메뉴 건너뛰기




Volumn 65, Issue 3, 2010, Pages

Heparin crisis 2008: A tipping point for increased FDA enforcement in the pharma sector?

Author keywords

[No Author keywords available]

Indexed keywords


EID: 84881394944     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (9)

References (55)
  • 1
    • 84881416322 scopus 로고    scopus 로고
    • Report: FDA So Underfunded, Consumers Are Put At Risk
    • December 2, available at last visited July 13, 2010
    • Julie Schmit, Report: FDA So Underfunded, Consumers Are Put At Risk, USA Today, December 2, 2007, available at http://www.usatoday.com/news/washington/ 2007-12-02-fda-N.htm (last visited July 13, 2010).
    • (2007) USA Today
    • Schmit, J.1
  • 2
    • 84881413535 scopus 로고    scopus 로고
    • press release, April 6, available at last visited July 13, 2010
    • Tufts Center for the Study of Drug Development, press release, New Approaches to R&D May Prove Best Path for Drug Developers, April 6, 2010, available at http://csdd.tufts.edu/news/complete-story/rd-pr-april-2010 (last visited July 13, 2010).
    • (2010) New Approaches to R&D May Prove Best Path for Drug Developers
  • 4
    • 53849085511 scopus 로고    scopus 로고
    • Outsourcing Strategies of Emerging Pharma
    • October 2, available at last visited July 13, 2010
    • Patricia Van Arnum, Outsourcing Strategies of Emerging Pharma, Pharmaceutical Technology, October 2, 2008, available at http://pharmtech. findpharma.com/pharmtech/article/articleDetail.jsp?id=557186 (last visited July 13, 2010).
    • (2008) Pharmaceutical Technology
    • Van Arnum, P.1
  • 5
    • 77952203657 scopus 로고    scopus 로고
    • Navigating the Global Pharmaceutical Supply Chain
    • March 2, available at last visited July 13, 2010
    • Patricia Van Arnum, Navigating the Global Pharmaceutical Supply Chain, Pharmaceutical Technology, March 2, 2010, available at http://pharmtech. findpharma.com/pharmtech/Ingredients+Insider/Navigating-the-Global- Pharmaceutical-Supply-Chain/ArticleStandard/Article/detail/660521 (last visited July 13, 2010).
    • (2010) Pharmaceutical Technology
    • Van Arnum, P.1
  • 6
    • 84881473308 scopus 로고    scopus 로고
    • Best Practices in the Supply Chain
    • available at last visited July 13, 2010
    • Patricia Van Arnum, Best Practices in the Supply Chain, Pharmaceutical Technology, available at http://pharmtech.findpharma.com/pharmtech/Article/Best- Practices-in-the-Supply-Chain/ArticleStandard/Article/detail/601481 (last visited July 13, 2010).
    • Pharmaceutical Technology
    • Van Arnum, P.1
  • 7
    • 84881435011 scopus 로고    scopus 로고
    • Quality in the Global Pharmaceutical Supply Chain
    • February/March available at: last visited July 13, 2010
    • Nikki Willett, Quality in the Global Pharmaceutical Supply Chain, Pharmaceutical Formulation & Quality, February/March 2010, available at: http://pharmaquality.com/ME2/Audiences/dirmod.asp?sid= 325598564E8C4B3EB736C7159241312D&nm=Browse+Articles&type= Publishing&mod=Publications%3A%3AArticle&mid= D3E3C719D8D44216836DCA4F4144BEC4&tier=4&id= 5EF71F0E39E44CABA65123BCCBE1EA0A&AudID=5648A5C28C97462DBBDB309539B820EF (last visited July 13, 2010).
    • (2010) Pharmaceutical Formulation & Quality
    • Willett, N.1
  • 8
    • 84881447076 scopus 로고    scopus 로고
    • GMP implementation in China: A double-edged sword for the pharmaceutical industry
    • available at last visited July 13, 2010
    • Ruoyan Gai et al, GMP implementation in China: A double-edged sword for the pharmaceutical industry, Drug Discoveries & Therapeutics 2007; 1(1):12-13, available at http://www.ddtjournal.com/action/downloaddoc.php?docid= 20 (last visited July 13, 2010).
