The political dynamics of citizenship, innovation, and regulation in pharmaceutical governance

References

• Abraham , J. 1995 . Science, politics and the pharmaceutical industry , London/New York : UCL/St Martins Press .
   Google Scholar
• Abraham , J. and Lewis , G. 2000 . Regulating medicines in Europe , London : Routledge .
   Google Scholar
• Abraham , J. and Lewis , G. 2002 . Citizenship, medical expertise and the capitalist regulatory state in Europe . Sociology , 36 : 67 – 88 . doi: 10.1177/0038038502036001004
   Google Scholar
• Abraham , J. and Millstone , E. 1989 . Food additive controls: international comparisons . Food policy , 14 : 43 – 57 . doi: 10.1016/0306-9192(89)90025-0
   Web of Science ®Google Scholar
• Abraham , J. and Reed , T. 2002 . Progress, innovation and regulatory science in drug development . Social studies of science , 32 : 337 – 369 . doi: 10.1177/0306312702032003001
   PubMed Web of Science ®Google Scholar
• Abraham , J. and Sheppard , J. 1999 . Conflicting scientific expertise in British and American drug regulation . Social studies of science , 29 : 803 – 843 . doi: 10.1177/030631299029006001
   PubMed Web of Science ®Google Scholar
• AIDS Action Council , 1996 . Analysis of H.R. 3199: “The FDA Revitalization Act” .
   Google Scholar
• Anon ., 1988a . US FDA's expedited drug plan unveiled . Scrip , 1356, 18 .
   Google Scholar
• Anon ., 1988b . US PMA comments on expedited drug plan . Scrip , 1346, 17 .
   Google Scholar
• Anon ., 1989 . US FDA/NCI reconcile differences? Scrip , 1450, 20 .
   Google Scholar
• Anon ., 1996 . Kassebaum proposals unrealistic says Kessler . Scrip , 2107, 13 .
   Google Scholar
• Anon ., 2006 . EU launches new, less stringent conditional approvals procedure . Scrip , 3145, 3 .
   Google Scholar
• Anon ., 2007 . Guidance on conditional licensing out for comment . Scrip , 3221/22, 3 .
   Google Scholar
• Atkinson , M.M. and Coleman , W.D. 1985 . “ Corporatism and industrial policy ” . In Organized interests and the state , Edited by: Cawson , A. London : Sage .
   Google Scholar
• Brickman , R. , Jasanoff , S. and Ilgen , T. 1985 . Controlling chemicals: the politics of regulation in Europe and the United States , Ithaca , NY : Cornell University Press .
   Google Scholar
• Carpenter , D.P. 2004 . The political economy of FDA drug review . Health affairs , 23 : 52 – 63 . doi: 10.1377/hlthaff.23.1.52
   Web of Science ®Google Scholar
• Carpenter , D. 2010 . Reputation and power , Princeton , NJ : Princeton University Press .
   Google Scholar
• Carpenter , D. and Fendrick , A.M. 2004 . Accelerating approval times for new drugs in the US . Regulatory affairs journal – pharma , 15 : 411 – 417 .
   Google Scholar
• Cawson , A. 1986 . Corporatism and political theory , Oxford : Blackwell .
   Google Scholar
• CMS Cameron McKenna and Andersen Consulting , 2000 . Evaluation of the operation of Community procedures for the authorisation of medicinal products, October 2000 . European Commission, Directorate-General Enterprise, Pharmaceuticals and Cosmetics .
   Google Scholar
• Code of Federal Regulations , 1992 . CFR Part 314, Subpart H (Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses) .
   Google Scholar
• Commission of the European Communities , 2001 . Report from the Commission on the experience acquired as a result of the operation of the procedures for granting marketing authorisations for medicinal products laid down in Regulation (EEC) no . 2309/93 in chapter III of Directive 75/319/EEC and chapter IV of Directive 81/851/EEC , October .
   Google Scholar
• Council Regulation , 1993 . Council Regulation (EEC) no. 2309/93 of 22 July laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products . Official journal of the European Union , L214 ( 24 August ), 1 .
   Google Scholar
• Daemmrich , A. 2004 . Pharmacopolitics: drug regulation in the US and Germany , Chapel Hill , NC : University of North Carolina Press .
