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TGA issues more medicinal cannabis advertising fines


Jolyon Attwooll


2/11/2022 4:22:55 PM

The infringement notices were given to two medicinal cannabis companies, the latest in a series of fines handed out by the medicines regulator.

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The TGA has described enforcing importing, advertising and supply regulations for medicinal cannabis as a ‘compliance priority’.

Two medicinal cannabis clinics have been issued fines of more than $100,000 each for alleged unlawful advertising on websites and social media.
 
The Therapeutic Goods Administration (TGA) confirmed infringement notices for two companies in a media release this week.
 
It said it had issued 10 infringement notices totalling $133,200 to Biologics Research Institute Australia, and eight notices to the Australian Institute of Medicinal Cannabis Pty (trading as MiDispensary) adding up to $106,560.
 
Both companies are registered to Sydney addresses.
 
The TGA announcement states that prescription-only medicines ‘cannot be advertised to consumers in Australia as it undermines the doctor–patient relationship and may create an inappropriate demand for particular medicines which may not be right for the individual’.
 
Businesses are only allowed to advertise such medicines to health professionals, with the advertisements not supposed to be accessible to the wider public.
 
The TGA also alleges that the advertising ‘included unapproved references to serious diseases or conditions, including cancer and epilepsy’.
 
‘Some advertising also allegedly suggested or implied that particular medicinal cannabis products were recommended or approved by a government authority,’ it stated.
 
A spokesperson for Biologics Research Institute Australia confirmed the receipt of the TGA infringement notices, and said the company is considering its course of action.
 
‘Biologics take compliance seriously and has always made every effort to work within the regulatory parameters,’ they stated.
 
The Australian Institute of Medicinal Cannabis Pty was also approached for comment by newsGP but did not respond prior to publication.
 
It follows previous TGA notices issued in September to three licensed medicinal cannabis companies for the alleged unlawful promotion of their products, with fines totalling almost $1 million.
 
The regulator said it encourages reports of non-compliant advertising, and describes its remit to enforce importing, advertising and supply requirements for medicinal cannabis as a ‘compliance priority’.
 
There has been significant growth in Australia’s medicinal cannabis program since it began in late 2016.
 
A streamlined process intended to allow GPs more flexibility in prescribing products with the same active ingredient has since been introduced.

 A detailed study of the program indicated medicinal cannabis is being prescribed more often and for a wider variety of conditions.
 
The analysis of five years of prescribing history, published in Frontiers in Pharmacology in May this year, reported a significant uptick in prescriptions with 82.4% of the total being issued since January 2020 until August 2021, when the study period concluded.
 
In 2019, the RACGP called for more research into the safety and effectiveness of medicinal cannabis products, describing evidence at the time as ‘limited and inconclusive’.
 
However, it did say there was a role for them ‘in a number of areas’ if conventional, evidence-based treatments had failed, and the GP ‘feels that medicinal cannabis products are a viable treatment option for their patients’.
 
The TGA has published guidelines for health professionals prescribing medicinal cannabis on its website.
 
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A.Prof Christopher David Hogan   9/11/2022 9:44:06 PM

The Wonder Drug Phenomenon is well known to researchers.
This occurs when an unused or novel medication appears offering hope for conditions which were previously not treatable.
After initial favourable reports it is used enthusiastically & then overused outside its indication.
Next come reports of adverse events or miserable failures outside its indications.
Its use declines significantly
Eventually common sense rears its unfashionable head & the drug is used cautiously & appropriately