A comparative analysis of risk management strategies in European Union and United States pharmaceutical regulation

References

• Abraham , J. 1995 . Science, politics and the pharmaceutical industry , London/New York : UCL/St Martins Press .
   Google Scholar
• Abraham , J. and Davis , C. 2005a . Risking public safety: Experts, the medical profession and ‘acceptable’ drug injury . Health, Risk & Society , 7 : 379 – 395 .
   Web of Science ®Google Scholar
• Abraham , J. and Davis , C. 2005b . A comparative analysis of drug safety withdrawals in the UK and the US (1971–1992) . Social Science and Medicine , 61 : 881 – 892 .
   PubMed Web of Science ®Google Scholar
• Abraham , J. and Davis , C. 2006 . Testing times: The emergence of the practolol disaster and its challenge to British drug regulation in the modern period . Social History of Medicine , 19 : 127 – 147 .
   PubMed Web of Science ®Google Scholar
• Abraham , J. and Davis , C. 2009 . Drug evaluation and the permissive principle: Continuities and contradictions between standards and practices in antidepressant regulation . Social Studies of Science , 39 : 569 – 598 .
   PubMed Web of Science ®Google Scholar
• Abraham , J. and Davis , C. 2010 . Discovery and management of adverse drug reactions: The nomifensine hypersensitivity syndrome, 1977–86 . Social History of Medicine , 23 : 153 – 173 .
   Google Scholar
• Abraham , J. and Lewis , G. 2000 . Regulating medicines in Europe: Competition, expertise and public health , London : Routledge .
   Google Scholar
• Abraham , J. and Millstone , E. 1989 . Food additive controls: Some international comparisons . Food Policy , 14 : 43 – 57 .
   Web of Science ®Google Scholar
• Abraham , J. and Reed , T. 2001 . Trading risks for markets: The international harmonization of pharmaceuticals regulation . Health, Risk & Society , 3 : 113 – 128 .
   Web of Science ®Google Scholar
• Alivisatos , R. 1997 . FDA Medical Officer's Review of NDA 20-759 (Trovan), 20 July
   Google Scholar
• Alivisatos , R. 1998 . FDA Medical Officer's Review. Post-Marketing Adverse Events NDA 20-760 (Trovan), 31 August
   Google Scholar
• Andersson , F. 1992 . The drug lag issue: The debate seen from an international perspective . International Journal of Health Services , 22 : 53 – 72 .
   PubMedGoogle Scholar
• Anon . 2001a . More restrictions for Orlaam . Scrip , : 14 3 January
   Google Scholar
• Anon . 2001b . Orlaam suspended in EC . Scrip , : 12 25 April
   Google Scholar
• Anon . 2003 . Roxane to discontinue Orlaam in the US . Scrip , : 11 17 September
   Google Scholar
• Anon . 2004 . Tasmar EU suspension to be lifted, but with closer monitoring . Scrip , : 12 30 April
   Google Scholar
• Bevan , G. 2008 . Changing paradigms of governance and regulation of quality of healthcare in England . Health, Risk & Society , 10 : 85 – 101 .
   Web of Science ®Google Scholar
• Blanchemanche , S. , Marette , S. , Roosen , J. and Verger , P. 2010 . ‘Do not eat fish more than twice a week’: Rational choice, regulation and risk communication . Health, Risk & Society , 12 : 271 – 292 .
   Web of Science ®Google Scholar
• Brickman , R. , Jasanoff , S. and Ilgen , T. 1985 . Controlling chemicals: The politics of regulation in Europe and the US , Ithaca, NY : Cornell University Press .
   Google Scholar
• Chapman , A. 2006 . Regulating chemicals: From risks to riskiness . Risk Analysis , 26 : 603 – 616 .
   PubMed Web of Science ®Google Scholar
• Cox , L. A. 2007 . Does concern-driven risk management provide a viable alternative to QRA . Risk Analysis , 27 : 27 – 43 .
   PubMed Web of Science ®Google Scholar
• Currie , G. , Humphreys , M. , Waring , J. and Rowley , E. 2009 . Narratives of professional regulation and patient safety: Medical devices in anaesthetics . Health, Risk & Society , 11 : 117 – 135 .
   Web of Science ®Google Scholar
• Daemmrich , A. 2004 . Pharmacopolitics: Drug regulation in the United States and Germany , Chapel Hill/London : University of North Carolina Press .
