title: Desperately seeking cancer drugs: explaining the emergence and outcomes of accelerated pharmaceutical regulation.
abstract: Government regulators have increasingly accelerated new cancer drugs on to the market by granting them approval based on less clinical data supporting drug efficacy than permitted under standard regulations. With more lenient regulatory standards, pharmaceutical companies have keenly sought to develop cancer drugs. Focusing on the US, this article examines how the emergence and implementation of such accelerated approvals should be understood, particularly in relation to corporate bias and disease-politics theories. Drawing on longitudinal and case study data analysis, it is argued that the emergence of accelerated approval regulations for cancer drugs should be regarded primarily as part of a deregulatory regime driven by the interests of the pharmaceutical industry in partnership with all major aspects of the state, rather than as a response to patient activism in the aftermath of AIDS. Furthermore, even in cases when some patients successfully demand accelerated marketing approval of cancer drugs, such approval by regulators, while in manufacturers' interests, may not be in the interests of patients' health because the political culture of the regulatory agency is reluctant to uphold its own techno-regulatory standards of public-health protection when that would challenge the agenda-setting influence of manufacturers, including industry collaborations with patients and the medical profession.
authors.affiliation: Department of Sociology, Centre for Research in Health and Medicine (CRHaM), University of Sussex, Brighton. C.M.Davis@sussex.ac.uk
authors.forename: Courtney
authors.initials: C
authors.lastname: Davis
authors.forename: John
authors.initials: J
authors.lastname: Abraham
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy / Q000523:psychology; D019380:Anti-HIV Agents / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy / Q000523:psychology; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D055808:Drug Discovery / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000523:psychology; D011057:Politics; D011799:Quinazolines / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000458:organization & administration*
chemical_list: D019380:Anti-HIV Agents; D000970:Antineoplastic Agents; D011799:Quinazolines; D000077156:Gefitinib