TGA threatens heavy fines for promoting semaglutide

3 minute read

Anyone posting about the weight loss drug, even unpaid, could find themselves in hot water with the drugs regulator.

PBS-listed type 2 diabetes drugs will come with a hefty price tag this Christmas, both for those who use it and those who want others to use it.

The great diabetes drug shortage saga of 2022 has taken yet another turn, with the TGA putting out a “reminder” that individuals who advertise a medicine like semaglutide (Ozempic, Novo Nordisk) to the public face jail time and hefty fines.

The medicine has been in global shortage since May after it gained popularity on social media for its off-label use in weight loss.

Back-up diabetes medicine dulaglutide (Trulicity, Eli Lilly) is also now in shortage and supplies of both are not expected to return to normal until March.

In the meantime, the TGA has approved an alternative supplier to import overseas-registered semaglutide and dulaglutide products on a small scale.

PBAC has refused to list the products on the PBS because the alternate supply comes with a higher price, which it said “did not appear well justified from a cost of goods perspective”.

Drug pricing will be up to the discretion of each individual pharmacy that manages to secure some of the scarce stock, which only amounts to about 500 products per month.

The TGA warns that the overseas supply “may be considerably more expensive” as a result.

In a release today, the regulator restated the penalties associated with advertising a therapeutic good to the public.

Ozempic, the agency points out, is a therapeutic good.

Advertising can result in criminal penalties of $888,000 for individuals and $4.44 million for corporations along with jail time, or civil penalties of up to $1.11 million for individuals and $11.1 million for corporations.

The TGA’s definition of advertising is extremely broad, and captures any statement, pictorial representation or design that is intended to promote the use or supply of a regulated product.

This would appear to capture any social media posts in which consumers spruik the benefits of semaglutide for weight loss, even if that person was not paid or encouraged by a third party to make those statements.

“Even if the material or the format of advertising can be said to promote the use or supply of relevant goods only in an indirect way, the material or format will still be an ‘advertisement,’” the TGA said.

The agency has publicly blamed social media users for the shortage and encourages people to report non-compliant material like viral TikTok videos about the medicine.

Meanwhile, exenatide (Byetta, Astra Zeneca) – the only other alternative GLP-1 receptor agonist on the market – has abruptly become unavailable too.

Astra Zeneca’s plan to discontinue the drug predate the other -glutides falling into short supply, but it was originally slated to leave Australian shelves in May 2023.

The earlier-than-scheduled departure of the medicine is down to increased demand in the wake of the shortages.

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