    • (2007) Drug Discoveries & Therapeutics , vol.1 , Issue.1 , pp. 12-13
    • Gai, R.1
  • 9
    • 84881411619 scopus 로고    scopus 로고
    • Weak Links: A recent survey suggests that manufacturers don't have as much control over supply chain security as they think they do
    • available at: last visited July 13, 2010
    • Carla Reed, Weak Links: A recent survey suggests that manufacturers don't have as much control over supply chain security as they think they do, Pharmaceutical Manufacturing, 2008, available at: http://www. pharmamanufacturing.com/articles/2008/115.html (last visited July 13, 2010).
    • (2008) Pharmaceutical Manufacturing
    • Reed, C.1
  • 10
    • 0036164966 scopus 로고    scopus 로고
    • Letter-to-the Editor
    • January available at last visited July 13, 2010
    • David K. Cundiff, Letter-to-the Editor of the Journal of General Internal Medicine, January 2002, available at http://resources.metapress.com/pdf- preview.axd?code=d81201t603284876&size=largest (last visited July 13, 2010).
    • (2002) Journal of General Internal Medicine
    • Cundiff, D.K.1
  • 12
    • 84881467396 scopus 로고    scopus 로고
    • The Heparin Story
    • February 23, available at (last visited June 8, 2010) and http://www.biocentury.com/biotech-pharma-news/reg last visited July 13, 2010
    • Steve Usdin, The Heparin Story, BioCentury, February 23, 2009, available at http://www.momentapharma.com/HeparinBIOCentury.pdf (last visited June 8, 2010) and http://www.biocentury.com/biotech-pharma-news/regulation/2009-02-23/ cover-story-regulation-the-heparin-story-a1 (last visited July 13, 2010).
    • (2009) BioCentury
    • Usdin, S.1
  • 13
    • 84881419777 scopus 로고    scopus 로고
    • Anon, March available at last visited July 13, 2010
    • Anon, March 2008, Heparin Crisis Rekindles Concern About Disease From Pig Transplants, available at http://www.animalpeoplenews.org/08/3/ heparincrisisrekindlesconcern0308.htm (last visited July 13, 2010).
    • (2008) Heparin Crisis Rekindles Concern about Disease from Pig Transplants
  • 14
    • 84881409306 scopus 로고    scopus 로고
    • FDA Faulted in Heparin Case
    • April 29, available at last visited June 8, 2010
    • Alicia Mundy, FDA Faulted in Heparin Case, Wall Street Journal, April 29, 2010, available at http://online.wsj.com/article/ SB10001424052748703572504575214420823549694.html (last visited June 8, 2010).
    • (2010) Wall Street Journal
    • Mundy, A.1
  • 15
    • 84881470872 scopus 로고    scopus 로고
    • LawyersandSettlements.com, April 15 available at last visited July 13, 2010
    • Gordon Gibb, Heparin Counterfeit Seven Times Cheaper than the Real Thing, LawyersandSettlements.com, April 15 2008, available at http://www. lawyersandsettlements.com/articles/10432/heparin-counterfeit-cheaper.html (last visited July 13, 2010).
    • (2008) Heparin Counterfeit Seven Times Cheaper Than the Real Thing
    • Gibb, G.1
  • 16
    • 84881456531 scopus 로고    scopus 로고
    • Heparin Recall: Another Crisis for China & the FDA
    • available at last visited July 13, 2010
    • Susan Briones, Heparin Recall: Another Crisis for China & the FDA , University of Houston Health Law Perspectives, available at http://www.law.uh. edu/healthlaw/perspectives/2008/(SB)%20heparin.pdf (last visited July 13, 2010).
    • Health Law Perspectives
    • Briones, S.1
  • 17
    • 38949094248 scopus 로고    scopus 로고
    • Acute Allergic-Type Reactions Among Patients Undergoing Hemodialysis - Multiple States, 2007-2008
    • February 1, available at last visited July 13, 2010
    • G. Turabelidse et al, Acute Allergic-Type Reactions Among Patients Undergoing Hemodialysis - Multiple States, 2007-2008, Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report, February 1, 2008, available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm57e201a1.htm (last visited July 13, 2010).
    • (2008) Morbidity and Mortality Weekly Report
    • Turabelidse, G.1
  • 18
    • 84881419777 scopus 로고    scopus 로고
    • March available at last visited June 8, 2010
    • Animal People, March 2008, Heparin Crisis Rekindles Concern About Disease From Pig Transplants, available at http://www.animalpeoplenews.org/08/3/ heparincrisisrekindlesconcern0308.htm (last visited June 8, 2010).
