Regulatory experiments and transnational networks: the governance of pharmacogenomics in Europe and the United States

References

• Abraham , J. and Davis , C. 2007 . Deficits, expectations and paradigms in British and American drug safety assessments: prising open the black box of regulatory science . Science, technology and human values , 32 : 399 – 431 . doi: 10.1177/0162243907301002
   Web of Science ®Google Scholar
• Abraham , J. and Reed , T. 2001 . Trading risks for markets: the international harmonisation of pharmaceuticals regulation . Health, risk and society , 3 ( 1 ) : 113 – 128 .
   Web of Science ®Google Scholar
• Altenstetter , C. and Permanand , A. 2007 . EU Regulation of medical devices and pharmaceuticals in comparative perspective . Review of policy research , 24 ( 5 ) : 385 – 405 . doi: 10.1111/j.1541-1338.2007.00291.x
   Google Scholar
• Anonymous , 2006 . FDA's IPRG Director Felix Frueh on VGDS so far and PGx in 2006 . Pharmacogenomics reporter , 8 February . Available from: http://www.genomeweb.com/dxpgx/fda-s-iprg-director-felix-frueh-vgds-so-far-and-pgx-2006
   Google Scholar
• Anonymous , 2010 . Biomarkers on a roll . Nature biotechnology , 28 ( 5 ), 431 . doi: 10.1038/nbt0510-431
   PubMed Web of Science ®Google Scholar
• Braithwaite , J. and Drahos , P. 2000 . Global business regulation , Cambridge : Cambridge University Press .
   Google Scholar
• Branca , M. , 2002 . FDA fosters pharmacogenomics . Bio-IT World , 12 June . Available from: http://www.bio-itworld.com/archive/061202/horizons_lesko.html
   Google Scholar
• Carpenter , D. 2010 . Reputation and power: organisational image and pharmaceutical regulation at the FDA , Princeton , NJ : Princeton University Press .
   Google Scholar
• Davis , C. and Abraham , J. 2011a . A comparative analysis of risk management strategies in European Union and United States pharmaceutical regulation . Health, risk and society , 13 ( 5 ) : 413 – 431 . doi: 10.1080/13698575.2011.596191
   Web of Science ®Google Scholar
• Davis , C. and Abraham , J. 2011b . The socio-political roots of pharmaceutical uncertainty in the evaluation of ‘innovative’ diabetes drugs in the European Union and the US . Social science and medicine , 72 : 1574 – 1581 . doi: 10.1016/j.socscimed.2011.02.035
   Web of Science ®Google Scholar
• Demortain , D. 2008 . From drug crises to regulatory change . Health, risk and society , 10 : 37 – 51 . doi: 10.1080/13698570701782437
   Web of Science ®Google Scholar
• Department of Health . 2003 . Our inheritance, our future: realising the potential of genetics in the NHS. White Paper . London : HMSO .
   Google Scholar
• EFPIA/IMI , 2006 . The Innovative Medicines Initiative: keys for success – industry input . Brussels : IMI . Available from: http://www.imi-europe.org/Lists/IMIPublicationDocuments/20070309_IMI_Keys_for_Success%20Final.pdf
   Google Scholar
• EMA , 2000 . Report to the CPMP on the EMEA seminar on the used of pharmacogenetics in the drug development process – 5 June 2000 . London : EMEA .
   Google Scholar
• EMA , 2003 . Concept paper on pharmacogenetics briefing meetings . London : EMEA .
   Google Scholar
• EMA , 2004 . The European Medicines Agency road map to 2010. Discussion paper . London : EMEA .
   Google Scholar
• EMA , 2008 . Reflection paper on pharmacogenomics in oncology . London : EMEA .
   Google Scholar
• EMA , 2009 . The European Medicines Agency's participation in Innovative Medicines Initiative (IMI) research projects . London : EMEA .
   Google Scholar
• EMA , 2010 . Reflection paper on co-development of pharmacogenomic biomarkers and assays in the context of drug development . London : EMEA .
   Google Scholar
• European Commission , 2002 . Life sciences and biotechnology: a strategy for Europe . Brussels : European Commission .
   Google Scholar
• European Commisson , 2008 . Revision of the Medical Devices Directives – public consultation . Brussels : European Commission .
   Google Scholar
• European Commission , 2010 . Revision of Directive 98/79/ec of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices: public consultation . Brussels : European Commission .
   Google Scholar
• FDA , 2003 . Pharmacogenetic data submissions. Draft guidance . Rockville , MD : FD .
   Google Scholar
• FDA , 2004a . Critical path initiative . Rockville , MD : FDA .
   Google Scholar
• FDA , 2004b . Advisory Committee for Pharmaceutical Science, Clinical Pharmacology Subcommittee 4 November meeting transcript . Rockville , MD : FD .
   Google Scholar
• FDA , 2011 . Draft guidance for industry: in vitro companion diagnostic devices . Rockville , MD : FD .