   Google Scholar
• Daemmrich , A. and Krucken , G. 2000 . Risk versus risk: decision-making dilemmas of drug regulation in the US and Germany . Science as culture , 9 : 505 – 534 . doi: 10.1080/713695270
   PubMedGoogle Scholar
• Dukes , M.N.G. 1985 . The effects of drug regulation , Lancaster : MTP Press .
   Google Scholar
• Epstein , S. 1997 . Activism, drug regulation and the politics of therapeutic evaluation in the AIDS era . Social studies of science , 27 : 691 – 726 . doi: 10.1177/030631297027005001
   PubMed Web of Science ®Google Scholar
• EURODIS , 2005 . EURODIS comments on the draft regulation on conditional marketing authorisation for medicinal products . Available at: http://www.eurordis.org/IMG/pdf/eurordis_comments_conditional_approval_jan05.pdf (accessed 13 May 2005) .
   Google Scholar
• European Commission , 1996 . Rules governing medicinal products in the EC Vol. IIA .
   Google Scholar
• European Public Health Alliance , 2003 . Public interest group on medicines launched. Update 63 . Available at: http://www.epha.org/a/509 (accessed 5 February 2012) .
   Google Scholar
• European Union , 2004 . Of the European Parliament and the Council, 31 March 2004. Laying down community procedures for the authorisation and supervision of medicinal products for hunam and veterinary use and for establishing a European Medicines Agency . Official journal of the European Union , L136 , 30 April .
   Google Scholar
• FDA , 1997 . Final performance report: Prescription Drug User Fee Act of 1992, fiscal year 1997 report to Congress , 1 December .
   Google Scholar
• FDA , 2001 . Public meeting: Prescription Drug User Fee Act (PDUFA) . Transcript of meeting, statement of Travis Plunkett, of Consumer Federation of America , 7 December .
   Google Scholar
• FDA Modernisation Act , 1997 . Section 506(b)(3) of the Food, Drug and Cosmetic Act (as amended by Section 112 of FDAMA) .
   Google Scholar
• FDA Oral History Program , 1997 . Interview with J. Richard Crout, M.D., Director of FDA's Bureau of Drugs, 1973–1982 .
   Google Scholar
• Federal Register , 1988 . 53 , Federal register , 41523, 21 October; codified as 21 CFR 312.80–312.88, Subpart E (Drugs Intended to Treat Life-Threatening and Severely-Debilitating Illnesses) .
   Google Scholar
• Federal Register , 2000 . 65 , Federal register , 47993, Prescription Drug User Fee Act (PDUFA); public meeting, 4 August, notice of public meeting, at 47994 .
   Google Scholar
• Fleming , T.R. 2005 . Surrogate endpoints and FDA's accelerated approval process . Health affairs , 24 : 67 – 78 . doi: 10.1377/hlthaff.24.1.67
   PubMed Web of Science ®Google Scholar
• Freeman , C. 1982 . The economics of industrial innovation , London : Pinter .
   Google Scholar
• Gale , E.A.M. 2001 . Lessons from the glitazones . Lancet , 357 : 1870 – 1875 . doi: 10.1016/S0140-6736(00)04960-6
   PubMed Web of Science ®Google Scholar
• Garattini , S. and Bertele , V. 2001 . Adjusting Europe's drug regulation to public health needs . Lancet , 358 : 64 – 67 . doi: 10.1016/S0140-6736(00)05258-2
   PubMed Web of Science ®Google Scholar
• Gillespie , B. 1979 . Carcinogenic risk assessment in US and Britain . Social studies of science , 9 : 265 – 301 . doi: 10.1177/030631277900900301
   PubMed Web of Science ®Google Scholar
• Halfmann , J. 1998 . Citizenship, universalism and risks of exclusion . British journal of sociology , 49 : 313 – 333 . doi: 10.2307/591286
   Web of Science ®Google Scholar
• Hilts , P.J. 2003 . Protecting America's health: the FDA, business and one hundred years of regulation , New York : Knopf .
   Google Scholar
• House of Commons , 2005 . Inquiry into the influence of the pharmaceutical industry . Health Select Committee Report .
   Google Scholar
• International Society of Drug Bulletins , 2001 . ISDB declaration on therapeutic advance in the use of medicines , Paris , 15–16 November .
   Google Scholar
• Jasanoff , S. 2005 . Designs on nature , Princeton , NJ : Princeton University Press .