    • (2008) Heparin Crisis Rekindles Concern about Disease from Pig Transplants
  • 19
    • 70449572936 scopus 로고    scopus 로고
    • From Crisis to Opportunity: A Perspective on the Heparin Crisis
    • available at last visited June 8, 2010
    • R. Sasisekharan & Z. Shriver, From Crisis to Opportunity: A Perspective on the Heparin Crisis, Thromb Haemost 102(5):854-8 (2009), available at http://pubget.com/paper/19888519 (last visited June 8, 2010).
    • (2009) Thromb Haemost , vol.102 , Issue.5 , pp. 854-858
    • Sasisekharan, R.1    Shriver, Z.2
  • 20
    • 84877829368 scopus 로고    scopus 로고
    • Heparin Recall: Another Crisis for China & the FDA
    • April available at last visited June 8, 2010
    • Susan Briones, Heparin Recall: Another Crisis for China & the FDA, Health Law Perspectives (April 2008), available at http://www.law.uh.edu/ Healthlaw/perspectives/2008/(SB)%20heparin.pdf (last visited June 8, 2010).
    • (2008) Health Law Perspectives
    • Briones, S.1
  • 22
    • 84881467396 scopus 로고    scopus 로고
    • The Heparin Story
    • February 23, available at last visited June 8, 2010
    • Steve Usdin, The Heparin Story, BioCentury, February 23, 2009, available at http://www.momentapharma.com/HeparinBIOCentury.pdf (last visited June 8, 2010).
    • (2009) BioCentury
    • Usdin, S.1
  • 23
    • 70449572936 scopus 로고    scopus 로고
    • From Crisis to Opportunity: A Perspective on the Heparin Crisis
    • R. Sasisekharan & Z. Shriver, From Crisis to Opportunity: A Perspective on the Heparin Crisis, Thromb Haemost 102(5):854-8 (2009).
    • (2009) Thromb Haemost , vol.102 , Issue.5 , pp. 854-858
    • Sasisekharan, R.1    Shriver, Z.2
  • 24
    • 84881412381 scopus 로고    scopus 로고
    • Information on Heparin Update: Follow up to the Public Health Alert about Changes to the Heparin Sodium
    • April 7, available at last visited June 8, 2010
    • U.S. Food and Drug Administration Information on Heparin Update: Follow up to the Public Health Alert about Changes to the Heparin Sodium USP Monograph (April 7, 2010), available at http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm112597.htm (last visited June 8, 2010).
    • (2010) USP Monograph
  • 25
    • 84881433983 scopus 로고    scopus 로고
    • FDA Withholds List of Chinese Heparin Suppliers From Probe by Congress
    • May 10, available at last visited June 8, 2010
    • Alicia Mundy, FDA Withholds List of Chinese Heparin Suppliers From Probe by Congress, Wall Street Journal, May 10, 2008, available at http://www.mindfully.org/Health/2008/FDA-Chinese-Heparin10may08.htm (last visited June 8, 2010).
    • (2008) Wall Street Journal
    • Mundy, A.1
  • 27
    • 84881407998 scopus 로고    scopus 로고
    • PharmaManufacturing.com, available at last visited June 8, 2010
    • A. Stanley, P. Thomas, M.V. Wagner & E. Ciurczak, Lessons from Heparin, PharmaManufacturing.com, available at http://www.pharmamanufacturing. com/articles/2008/123.html (last visited June 8, 2010).
    • Lessons from Heparin
    • Stanley, A.1    Thomas, P.2    Wagner, M.V.3    Ciurczak, E.4
  • 28
    • 84878966553 scopus 로고    scopus 로고
    • April available at last visited July 13, 2010
    • FDA Warning Letter, April 2008, available at http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/ EnforcementActivitiesbyFDA/ WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm054109. pdf (last visited July 13, 2010).
    • (2008) FDA Warning Letter
  • 29
    • 84881433983 scopus 로고    scopus 로고
    • FDA Withholds List of Chinese Heparin Suppliers From Probe by Congress
    • May 10
    • Alicia Mundy, FDA Withholds List of Chinese Heparin Suppliers From Probe by Congress, Wall Street Journal, May 10, 2008.
