Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003-2012

PLoS Medicine
Andreas VilhelmssonShai Mulinari

Abstract

European Union law prohibits companies from marketing drugs off-label. In the United Kingdom--as in some other European countries, but unlike the United States--industry self-regulatory bodies are tasked with supervising compliance with marketing rules. The objectives of this study were to (1) characterize off-label promotion rulings in the UK compared to the whistleblower-initiated cases in the US and (2) shed light on the UK self-regulatory mechanism for detecting, deterring, and sanctioning off-label promotion. We conducted structured reviews of rulings by the UK self-regulatory authority, the Prescription Medicines Code of Practice Authority (PMCPA), between 2003 and 2012. There were 74 off-label promotion rulings involving 43 companies and 65 drugs. Nineteen companies were ruled in breach more than once, and ten companies were ruled in breach three or more times over the 10-y period. Drawing on a typology previously developed to analyse US whistleblower complaints, we coded and analysed the apparent strategic goals of each off-label marketing scheme and the practices consistent with those alleged goals. 50% of rulings cited efforts to expand drug use to unapproved indications, and 39% and 38% cited efforts to expand beyond...Continue Reading

References

Feb 3, 1990·BMJ : British Medical Journal·A Herxheimer, J Collier
Aug 28, 1997·The New England Journal of Medicine·H M ConnollyH V Schaff
Dec 31, 1997·The New England Journal of Medicine·P D Thompson
Jul 29, 2000·BMJ : British Medical Journal·A Ferriman
Dec 19, 2002·Annals of Oncology : Official Journal of the European Society for Medical Oncology·S ConroyS Gudka
May 10, 2006·Archives of Internal Medicine·David C RadleyRandall S Stafford
Aug 16, 2006·Annals of Internal Medicine·Michael A SteinmanC Seth Landefeld
Apr 26, 2007·PLoS Medicine·Michael A SteinmanLisa A Bero
Dec 18, 2007·Annals of Oncology : Official Journal of the European Society for Medical Oncology·P G Casali, UNKNOWN Executive Committee of ESMO
Apr 17, 2008·JAMA : the Journal of the American Medical Association·Joseph S RossHarlan M Krumholz
Aug 9, 2008·Nature Biotechnology·Mark Ratner, Trisha Gura
Oct 15, 2008·Pharmacological Research : the Official Journal of the Italian Pharmacological Society·Antje NeubertAdriana Ceci
Oct 31, 2008·PLoS Medicine·Adriane Fugh-Berman, Douglas Melnick
Nov 18, 2008·The Lancet Oncology·Dominique Levêque
Nov 26, 2008·Pharmacotherapy·Surrey M WaltonRandall S Stafford
Jan 9, 2009·The New England Journal of Medicine·C Seth Landefeld, Michael A Steinman
Apr 10, 2009·The New England Journal of Medicine·Michelle M MelloTroyen A Brennan
May 14, 2010·The New England Journal of Medicine·Aaron S KesselheimMichelle M Mello
Apr 20, 2011·Annals of Internal Medicine·Veronica YankRandall S Stafford
Aug 31, 2011·The Lancet Oncology
Oct 13, 2011·BMJ : British Medical Journal·Andrew Jack
Dec 8, 2011·Health Affairs·Aaron S KesselheimJerry Avorn
Dec 14, 2011·The International Journal of Risk & Safety in Medicine·Joel Lexchin, Jillian Clare Kohler
Nov 24, 2012·Palliative Medicine·Joseph CulshawAndrew Wilcock
Dec 18, 2012·BMJ : British Medical Journal·Peter C Gøtzsche
Jan 9, 2013·Nature Medicine·Susan Matthews
Feb 8, 2013·BMJ : British Medical Journal·Courtney Davis, John Abraham
Jul 23, 2014·Therapeutics and Clinical Risk Management·Christian Lenk, Gunnar Duttge
Nov 1, 2014·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·H LiF Xie

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Citations

Feb 26, 2016·Journal of Public Health Policy·Shai Mulinari
Mar 1, 2019·Investigative Ophthalmology & Visual Science·Lyndon JonesSerge Resnikoff
May 28, 2019·BMJ : British Medical Journal·Piotr OzieranskiShai Mulinari
Oct 5, 2017·Journal of Public Health·Andreas Vilhelmsson, Shai Mulinari
Oct 19, 2019·British Journal of Clinical Pharmacology·Reecha SofatR E Ferner
Sep 1, 2016·Therapeutic Innovation & Regulatory Science·Dominick AlbanoSudeep Mavila

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