   Google Scholar
• Goodsaid , F. and Amati , M. 2010 . Evolution of biomarker qualification at the health authorities . Nature biotechnology , 28 ( 5 ) : 441 – 443 . doi: 10.1038/nbt0510-441
   Web of Science ®Google Scholar
• Goodsaid , F. and Frueh F. , 2006 . Celebrating the two-year milestone and planning for the future of voluntary genomics data submissions (VGDS) to the FDA . Presentation for DIA webinar , 28 September . Available from: http://www.fda.gov/downloads/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm085612.pdf
   Google Scholar
• Goodsaid , F. 2010 . Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact . Nature reviews drug discovery , 9 : 435 – 445 . doi: 10.1038/nrd3116
   PubMed Web of Science ®Google Scholar
• Hamburg , M. , 2011 . America's innovation agency: the FDA . Wall Street journal , 1 August . Available from: http://online.wsj.com/article/SB10001424053111904888304576474072017155038.html
   Google Scholar
• Hauray , B. and Urfalino , P. 2009 . Mutual transformation and the development of European policy spaces: the case of medicines licensing . Journal of European public policy , 16 ( 3 ) : 431 – 449 . doi: 10.1080/13501760802662714
   Web of Science ®Google Scholar
• Hogarth , S. 2006 . Regulating pharmacogenomics: an overview of developments in various countries and industry response to regulatory initiatives. Report for Health Canada , Cambridge : University of Cambridge Press .
   Google Scholar
• Hogarth , S. and Salter , B. 2010 . Regenerative medicine in Europe: global competition and innovation governance . Regenerative medicine , 5 ( 6 ) : 971 – 985 . doi: 10.2217/rme.10.81
   PubMed Web of Science ®Google Scholar
• Hogarth , S. 2007 . Closing the gaps – enhancing the regulation of genetic tests using responsive regulation . Food and drug law journal , 62 ( 4 ) : 831 – 848 .
   Web of Science ®Google Scholar
• Hood , C. , Rothstein , H. and Baldwin , J. 2001 . The government of risk – understanding risk regulation regimes , Oxford : Oxford University Press .
   Google Scholar
• Hopkins , M. 2006 . Putting pharmacogenetics into practice . Nature biotechnology , 24 ( 4 ) : 403 – 410 . doi: 10.1038/nbt0406-403
   PubMed Web of Science ®Google Scholar
• Hopkins , M.P . 2007 . The myth of the biotech revolution: an assessment of technological, clinical and organisational change . Research policy , 36 ( 4 ) : 566 – 589 . doi: 10.1016/j.respol.2007.02.013
   Web of Science ®Google Scholar
• Jasanoff , S. 2005 . Designs on nature: science and democracy in Europe and the United States , Princeton , NJ : Princeton University Press .
   Google Scholar
• Lesko , L. , 2005 . Managing regulatory uncertainty: USA-FDA perspectives and strategies, presentation at OECD workshop on pharmacogenomics . Rome , October . Available from: http://www.oecd.org/dataoecd/34/60/35641440.pdf
   Google Scholar
• Lesko , L. and Woodcock , J. 2004 . Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective . Nature reviews drug discovery , 3 : 763 – 769 . doi: 10.1038/nrd1499
   PubMed Web of Science ®Google Scholar
• Levi-Faur , D. 2005 . The global diffusion of regulatory capitalism . The annals of the American Academy of Political and Social Science , 598 ( 12 ) : 1 – 22 .
   Google Scholar
• Macey , J.R. , 2003 . Regulatory globalization as a response to regulatory competition . Faculty Scholarship Series. Paper 1418. Available from: http://digitalcommons.law.yale.edu/fss_papers/1418
   Google Scholar
• Mattes , W. 2010 . Research at the interface of industry, academia and regulatory science . Nature biotechnology , 28 ( 5 ) : 432 – 433 . doi: 10.1038/nbt0510-432
   Web of Science ®Google Scholar
• Mikler , J. 2008 . Sharing sovereignty for global regulation: the cases of fuel economy and online gambling . Regulation and governance , 2 : 383 – 404 . doi: 10.1111/j.1748-5991.2008.00048.x
   Web of Science ®Google Scholar
• Millo , Y. and Lezaun , J. 2006 . Regulatory experiments: genetically modified crops and financial derivatives on trial . Science and public policy , 33 ( 3 ) : 179 – 190 . doi: 10.3152/147154306781779046
   Google Scholar
• Rose , N. 2006 . The politics of life itself: biomedicine, power and subjectivity in the twenty-first century , Princeton , NJ : Princeton University Press .
   Google Scholar
• Salter , B. and Jones , M. 2002 . Human genetic technologies: European governance and the politics of bioethics . Nature reviews genetics , 3 ( 10 ) : 808 – 814 . doi: 10.1038/nrg912
   Web of Science ®Google Scholar
• Vogel , D. 1998 . The globalization of pharmaceutical regulation . Governance , 11 : 1 – 22 . doi: 10.1111/0952-1895.551998055
   Web of Science ®Google Scholar
• Wilson-Kovacs , D. , Weber , S. and Hauskeller , C. 2009 . Stem cells clinical trials for cardiac repair: regulation as practical accomplishment . Sociology of health and illness , 32 ( 2 ) : 1 – 17 .
   Google Scholar
• Woodcock , J. and Lesko , L. 2009 . Pharmacogenetics – tailoring treatment for the outliers . New England journal of medicine , 360 ( 8 ) : 811 – 813 . doi: 10.1056/NEJMe0810630
   Web of Science ®Google Scholar