The Ozempic effect: how one drug reshaped health, hype and regulation in Australia

Semaglutide is a prescription medication approved by the Therapeutic Goods Administration (TGA) to treat type 2 diabetes mellitus (T2DM) and is a peptide similar to the hormone glucagon-like peptide 1(GLP-1.) In Australia, the best-known semaglutide medication is Ozempic, with others including Wegovy and Rybelsus. For the purposes of this article, we’ll refer to semaglutide-based medications as Ozempic. 

When Ozempic was first available on the Pharmaceutical Benefits Scheme (PBS) in July 2020, it quickly gained traction for its effectiveness in helping people with T2DM manage their condition. But popularity and demand soon outpaced expectations – and not just among diabetes patients.

Many people who were not necessarily diagnosed with T2DM, began using Ozempic for its now well-known side effect of achieving rapid weight-loss. Though not approved for this purpose in Australia, off-label use for weight management soared, with Ozempic dubbed a ‘miracle drug’ in social media and celebrity circles^[2].

The manufacturer, NovoNordisk, confirmed that the global shortage was ‘largely the result of off-label prescribing for weight loss’. 

Off-label use refers to prescribing a medicine for ‘an indication, at a dose, via a route of administration, or in a patient group that is not included in the product information approved by the TGA’^[3]. While this practice is legal and common in some clinical contexts, it can present ethical and regulatory challenges when taken up on a mass scale.

Despite not being subsided under the PBS for weight loss – and costing upwards of $150 per month – Ozempic’s reputation grew quickly through word of mouth, viral social media moments and celebrity endorsements. By 2023, it had become a household name, with widespread demand that far exceeded its original clinical intent. 

This surge in popularity put to the test the limits of the TGA’s existing frameworks regulating prescription medicines, particularly in managing off-label use and the spread of information around prescription medicines. Ozempic wasn’t just a treatment – it had become a trend. 

Under the Therapeutic Goods Act 1989(Act)^[4]the advertising of prescription medicines such as Ozempic is prohibited in Australia. This ban is broad and covers everything from sponsored testimonials to social media influencers endorsements and is designed to prevent people from self-diagnosing the suitability of medications or treatments and creating an inappropriate demand for prescription medicines.

In theory, it’s a sound public health policy. But in practice, it wasn’t built for the social media age. 

By February 2023, the hashtag #ozempicweightloss had over 170 million ‘views’ on TikTok. Influencers, celebrities and online forums amplified Ozempic’s weight loss benefits to a global audience. Australian regulators, despite issuing multiple warnings, had limited ability to enforce the ban, especially when content originated overseas. Policing an influencer from the United States, for example, was next to impossible, though the TGA’s steady stream of media releases showed a determined effort to push back. 

While social media helped fuel Ozempic’s popularity, the real harm was hidden in a blind spot: the TGA has no authority to restrict off-label prescribing, even when that demand contributes to nationwide shortages.

‘[the TGA] do not have the power to regulate the clinical decisions of health professionals and are unable to prevent doctors from using their clinical judgement to prescribe medicines for other health conditions’^[5].

Ozempic is intended for use in T2DM patients; however, the Act does not give the TGA any powers to regulate ‘clinical practice’ of individual doctors. Doctors are expected to use their clinical judgement to prescribe medicines that meet the individual needs of their patients – even if the use isn’t listed on the product’s official label.

But the sheer scale of off-label prescribing in the case of Ozempic was unprecedented.

With 66% of Australian adults classified as overweight or obese (in 2022), the demand for a rapid and effective weight loss drug was always going to be high. Between January 2021 and January 2022, the number of PBS semaglutide prescriptions issued jumped by nearly 433%, from 15,085 to 80,357^[6] indicating that the number of off-label or non-PBS prescriptions written were much, much higher. 

In September 2023, the Royal Australian College of General Practitioners (RACGP) released an alert recommending that doctors avoid starting new patients on Ozempic due to limited supply. But this wasn’t a directive – just a practical suggestion with no mechanism to control clinical use when stock runs low. 

Off-label prescribing of Ozempic in the face of drastic supply shortages raises difficult questions. In a shortage, should some uses take priority over others? Should a person clinically diagnosed with T2DM be guaranteed access before someone using Ozempic to manage weight? And who gets to decide? 

An important and relevant consideration, however, is the far-reaching and still unknown consequences for doctors, pharmacists and the general public that have arisen from the medication shortage. 

Compounding pharmacies and counterfeit Ozempic

As demand for Ozempic outpaced supply in 2023, a grey market quickly emerged. 

Medical practices began receiving unsolicited faxes and emails promoting the sale of Ozempic through certain compounding pharmacies – some legitimate and others less so. As Ozempic's popularity surged and supply dwindled, many compounding pharmacies began mass-producing imitations of the drug. While is legal when conducted by licensed pharmacists, the compounded products are not subject to the same regulatory oversight as traditionally manufactured medications. This created a loophole that some operators were quick to exploit. 

In some cases, overseas or unregulated pharmacies began mass-producing semaglutide imitations under questionable conditions, with some of these pharmacies running unchecked, in unsanitary and uncontrolled environments leading to significant safety risks to consumers.