   Google Scholar
• Jevons , F. 1992 . Who wins from innovation? . Technology analysis & strategic management , 4 : 399 – 412 . doi: 10.1080/09537329208524109
   Google Scholar
• Kelman , S. 1981 . Regulating America, regulating Sweden: a comparative study of occupational safety , Cambridge , MA : MIT Press .
   Google Scholar
• La Revue Prescrire 2004 Medicines in Europe: the most important changes in the new legislation . Prescrire international , 13 , 158–1 – 158-8 .
   Google Scholar
• Lexchin , J. 1990 . Drug makers and drug regulators . Social science and medicine , 31 : 1257 – 1263 . doi: 10.1016/0277-9536(90)90133-D
   PubMed Web of Science ®Google Scholar
• Link , D. , 1995 . Contracting out the FDA . GMHC treatment issues , 10 ( 5 ).
   Google Scholar
• Lofgren , H. and de Boer , R. 2004 . Pharmaceuticals in Australia: developments in regulation and governance . Social science and medicine , 58 : 2397 – 2407 . doi: 10.1016/j.socscimed.2003.09.012
   PubMed Web of Science ®Google Scholar
• Majone , G. 1996 . Regulating Europe , London : Routledge .
   Google Scholar
• Marks , H.M. 1997 . The progress of experiment: science and therapeutic reform in the US, 1900–1990 , Cambridge : Cambridge University Press .
   Google Scholar
• Marshall , T.H. 1949 . “ Citizenship and social class ” . In Citizenship and social class , Edited by: Marshall , T.H. and Bottomore , T.B. London : Pluto .
   Google Scholar
• Marshall , T.H. 1981 . The right to welfare and other essays , London : Heinemann .
   Google Scholar
• McCrea , B. and Markle , G.E. 1984 . The estrogen replacement controversy in the US and the UK . Social studies of science , 14 : 1 – 26 . doi: 10.1177/030631284014001002
   Web of Science ®Google Scholar
• Medicines in Europe Forum (MiEF) , 2004 . The draft regulation on conditional marketing authorization for medicinal products puts patients at risk . Available from: http://www.prescrire.org/aLaUne/dossierEuropeAMMconditionnelleEn.php [Accessed 13 May 2005] .
   Google Scholar
• Mitka , M. 2003 . Acclererated approval scrutinized – confirmatory phase 4 studies on new drugs languidh . Journal of the American Medical Association , 289 : 3227 – 3229 . doi: 10.1001/jama.289.24.3227
   Web of Science ®Google Scholar
• Patients' Coalition , 1996 . Issues of Concern to Patients in the Debate over FDA Reform , 20 March .
   Google Scholar
• Patients' Coalition , 1997 . Testimony by Jeff Bloom for the Patients' Coalition before the Committee on Commerce and Sub-Committee on Health and the Environment , United States House of Representatives , 23 April .
   Google Scholar
• Perhac , R.M. 1998 . Comparative risk assessment: where does the public fit in? . Science, technology and human values , 23 : 221 – 241 . doi: 10.1177/016224399802300204
   Web of Science ®Google Scholar
• Roberts , T.G. and Chabner , B.A. 2004 . Beyond fast track for drug approvals . New England journal of medicine , 351 : 501 – 505 . doi: 10.1056/NEJMsb040064
   Web of Science ®Google Scholar
• Sauer , F. 1997 . A new and fast drug approval system in Europe . Drug information journal , 31 : 1 – 6 . doi: 10.1177/009286159703100101
   Google Scholar
• Smith , S.R. and Kirking , D.M. 1999 . Social norms and the evolution of drug regulation in the US: implications for access to medications for HIV disease . AIDS and public policy journal , 14 : 105 – 116 .
   Google Scholar
• Temple , R. , 2003 . Cited in transcript of FDA Oncologic Drugs Advisory Committee , 74th Meeting , 12 March , 49 .
   Google Scholar
• Turner , B. 1990 . Outline of a theory of citizenship . Sociology , 24 : 189 – 217 . doi: 10.1177/0038038590024002002
   Google Scholar
• Vos , R. 1991 . Drugs looking for diseases , Lancaster : Kluwer Academic .
   Google Scholar
• Willman , D. , 2000 . How a new policy led to seven deadly drugs . Los Angeles Times , Wednesday, 20 December .
   Google Scholar