Federal Government to Ban Compounded Replica Ozempic Amid Safety Concerns
The federal government will prohibit all compounding pharmacists from producing replica versions of diabetes drugs like Ozempic and Mounjaro, widely used off-label for weight loss, following a Four Corners investigation that exposed illegal manufacturing practices in Australia.
Investigation Findings
A video recorded by investigators from the Therapeutic Goods Authority (TGA) revealed that a facility in Western Sydney was producing these drugs under unsanitary conditions, using kitchen equipment and chemicals. The investigation found that these illegally manufactured drugs were being exported overseas.
Ongoing Drug Shortages
Global shortages of Ozempic are expected to continue into next year. The government has announced a four-month transition period for the industry before the ban takes effect.
Public Safety Concerns
The Four Corners investigation uncovered that a registered Australian pharmacist was running an international operation, manufacturing and exporting replica Ozempic to the United States. Patients who used medication from Total Compounding Pharmaceuticals (TCP) reported serious side effects, including nerve damage, rashes, vomiting blood, and bleeding gums, which they believe were linked to the compounded drugs.
Currently, Australian compounding pharmacists are allowed to reproduce brand-name drugs during shortages, but these replicas are not subjected to the same stringent safety checks. Federal health minister Mark Butler announced that this loophole will close in October, removing the exemption for compounding active ingredients in drugs like Ozempic.
Impact on Patients and the Industry
In Australia, an estimated 20,000 people use compounded weight loss medications, but the actual number may be higher. The TGA has already seized vials of unlawfully manufactured semaglutide from a Victorian pharmacy.
Minister Butler expressed concern that many patients using compounded versions of these drugs were unaware of the safety risks, which have also been highlighted by the FDA in the United States. He emphasized the lack of oversight in the manufacturing conditions and the ingredients used, as well as the absence of a formal system for reporting adverse events.
Filthy Manufacturing Conditions
The TGA provided footage showing the deplorable conditions in which TCP was allegedly producing replica Ozempic. The facility, filled with kitchen mixers and blenders, did not meet the standards expected for manufacturing injectable medications.
Regulatory and Industry Response
The announcement of the ban has garnered support from various health organizations, including the Pharmacy Board of Australia, Diabetes Australia, the Medical Board of Australia, and the RACGP. However, some pharmacy groups and telehealth companies, like Eucalyptus, opposed the ban, arguing it would deny thousands of Australians access to life-changing medication amid global shortages.
Addressing the Shortage
RACGP president Dr. Nicole Higgins acknowledged the shortage and the potential anxiety it might cause for patients using Ozempic off-label for weight loss. Minister Butler assured that the government is working with pharmaceutical companies to mitigate the impact of the ban. He stressed the importance of prioritizing diabetes patients for whom these drugs are approved under the PBS.
“We’ve already got a shortage of this medication for the people it was initially designed for, which is our [people with] type 2 diabetes. I expect that those shortages may be exacerbated, and it’s going to cause some anxiety for those who’ve been using Ozempic off-label,” Dr. Higgins said.
The TGA’s latest update indicates that the supply of Ozempic will remain limited throughout 2024 due to increased demand for weight loss, with Mounjaro also expected to be in short supply until at least September.
Moving Forward
Patients relying on compounded medications are advised to consult their GPs and healthcare teams for support during this transition. Minister Butler reiterated the government’s commitment to ensuring that diabetes patients have priority access to these essential medications.
The four-month transition period is intended to allow the industry to adapt while safeguarding public health by eliminating unsafe manufacturing practices.
