, the Omnibus Appropriations Act, 2009. July 2009. http://www.fda.gov/downloads/Safety/SafetyofSpecificProducts/UCM184049.pdf. Accessed January 27, 2011. 443 International Pharmaceutical Quality. International Joint API Inspection Pilot Program Sees Positive Results. July 19, 2010. http://www.ipqpubs.com/news/international-joint-api-inspection-pilot-program-sees-positive-results/. Accessed September 15, 2010. 444 Friedman, Rick. Director of the Division of Manufacturing & Product Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration. Remarks at Pew Health Group Conference “After Heparin: A Roundtable on Ensuring the Safety of the U.S. Drug Supply.” March 14, 2011. 445 Swain, Liz. Wyeth Rates Joint GMP Inspection by FDA and EMEA, but Sees Duplication. Inspection Monitor, August 2009. http://findarticles.com/p/articles/mi_6904/is_8_14/ai_n53201599/?tag=content;col1. Accessed September 15, 2010. 446 Foxhall, Kathryn. FDA Getting Tougher, Faster in Drug Inspections. FDA Webview. September 14, 2010. 447 Pharmaceutical Inspection Co-operation Scheme: Members and Partners. http://www.picscheme.org/members.php. Accessed January 27, 2011. 448 Autor, Deborah M., Director, CDER Office of Compliance. Remarks at Pew Health Group Conference “After Heparin: A Roundtable on Ensuring the Safety of the U.S. Drug Supply.” March 14, 2011. 449 Counterfeit Pharmaceutical Inter-Agency Working Group Report to the Vice President of the United States and Congress, March 2011. http://www.whitehouse.gov/sites/default/files/omb/IPEC/Pharma_Report_Final.pdf. Accessed April 13, 2011. 450 Hamburg, Margaret. A, Commissioner, U.S. Food and Drug Administration. Keynote presentation at the Partnership for Safe Medicines Interchange 2010, October 8, 2010. http://safemeds.typepad.com/files/safe-medicines-speech_final.pdf. Accessed October 13, 2010. 451 Public Law 111-353—January 4, 2011. FDA Food Safety Modernization Act. Section 808. http://gov/fdsys/pkg/PLAWillpub1353/pdf/PLAW-illpub1353.pdf. Accessed March 7, 2011. 452 U.S. Government Accountability Office (September 2010). Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed (Publication No. GAO-10-961). 98 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 39 and 40: 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 87 and 88: REFERENCES 332 Public Law 111-8—M
Page 89: REFERENCES 378 Villax, Guy. Board M
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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