    • (2008) Wall Street Journal
    • Mundy, A.1
  • 30
    • 84881454229 scopus 로고    scopus 로고
    • House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations Holds a Hearing on Heparin
    • April 29, available at last visited June 8, 2010
    • Political Transcript Wire, House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations Holds a Hearing on Heparin (April 29, 2008), available at http://findarticles.com/p/news-articles/political- transcript-wire/mi-8167/is-20080430/rep-bart-stupak-holds-hearing/ai-n50727255/ (last visited June 8, 2010).
    • (2008) Political Transcript Wire
  • 31
    • 84881468253 scopus 로고    scopus 로고
    • F.D.A. Broke Its Rules by Not Inspecting Chinese Plaint with Problem Drug
    • Feb. 15, available at last visited June 8, 2010
    • Gardiner Harris & Walt Bogdanich, F.D.A. Broke Its Rules by Not Inspecting Chinese Plaint with Problem Drug, New York Times (Feb. 15, 2008), available at http://www.nytimes.com/2008/02/15/washington/15fda.html (last visited June 8, 2010).
    • (2008) New York Times
    • Harris, G.1    Bogdanich, W.2
  • 32
    • 84881456531 scopus 로고    scopus 로고
    • Heparin Recall: Another Crisis for China & the FDA
    • University of Houston
    • Susan Briones, Heparin Recall: Another Crisis for China & the FDA, University of Houston Health Law Perspectives.
    • Health Law Perspectives
    • Briones, S.1
  • 33
    • 84881409306 scopus 로고    scopus 로고
    • FDA Faulted in Heparin Case
    • April 29
    • Alicia Mundy, FDA Faulted in Heparin Case, Wall Street Journal, April 29, 2010.
    • (2010) Wall Street Journal
    • Mundy, A.1
  • 34
    • 84881436344 scopus 로고    scopus 로고
    • press release, April 30, available at last visited June 8, 2010
    • House Energy and Commerce Committee Republicans press release, Congressmen reveal credible leads in contamination case (April 30, 2010), available at http://republicans.energycommerce.house.gov/News/PRArticle.aspx? NewsID=7832 (last visited June 8, 2010).
    • (2010) Congressmen Reveal Credible Leads in Contamination Case
  • 35
    • 84881395228 scopus 로고    scopus 로고
    • House Committee on Energy and Commerce letter to FDA Commissioner Margaret A. Hamburg April 30, available at last visited June 8, 2010
    • House Committee on Energy and Commerce letter to FDA Commissioner Margaret A. Hamburg (April 30, 2010), available at http://Republicans. EnergyCommerce.house.gov/Media/file/News/043010-Letter-to-FDA-Heparin.pdf (last visited June 8, 2010).
    • (2010)
  • 37
    • 84860268066 scopus 로고    scopus 로고
    • With Obama, Regulations Are Back in Fashion
    • May 12, available at last visited June 8, 2010
    • Eric Lipton, With Obama, Regulations Are Back in Fashion, New York Times, May 12, 2010, available at http://www.nytimes.com/2010/05/13/us/politics/ 13rules.html (last visited June 8, 2010).
    • (2010) New York Times
    • Lipton, E.1
  • 38
    • 77953911319 scopus 로고    scopus 로고
    • Chapter 10, available at last visited June 9, 2010
    • FDA Enforcement Statistics, Chapter 10, page 10-5, available at http://www.fda.gov/downloads/ICECI/EnforcementActions/EnforcementStory/ UCM129823.pdf (last visited June 9, 2010).
    • FDA Enforcement Statistics , pp. 10-15
  • 39
    • 84881420372 scopus 로고    scopus 로고
    • U.S. Opens food safety office in China after scares
    • available at last visited June 9, 2010
    • CNN report, U.S. opens food safety office in China after scares, available at http://www.cnn.com/2008/WORLD/asiapcf/11/19/china.fda.poisoned/ index.html (last visited June 9, 2010).
    • CNN Report
  • 40
  • 42
    • 84881436911 scopus 로고    scopus 로고
    • Facility Registration Fee
    • H.R. 759.IH, Section 741: available at last visited July 13, 2010
    • Bill Text 111th Congress (2009-10), H.R. 759.IH, Section 741: Facility Registration Fee, available at http://thomas.loc.gov/cgi-bin/query/F?c111:1:./ temp/~c111nA2KxP:e7663: (last visited July 13, 2010).
