Opioid marketing scrutinised by TGA, questioned by RACGP

RACGP President Dr Harry Nespolon last week wrote to Mundipharma – the Australian arm of US opioid giant Purdue Pharma – calling for a controversial brochure promoting the strong opioid Targin to be withdrawn due to claims it made about RACGP clinical recommendations.
 
The letter comes after Senator Michaela Cash recently confirmed in Parliament that the Therapeutic Goods Administration (TGA) would investigate the matter.
 
Asked by Centre Alliance Senator Stirling Griff whether the Government would close what he dubbed a loophole allowing misleading marketing material aimed at GPs, Senator Cash said that if such a loophole were discovered, the Federal Health Minister would ‘take the appropriate action’.
 
A Department of Health (DoH) spokesperson told newsGP that the TGA is now evaluating whether the Targin promotional material is compliant with the Medicines Australia Code of Conduct.
 
‘The TGA has received relevant information from Mundipharma and is currently evaluating to ascertain compliance with this requirement,’ the spokesperson said.
 
‘Failing to comply with a condition of registration can result in cancellation of the product from the ARTG [Australian Register of Therapeutic Goods]. There are also criminal and civil penalties for failing to comply with conditions.’  
 
Mundipharma is not a member of the self-regulatory industry body Medicines Australia and thus does not have to adhere to its code of conduct overseeing promotional material aimed at doctors.
 
However, the DoH spokesperson said non-members are still expected to comply with the code.
 
‘It is expected that all medicines sponsors engage constructively with the self-regulatory framework around promotion of products to medical practitioners,’ the spokesperson said. ‘The requirement for non-members to comply is made clear to companies by imposing a formal condition on the registration of each new prescription medicine requiring promotional materials to comply with the Medicines Australia Code of Conduct.’
 
A Mundipharma spokesperson told newsGP that, contrary to media reports, the marketing pamphlet in question had already been withdrawn after being circulated between August 2017 and June 2018. 
 
‘The brochure accurately represented the most relevant, current guidelines in use at the time of its publication and circulation, and consequently is not false or deceptive and did not misrepresent the RACGP’s recommendations,’ they said.
 
‘The 2009 guidelines were not superseded until July 2018, which is after the date the brochure was withdrawn from circulation. Consequently, the 2009 guidelines cited in the brochure were in fact current for the entire period in which the brochure was in circulation.’ 


RACGP President Dr Harry Nespolon wrote to Mundipharma calling for a brochure promoting the opioid Targin to be withdrawn due to claims made about RACGP clinical recommendations.

Chair of the RACGP Expert Committee – Quality Care Associate Professor Mark Morgan said that while it is true the leaflet was pulled before the 2018 RACGP Guideline for the management of knee and hip osteoarthritis was launched, the evidence on which that updated resource was based was ‘available at the time that leaflet was being circulated’.
 
The RACGP first complained about the Targin marketing in April 2018, while the Faculty of Pain Medicine also claimed the material misrepresented its position on opioids and osteoarthritis.
 
An ABC investigation came after GP and addiction physician Dr Simon Holliday complained to Medicines Australia in early 2018.
 
Medicines Australia invited Mundipharma to have Dr Holliday’s complaint heard through their Code of Conduct Committee.
 
In a March 2018 response seen by newsGP, Mundipharma Australia and New Zealand managing director Jane Orr declined that option, stating ‘Current pain guidelines are supportive of opioid use for [chronic non-cancer pain] … as part of a multimodal plan and careful approach’.
 
Public health associate professor Ken Harvey, who is also President of Friends of Science in Medicine, told newsGP that the ‘glaring loophole’ allowing pharma companies to opt out of self-regulation is a longstanding issue.
 
‘[Opioids] are an area where the industry should be extremely reluctant to have any promotion at all, because of the concerns we have,’ he said.
 
‘Self-regulation doesn’t work. It’s a touch better than no regulation, but the fact that the system has loopholes to let companies escape codes of conduct and independent investigations of complaints and no penalties – that’s crazy stuff.
 
‘Why would [pharma companies] sign up to pay money to Medicines Australia to get more constraints on what they can do?’
 
Associate Professor Harvey recently wrote to Federal Health Minister Greg Hunt, calling for a sector-wide change.
 
‘I understand that Mundipharma has now declined to have three complaints heard by [Medicines Australia],’ he wrote in the letter sighted by newsGP. ‘Friends of Science in Medicine believe it is now time for your government to make compliance with self-regulatory Codes of Conduct (and their complaint procedures) a condition of market authorisation of therapeutic goods.’
 
Mundipharma’s US parent company, Purdue Pharma, is facing lawsuits from a number of American states over allegations that the company downplayed the risk of addiction from its potent prescription opioid OxyContin.

marketing opioids TGA therapeutic goods administration