Researchers are suggesting the introduction of tougher investigations into off-label marketing practices by pharma companies, as the current system seems to be largely picking up only those cases with the most visible promotional activities.
The analysis, published in the journal PLOS Medicine, suggests that the UK’s self-regulatory approach, overseen by the Prescription Medicines Code of Practice Authority, is not as capable at identifying more complex, covert illegal marketing cases as the system used in the US, where enforcement actions against companies can also be brought by federal and state prosecutors and private citizens, as well as the Food and Drug Administration.
The study, by Shai Mulinari and colleagues at Lund University, Sweden, and King's College London, looked at 74 off-label promotion rulings made by the PMCPA between 2003 and 2012, and found that they typically related to only one or a few claims made in printed material. Across the pond, however, several complaints were centred on more complex, multifaceted and covert marketing activities.
In the UK, the system for exposing marketing violations mostly relies on complaints from company outsiders, in direct contrast to in the US, where Department of Justice investigations and whistleblower testimony have alleged off-label marketing campaigns that remain concealed to company outsiders, the researchers note.
They conclude that UK authorities should consider introducing “increased incentives and protections for whistleblowers combined with US-style governmental investigations and meaningful sanctions”. They also note that UK prescribers should be attentive to, and increasingly report, any incidences of off-label promotion.
The PMCPA says that it is still assessing the study, but in a statement its director Heather Simmonds commented: “The PMCPA expects and welcomes scrutiny and the detailed published reports are available for anyone to review and are a powerful sanction when breaches are ruled. The self-regulatory system deals with complaints quickly (the average in 2014 was less than 12 weeks).
"The aim of the Code is to ensure that promotion (and other activities) are carried out within a robust framework to support high quality patient care. The Code clearly prohibits the promotion of a medicine or an indication prior to receipt of the necessary marketing authorization. The PMCPA has issued detailed guidance on these requirements. If anyone – health professional, employee, member of the public, media organisation – has concerns that a company might be in breach of the Code they are invited to submit a complaint to us”.
Commenting on the comparisons between US and UK data in the study, the PMCPA added: "It is important to note the authors’ caveat in their press release: 'The study describes PMCPA rulings and whistle-blower initiated US cases, and therefore provides an incomplete view of off-label marketing in the UK and US'. This should be borne in mind when considering the full picture.
"The study does not reflect the difference in the healthcare systems or that the regulatory regime in the UK is different from the US. Also while the ABPI Code relies on complaints to be made, the PMCPA can take up media reports and other public criticisms as complaints.
"The study does not appear to compare like with like in terms of complaints mechanisms, time periods or legislation. PMCPA rulings are cited between 2003 and 2012, and the US whistle-blower initiated cases between 1996 and 2010, with reference made to settled cases through June 2015."