Ironically, where Ozempic was designed to improving public health soon became associated with rising reports of adverse health outcomes relating to the medication rose sharply in connection with the increased availability of compounded or counterfeit versions of Ozempic. This raised serious liability concerns for prescribers, especially where doctors are re-directing patients to compounding pharmacies being advertised within clinics. 

In response, the Albanese Government moved to close the gap: as of October 2024, Ozempic was removed from the pharmacy compounding exemption^[7], banning domestic compounding of Ozempic products. But demand didn’t disappear – and counterfeit imports continued, with the TGA intercepting the latest batch in April 2025. 

As supply stabilises, and more alternative medications become available,^[8] regulators hope the prevalence of counterfeit Ozempic will decrease. 

Public trust in healthcare 

For thousands of Australians, particularly those with T2DM who had achieved stable blood glucose control on Ozempic, the shortage was more than a supply issue – it was a health crisis. 

With little warning, many were forced to switch to alternative medications at short notice. Some experienced fluctuations in glycaemic control, increased side effects or even hospitalisation. Others simply couldn’t access an affordable alternative. For patients using Ozempic for weight management, sudden cessation often led to rapid weight regain and mental health impacts^[9].

These treatment disruptions not only worsened clinical outcomes but also created distress and uncertainty for patients accustomed to consistent and effective therapy. Even Where a clinical solution was available, it often came at a higher cost. The TGA reported that only 0.5% of patients experience no financial impact during periods of shortage. 

This perceived unfairness added to public frustration. Many questioned why a critical diabetes medication continued to be prescribed for off-label use during a known shortage – particularly in regional and remote areas where access was already limited. This disparity eroded public trust in not just the system, but its ability to protect those most in need. 

Broader impact

The ripple effect extended beyond patients – the scarcity of Ozempic also impacted doctors, pharmacists and, in a sense, all Australians. General practitioners and faced longer consultations to find and then monitor alternative treatments, which became increasingly difficult as substitutes became unavailable. 

Pharmacies faced increased administrative burdens managing limited stock and sourcing alternatives. The shift to substitute medicines also drove up costs for the taxpayer-funded PBS, as the only available substitutes were often less cost-effective options.

While supply has since stabilised, is hoped a sense of normality can return to those who relied upon Ozempic for whichever clinical purpose they were prescribed – however, the risk of another shortage remains. Without stronger safeguards to manage demand and monitor prescribing trends, particularly for off-label use, the cycle could repeat. 

Peak industry bodies, including the Australian Medical Association, have been vocal about the scale and consequences of the Ozempic shortage, and the risk it could happen again if no action is taken. 

In response, the TGA has launched a review of its regulatory framework, focusing on two key areas:

• monitoring off-label prescribing trends, and
• how to improve transparency across medicine supply chains.

These are important steps. Earlier notice of shortages and better visibility of demand can help prescribers and pharmacists plan ahead. But transparency alone won’t solve the root cause of the issue – widespread overprescribing driven by social and digital trends, not clinical need.

The critical supply shortage of Ozempic has already had severe flow-on effects across the sector. Other GLP-1 agonist medications, such as dulaglutide (Trulicity) and liraglutide (Saxenda) also became difficult to source, affecting both diabetes and obesity treatment pathways. And the rising popularity of injectable weight-loss drugs shows no signs of slowing down. 

This brings us back to a difficult, but familiar ethical question: how can regulators balance the public health need to protect medicine supply with clinical independence of doctors to prescribe as they see fit? 

In today’s globally connected, influencer-driven health landscape, traditional controls, like advertising bans, are no longer enough. But giving regulators the power to restrict off-label prescribing raises its own risks. For patients with T2DM who rely on medications like Ozempic, blanket restrictions could cause more harm than good. 

As the TGA considers reform, any future framework must find the balance between:

• protecting clinically essential access;
• addressing inappropriate demand; and
• supporting informed, independent clinical decision-making. 

The Ozempic shortage wasn’t just a supply problem. It was a system stress test – one that exposed vulnerabilities across policy, practice and public trust. What happens next will shape how we prepare for the next wave of high-demand therapeutics, and how we protect both health outcomes and healthcare equity in the process. 

This article was prepared with the assistance of Kurt Frampton, Law Graduate.

[1] See Therapeutic Goods Administration (TGA) announcement: Ozempic (semaglutide) supply information, 18 July 2025. 

[2] Ryan N, Savulescu J, The Ethics of Ozempic and Wegovy Journal of Medical Ethics.

[3] Bell S and Richards G, ‘Off-label medicine use: Ethics, practice and future directions’ (2021) Australia Journal of General Practice 50(5).

[4] Supplemented by the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021. 

[5] TGA, ‘Ozempic (semaglutide) supply information’ Web Page.

[6] Phakey S and Shen A, ‘Impact of semaglutide and dulaglutide shortages on Pharmaceutical Benefits Scheme prescriptions supplied for type 2 diabetes treatment’ (2024) Australian Journal of General Practice 53(1-2).

[7] Medications need an exemption to be lawfully compounded. 

[8] Wegovy is available on the PBS for ‘chronic weight management’, whereas Ozempic is still only indicated for T2DM. 

[9] TGA, ‘Understanding the impacts of medicine shortages in Australia’ (April 2024) Discovery Report.