    • Bill Text 111th Congress (2009-10)
  • 43
    • 84881464596 scopus 로고    scopus 로고
    • Inspection of producers of drugs and active pharmaceutical ingredients
    • H.R. 759.IH, Section 202: available at last visited July 13, 2010
    • Bill Text 111th Congress (2009-10), H.R. 759.IH, Section 202: Inspection of producers of drugs and active pharmaceutical ingredients, available at http://thomas.loc.gov/cgi-bin/query/F?c111:1:./temp/~c111z3EVN1:e110303: (last visited July 13, 2010).
    • Bill Text 111th Congress (2009-10)
  • 44
    • 84881442644 scopus 로고    scopus 로고
    • Congress Introduces FDA Globalization Act of 2009
    • February 12, available at last visited June 8, 2010
    • Maribel Rios, Congress Introduces FDA Globalization Act of 2009, Pharmaceutical Technology, February 12, 2009, available at http://pharmtech. findpharma.com/pharmtech/Ingredients/Congress-Introduces-FDA-Globalization-Act- of-- 2009/ArticleStandard/Article/detail/580861 (last visited June 8, 2010).
    • (2009) Pharmaceutical Technology
    • Rios, M.1
  • 46
    • 84881470167 scopus 로고    scopus 로고
    • inPharmaTechnologist.com, available at last visited June 9, 2010
    • inPharmaTechnologist.com, FDA launches QbD pilot programme, available at http://www.inpharmatechnologist.com/Industry-Drivers/FDA-launches-QbD-pilot- programme (last visited June 9, 2010).
    • FDA Launches QbD Pilot Programme
  • 47
    • 84881421934 scopus 로고    scopus 로고
    • Pharmaceutical cGMPS for the 21st Century - A Risk-Based Approach: Second Progress Report and Implementation Plan Introduction
    • February 20, available at last visited June 9, 2010
    • FDA report, Pharmaceutical cGMPS for the 21st Century - A Risk-Based Approach: Second Progress Report and Implementation Plan Introduction, February 20, 2003, available at http://www.fda.gov/cder/gmp/gmp2004/GMP-finalreport2004. htm (last visited June 9, 2010).
    • (2003) FDA Report
  • 48
    • 0007212003 scopus 로고    scopus 로고
    • July 2, available at last visited June 8, 2010
    • Federal Register, July 2, 2008, available at http://www.fda.gov/OHRMS/ DOCKETS/98fr/E8-14999.htm (last visited June 8, 2010).
    • (2008) Federal Register
  • 49
    • 84881439426 scopus 로고    scopus 로고
    • September 22, available at last visited June 9, 2010
    • inPharmaTechnologist, FDA enlarges and extends QbD pilot programme, September 22, 2009, available at http://www.in- pharmatechnologist.com/ Processing-QC/FDA-enlarges-and-extends-QbD-pilot-programme (last visited June 9, 2010).
    • (2009) FDA Enlarges and Extends QbD Pilot Programme
  • 50
    • 84873871382 scopus 로고    scopus 로고
    • In China, Strong Debut for Supplier of Heparin
    • May 6, available at last visited June 9, 2010
    • Bettina Wassener, In China, Strong Debut for Supplier of Heparin, New York Times, May 6, 2010, available at http://www.nytimes.com/2010/05/07/ business/global/07drug.html (last visited June 9, 2010).
    • (2010) New York Times
    • Wassener, B.1
  • 51
    • 84881472375 scopus 로고    scopus 로고
    • FDA publication, April 7, available at last visited June 9, 2010
    • FDA publication, Heparin: Change in Reference Standard, April 7, 2010, available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm184687.htm (last visited June 9, 2010).
    • (2010) Heparin: Change in Reference Standard
  • 53
  • 55
    • 84881460263 scopus 로고    scopus 로고
    • Letter from FDA Commissioner Margaret A. Hamburg to Senator Charles E. Grassley, March 4, available at last visited June 9, 2010
    • Letter from FDA Commissioner Margaret A. Hamburg to Senator Charles E. Grassley, March 4, 2010, available at http://grassley.senate.gov/about/upload/ FDA-3-4-10-Hamburg-letter-to-Grassley-re-GAO-report-on-OCI.pdf (last visited June 9, 2010).
    • (2010)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.