   Google Scholar
• Daemmrich , A. and Krucken , G. 2000 . Risk versus risk: Decision-making dilemmas in the United States and Germany . Science as Culture , 9 : 505 – 534 .
   PubMedGoogle Scholar
• Davis , C. and Abraham , J. 2010a . Rethinking innovation accounting in pharmaceutical regulation . Science, Technology & Human Values , 35 : 1 – 22 .
   Google Scholar
• Davis , C. and Abraham , J. 2010b . Desperately seeking cancer drugs: Explaining the emergence and outcomes of accelerated pharmaceutical regulation . Sociology of Health & Illness , 32 : 1 – 22 .
   PubMedGoogle Scholar
• Demortain , D. 2008 . From drug crises to regulatory change . Health, Risk & Society , 10 : 37 – 51 .
   Web of Science ®Google Scholar
• Earle , T. C. 2010 . Trust in risk management . Risk Analysis , 30 : 541 – 574 .
   PubMed Web of Science ®Google Scholar
• EMEA . 1997 . European Public Assessment Report (Tasmar)
   Google Scholar
• EMEA . 1998 . Recommendation for the Suspension of the Marketing Authorisation for Tasmar (tolcapone) – EU/1/97/044/001-006, CPMP/2457/98, 17 November
   Google Scholar
• EMEA . 1999a . Public Statement on Trovan (Trovafloxacin): Serious, Severe and Unpredictable Liver Injuries, EMEA/15770/99, 25 May
   Google Scholar
• EMEA . 1999b . Public Statement on Trovan (Trovafloxacin): Recommendation to Suspend the Marketing Authorisation in the European Union, EMEA/18046/99, 15 June
   Google Scholar
• EMEA . 1999c . Public Statement on Levacetylmethadol (Orlaam) – for Life-Threatening Cardiac Rhythm Disorders, EMEA/38436/99, 15 December
   Google Scholar
• EMEA . 2000 . Public Statement on Levacetylmethadol (Orlaam) – Life-Threatening Ventricular Rhythm Disorders, EMEA/38918/00, 19 December
   Google Scholar
• EMEA . 2001 . European Public Assessment Report, Revision 4 (Orlaam): CPMP Scientific Discussion, CPMP/169/97
   Google Scholar
• FDA . 1993 . Approved Label, NDA 20-315 (Orlaam)
   Google Scholar
• FDA . 1994 . FDA Consumer, November
   Google Scholar
• FDA . 1998 . FDA Talk Paper
   Google Scholar
• FDA . 1999a . Managing the risks from medical product use: Creating a risk management framework , Washington, DC : Department of Health and Human Services .
   Google Scholar
• FDA . 1999b . Public Health Advisory – Trovan, 9 June
   Google Scholar
• FDA . 2000 . CDER-PhRMA-AASLC Conference 2000, Clinical White Paper, November 2000
   Google Scholar
• Gillespie , B. , Eva , P. and Johnston , R. 1979 . Carcinogenic risk assessment in the US and Great Britain: The case of aldrin/dieldrin . Social Studies of Science , 9 : 265 – 301 .
   PubMed Web of Science ®Google Scholar
• Graham , D. J. , Drinkard , C. R. , Shatin , D. , Tsong , Y. and Burgess , M. J. 2001 . Liver enzyme monitoring in patients treated with troglitazone . Journal of the American Medical Association , 286 : 831 – 834 .
   PubMed Web of Science ®Google Scholar
• Halffman , W. 2005 . Science-policy boundaries: National styles? . Science and Public Policy , 32 : 457 – 467 .
   Google Scholar
• Hammitt , J. K. , Wiener , J. B. , Swedlow , B. , Kall , D. and Zhou , Z. 2005 . Precautionary regulation in Europe and the United States: A quantitative comparison . Risk Analysis , 25 : 1215 – 1228 .
   PubMed Web of Science ®Google Scholar
• Hancher , L. 1989 . Regulating for competition: Government, law, and the pharmaceutical industry in the UK and France Thesis (PhD). University of Amsterdam
   Google Scholar
• Hood , C. and Rothstein , H. 2001 . Risk regulation under pressure: Problem solving or blame shifting? . Administration & society , 33 : 21 – 53 .
   Web of Science ®Google Scholar
• Hood , C. , Rothstein , H. and Baldwin , R. 2001 . The government of risk: Understanding risk regulation regimes , Oxford : Oxford University Press .
