Nav: Home

Pharmaceutical industry self-regulation of off-label drug promotion in the UK

January 26, 2016

The UK's self-regulatory approach to preventing pharmaceutical companies from promoting off-label use of their drugs detects mainly high-visibility promotional activity such as print advertising, according to a document analysis of off-label promotion rulings published this week in PLOS Medicine by Shai Mulinari and colleagues at Lund University, Sweden, and King's College London, UK. The study indicates that the UK self-regulatory approach is less capable of uncovering complex marketing campaigns than the government-led approach in the US.

In the US, the Food and Drug Administration (FDA) regulates and prosecutes off-label promotion, but legal actions against companies can also be brought by federal and state prosecutors, often following whistleblower (company insider) complaints facilitated by the False Claims Act. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has delegated this responsibility to a self-regulatory body set up by the pharmaceutical industry--the Prescription Medicines Code of Practice Authority (PMCPA). In this review of 74 off-label promotion rulings made by the PMCPA between 2003 and 2012, Mulinari and colleagues compare off-label promotion cases from the UK with whistleblower-initiated cases from the US. They find that while several US whistleblower-initiated cases alleged multifaceted and covert marketing campaigns, UK rulings described a more restricted range of promotional activities and typically referred to a single advertisement. The UK rulings cited efforts to expand drug use to unapproved indications (50%), diseases (39%) and dosing strategies (38%); competing companies lodged the majority (57%) of complaints whereas prescribers (the prime target of off-label promotion) lodged only 22% of the complaints. Almost half of the 43 violating companies were found to have promoted products off-label more than once in the UK, and about one-fourth were ruled in breach three or more times.

The study describes PMCPA rulings and whistleblower-initiated US cases, and therefore provides an incomplete view of off-label marketing in the UK and US. However, the results suggest that the UK's self-regulatory mechanism for detecting, deterring, and sanctioning off-label promotion may be inadequate. The authors state, "UK authorities should consider introducing increased incentives and protections for whistleblowers combined with US-style governmental investigations and meaningful sanctions. UK prescribers should be attentive to, and increasingly report, off-label promotion."
-end-
Research Article

Funding:

This work was supported by the Swedish Research Council, http://www.vr.se [grant 2013-1268 to SM], and Riksbankens Jubileumsfond (Bank of Sweden Tercentenary Foundation), http://www.rj.se [grant P09-0281:1-E to SM]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing Interests:

AV and CD are members of Health Action International (HAI), a non-profit organisation working to increase access to essential medicines and the rational use of medicines. HAI has undertaken work, with the WHO, on a teaching manual for medical and pharmacy students, 'Understanding and Responding to Pharmaceutical Promotion'.

Citation:

Vilhelmsson A, Davis C, Mulinari S (2016) 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 Med 13(1): e1001945. doi:10.1371/journal.pmed.1001945

Author Affiliations:

Department of Clinical Sciences, Division of Social Medicine and Global Health, Faculty of Medicine, Lund University, Lund, Sweden Department of Gender Studies, Faculty of Social Sciences, Lund University, Lund, Sweden Department of Social Science, Health and Medicine, King's College London, London, United Kingdom Department of Sociology, Faculty of Social Sciences, Lund University, Lund, Sweden

IN YOUR COVERAGE PLEASE USE THIS URL TO PROVIDE ACCESS TO THE FREELY AVAILABLE PAPER:

http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001945

Contact:



Shai Mulinari
Lund University
Department of Sociology
Box 114
221 00
Lund, 221 00
SWEDEN
+46737343316
shai.mulinari@soc.lu.se

PLOS

Related Complaints Articles:

Paying attention to complaints can protect nurses from violence
New UBC research shows, for the first time, a clear link between patient complaints and violence towards nurses.
Conversational difficulties with father affect adolescent health
Conversational difficulties with father after a divorce affects the children's health negatively.
Study questions routine troponin testing for ACS in geriatric patients with NSCs
The results of a study conducted by researchers from Indiana University School of Medicine may not support troponin testing for acute coronary syndrome (ACS) in selected elderly patients with nonspecific complaints (NCSs).
Police officers' exposure to peers accused of misconduct shapes their subsequent behavior
A new Northwestern University study investigated how Chicago police officers' exposure to peers who had been accused of misconduct shaped their involvement in subsequent excessive force cases.
The dynamics of workplace sexual harassment in the US
A new Gender, Work & Organization analysis of US data from 1997-2016 provides new insights into workplace sexual harassment.
Companies battling shareholder complaints have a potent weapon-advertising
A new study in the Journal of Marketing explores how firms can configure advertising investments to respond to shareholder complaints and limit the damage of these public battles.
Online complaint system used by Google and Twitter is like the 'Wild West'
The online complaint system used by web giants like Google and Twitter is a 'Wild West' with evidence of abuse by complainants, according to a new study from Queen Mary University of London.
Gastrointestinal complaints in children could signal future mental health problem
Columbia University researchers are among the first to link disruption of a child's gastrointestinal microbiome triggered by early-life adversity -- such as parental separation -- with activity in the regions of the brain associated with emotional health.
Specialist-led bereavement service may help curb legal action after hospital deaths
Hospital bereavement services that are led by senior doctors and nurses and the person responsible for quality and safety may help to curb patient complaints and legal action in the wake of a difficult death, suggest the results of a pilot study, carried out at one NHS hospital trust and published online in the journal BMJ Supportive & Palliative Care.
Insomnia has many faces
Researchers at the Netherlands Institute for Neuroscience revealed that there are five types of insomnia.
More Complaints News and Complaints Current Events

Trending Science News

Current Coronavirus (COVID-19) News

Top Science Podcasts

We have hand picked the top science podcasts of 2020.
Now Playing: TED Radio Hour

Listen Again: Reinvention
Change is hard, but it's also an opportunity to discover and reimagine what you thought you knew. From our economy, to music, to even ourselves–this hour TED speakers explore the power of reinvention. Guests include OK Go lead singer Damian Kulash Jr., former college gymnastics coach Valorie Kondos Field, Stockton Mayor Michael Tubbs, and entrepreneur Nick Hanauer.
Now Playing: Science for the People

#562 Superbug to Bedside
By now we're all good and scared about antibiotic resistance, one of the many things coming to get us all. But there's good news, sort of. News antibiotics are coming out! How do they get tested? What does that kind of a trial look like and how does it happen? Host Bethany Brookeshire talks with Matt McCarthy, author of "Superbugs: The Race to Stop an Epidemic", about the ins and outs of testing a new antibiotic in the hospital.
Now Playing: Radiolab

Dispatch 6: Strange Times
Covid has disrupted the most basic routines of our days and nights. But in the middle of a conversation about how to fight the virus, we find a place impervious to the stalled plans and frenetic demands of the outside world. It's a very different kind of front line, where urgent work means moving slow, and time is marked out in tiny pre-planned steps. Then, on a walk through the woods, we consider how the tempo of our lives affects our minds and discover how the beats of biology shape our bodies. This episode was produced with help from Molly Webster and Tracie Hunte. Support Radiolab today at Radiolab.org/donate.