Drug Evaluation and the Permissive Principle: Continuities and Contradictions between Standards and Practices in Antidepressant Regulation (2009)
Abraham, John (Author)
Davis, Courtney (Author)
Social Studies of Science
Volume: 39
Pages: 569--598
Pharmaceuticals are not permitted on to the market unless they are granted regulatory approval. The regulatory process is, therefore, crucial in whether or not a drug is widely prescribed. Regulatory agencies have developed standards of performance that pharmaceuticals are supposed to meet before entering the market. Regulation of technologies is often discussed by reference to the precautionary principle. In contrast, this paper develops the concept of the `permissive principle' as a way of understanding the departure of regulators' practices from standards of drug efficacy to which regulatory agencies themselves subscribe. By taking a case study of antidepressant regulation in the UK and the USA, the mechanisms of permissive regulatory practices are examined. An STS methodology of both spatial (international) and temporal comparisons of regulatory practices with regulatory standards is employed to identify the nature and extent of the permissive regulation. It is found that the permissive principle was adopted by drug regulators in the UK and the USA, but more so by the former than the latter. Evidently, permissive regulation, which favours the commercial interests of the drug manufacturer, but is contrary to the interests of patients, may penetrate to the heart of regulatory science. On the other hand, permissive regulation of specific drugs should not be regarded as an inevitable result of marketing strategies and concomitant networks deployed by powerful pharmaceutical companies, because the extent of permissive regulation may vary according to the intra-institutional normative commitments of regulators to uphold their technical standards against the commercial interests of the manufacturer. Likely sociological factors that can account for such permissive regulatory practices are `corporate bias', secrecy and excessive regulatory trust in the pharmaceutical industry in the UK, political expediency and ideological capture in the USA, combined in both countries with some regulatory deference to the clinical autonomy of the psychiatry profession.
...MoreSimilar Citations
Thesis
Hanganu-Bresch, Cristina;
(2008)
Faces of Depression: A Study of Antidepressant Advertisements in the American and British Journals of Psychiatry, 1960--2004
(/isis/citation/CBB001561430/)
Article
Abraham, John;
Davis, Courtney;
(2006)
Testing Times: The Emergence of the Practolol Disaster and Its Challenge to British Drug Regulation in the Modern Period
(/isis/citation/CBB000770617/)
Article
Sihn, Kyu-hwan;
(2013)
The Institutionalization of Pharmaceutical Administration after the Korean Liberation: Focusing on Regulating the Pharmaceutical Affairs Law (Yaksabeop) in 1953
(/isis/citation/CBB001214039/)
Article
Horwitz, Allan V.;
(2011)
Naming the Problem That Has No Name: Creating Targets for Standardized Drugs
(/isis/citation/CBB001221532/)
Article
Pieters, Toine;
Majerus, Benoît;
(2011)
The Introduction of Chlorpromazine in Belgium and the Netherlands (1951--1968); Tango between Old and New Treatment Features
(/isis/citation/CBB001221534/)
Article
McGoey, Linsey;
(2010)
Profitable Failure: Antidepressant Drugs and the Triumph of Flawed Experiments
(/isis/citation/CBB000953791/)
Article
Klöppel, Ulrike;
Balz, Viola;
(2010)
Psychopharmaka im Sozialismus. Arzneimittelregulierung in der Deutschen Demokratischen Republik in den 1960er Jahren
(/isis/citation/CBB001022054/)
Article
Koichi Mikami;
(2019)
Orphans in the Market: The History of Orphan Drug Policy
(/isis/citation/CBB788431131/)
Article
Gabriel, Joseph M.;
(2011)
Restricting the Sale of “Deadly Poisons”: Pharmacists, Drug Regulation, and Narratives of Suffering in the Gilded Age
(/isis/citation/CBB001220743/)
Chapter
Daemmrich, A.;
Greene, J.;
(2010)
From Visible Harm to Relative Risk: Centralization and Fragmentation of Pharmacovigilance
(/isis/citation/CBB001221031/)
Article
Hersch, Matthew H.;
(2008)
“Calm, But Still Alert”: Marketing Stelazine to Disturbed America, 1958--1980
(/isis/citation/CBB000932029/)
Book
Tone, Andrea;
(2009)
The Age of Anxiety: A History of America's Turbulent Affair with Tranquilizers
(/isis/citation/CBB000951137/)
Thesis
John, Heather Varughese;
(2013)
Practicing Physicians: The Intern & Resident Experience in the Shaping of American Medical Education, 1945--2003
(/isis/citation/CBB001567507/)
Article
Daemmrich, A.;
(2007)
Pharmaceutical Regulation in the United States and Europe
(/isis/citation/CBB001221028/)
Thesis
Guise-Richardson, Catherine;
(2009)
Protecting Mental Health in the Age of Anxiety: The Context of Valium's Development, Synthesis, and Discovery in the United States, to 1963
(/isis/citation/CBB001561210/)
Thesis
Metzl, Jonathan Michel;
(2001)
The Freud of Prozac: Tracing psychotropic medications through American culture, 1955-2001
(/isis/citation/CBB001562624/)
Article
Buerki, Robert A.;
(2008)
The Conscience Clause in American Pharmacy: An Historical Overview
(/isis/citation/CBB000932021/)
Article
Brushwood, David B.;
(2009)
Recent Trends in Pharmacy Law and Regulation
(/isis/citation/CBB000933447/)
Article
Fraser, Mariam;
(2001)
The nature of Prozac
(/isis/citation/CBB000101711/)
Book
Healy, David;
(2004)
Let Them Eat Prozac: The Unhealthy Relationship between the Pharmaceutical Industry and Depression
(/isis/citation/CBB000630180/)
Be the first to comment!