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TGA threatens illegal semaglutide promoters with jail, $1m fines


Matt Woodley


2/12/2022 4:54:23 PM

Advertisers and social media influencers have been warned against publicly spruiking the drug for the purposes of weight loss.

Semaglutide injector.
The semaglutide shortage has been caused by unprecedented demand, in part due to social media influencers spruiking its weight loss benefits.

The Therapeutic Goods Administration (TGA) has reminded prospective semaglutide (sold as Ozempic) promoters of the penalties in place for those found to be violating Australia’s strict pharmaceutical advertising restrictions.
 
The notice, which specifically mentions social media influencers, warns advertisers against publicly promoting the drug for weight loss and threatens potential hefty fines and jail time for people caught breaching the Therapeutic Goods Act 1989.
 
Ozempic is a prescription-only medicine and cannot be advertised to the public,’ the notice states.
 
‘Prescription medicines are higher risk medicines and should only be determined as an appropriate treatment option in consultation with a professionally trained medical practitioner, rather than on the basis of consumer advertising.’
 
In addition to imprisonment, the TGA references criminal penalties of up to $888,000 for individuals and $4.44 million for corporations, and civil penalties of up to $1.11 million for individuals and $11.1 million for corporations.
 
Semaglutide is only indicated in Australia for the treatment of type 2 diabetes and has been in short supply since April, with stocks unlikely to return until at least the end of March 2023.
 
The drug’s shortage, which its sponsor Novo Nordisk has attributed to unprecedented demand caused in part by social media influencers spruiking its weight loss benefits, has also had a flow on effect and impacted the supply of rival GLP-1 RA medication dulaglutide, impacting patient care.
 
The TGA notice pointed out that penalties can also be applied to people advertising any medicine for an off-label use.
 
‘It is therefore illegal to advertise Ozempic for weight loss, not only because it is a prescription medicine, but because this is an off-label use of the medicine which is only indicated for the treatment of type 2 diabetes,’ it states.  
 
‘The TGA will take action in relation to illegal advertising of these products, including online advertising on social media platforms.’
 
However, while TikTok users have received much of the blame, a 2021 US FDA ruling that allowed its use as a weight loss medication (under the trade name Wegovy) has also contributed to the unexpected demand.
 
Novo Nordisk has committed to making all Wegovy dose strengths available in the US by the end of 2022, despite Australian type 2 diabetes patients being forced to go without for the next few months.
 
Dr Gary Deed, Chair of RACGP Specific Interests Diabetes, previously told newsGP the shortage is a good trigger for GPs to review the college’s type 2 diabetes guidelines.
 
‘Both diabetes and obesity management require a multimodal and multidisciplinary approach to optimising patient outcomes,’ he said.
 
‘These drug supply issues are a great opportunity to have patient management reviews, emphasise principles around healthy lifestyle, and review therapies including prescribing options or even de-prescribing if possible.’
 
Alternative treatment options suggested by the RACGP include:  

The twice daily exenatide (Byetta) is not recommended as a potential substitute, as it has been discontinued and is also no longer available.
 
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diabetes dulaglutide Ozempic semaglutide TGA Therapeutic Goods Administration Trulicity Wegovy


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