   Google Scholar
• Jasanoff , S. 1986 . Risk management and political culture , New York : Russell Sage Foundation .
   Google Scholar
• Jasanoff , S. 2005 . Designs on nature: Science and democracy in Europe and the US , Princeton/Oxford : Princeton University Press .
   Google Scholar
• Katz , R. 1997 . FDA Supervisory Review of NDA 20-697, Tasmar, 6 April
   Google Scholar
• Keijsers , L. , Bossong , M. G. and Waarlo , A. J. 2008 . Participatory evaluation of a Dutch warning campaign for substance-users . Health, Risk & Society , 10 : 283 – 295 .
   Web of Science ®Google Scholar
• Kelman , S. 1981 . Regulating Sweden, regulating America: A comparative study of occupational health and safety policy , Cambridge, MA : MIT Press .
   Google Scholar
• La Revue Prescrire . 1999 . A review of new drugs . Prescrire International , 8 : 5 – 20 .
   PubMedGoogle Scholar
• Leitch , M. 2010 . ISO 31000:2009 – the new international standard on risk management . Risk Analysis , 30 : 887 – 892 .
   PubMed Web of Science ®Google Scholar
• Levidow , L. and Carr , S. 2000 . Normalizing novelty: Regulating biotechnological risk at the EPA . Risk , 11 : 9 – 34 .
   Google Scholar
• Lloyd-Bostock , S. M. and Hutter , B. M. 2008 . Reforming regulation of the medical profession: The risk of risk-based approaches . Health, Risk & Society , 10 : 69 – 83 .
   Web of Science ®Google Scholar
• Macrae , C. 2008 . Learning from patient safety incidents: Creating participative risk regulation in healthcare . Health, Risk & Society , 10 : 53 – 67 .
   Web of Science ®Google Scholar
• Osimani , B. 2010 . Pharmaceutical risk communication: Sources of uncertainty and legal tools of uncertainty management . Health, Risk & Society , 12 : 453 – 469 .
   Web of Science ®Google Scholar
• Purdy , G. 2010 . ISO 31000:2009 – setting a new standard for risk management . Risk Analysis , 30 : 881 – 886 .
   PubMed Web of Science ®Google Scholar
• Roche Hexagon . 1998 . Product Label for Tasmar
   Google Scholar
• Rothstein , H. 2006 . The institutional origins of risk . Health, Risk & Society , 8 : 215 – 221 .
   Web of Science ®Google Scholar
• Smalley , W. , Shatin , D. , Wysowski , D. K. Gurwitz , J. 2000 . Contraindicated use of cisapride: Impact of FDA regulatory action . Journal of the American Medical Association , 284 : 3036 – 3039 .
   PubMed Web of Science ®Google Scholar
• Taylor-Gooby , P. and Zinn , J. O. 2006 . Current directions in risk research . Risk Analysis , 26 : 397 – 411 .
   PubMed Web of Science ®Google Scholar
• Temin , P. 1980 . Taking your medicine: Drug regulation in the United States , Cambridge, MA : MIT Press .
   Google Scholar
• USNRC . 1983 . Risk assessment in the Federal Government: Managing the process , Washington DC : National Research Council .
   Google Scholar
• Van Zwanenberg , P. and Millstone , E. 2005 . BSE: Risk, science, and governance , Oxford : Oxford University Press .
   Google Scholar
• Vogel , D. 1986 . National styles of regulation: Environmental policy in Great Britain and the United States , Ithaca, NY : Cornell University Press .
   Google Scholar
• Vogel , D. 2003 . The hare and the tortoise revisited: The new politics of consumer and environmental regulation in Europe . British Journal of Political Science , 33 : 557 – 580 .
   Web of Science ®Google Scholar
• Waller , P. and Evans , S. 2002 . A model for the future conduct of pharmacovigilance . Pharmacoepidemiology and Drug Safety , 10 : 773 – 786 .
   Google Scholar
• Welsh , R. and Ervin , D. E. 2006 . Precaution as an approach to technology development: The case of transgenic crops . Science, Technology & Human Values , 31 : 153 – 172 .
   Google Scholar
• Wiktorowicz , M. E. 2003 . Emergent patterns in the regulation of pharmaceuticals: Institutions and interests in the US, Canada, Britain and France . Journal of Health, Politics, Policy and Law , 28 : 615 – 658 .
   PubMed Web of Science ®Google Scholar