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Posted 4 March 2024 PM
The TGA is stepping up its battle against off-label use of Novo Nordisk's diabetes drug Ozempic, raiding a pharmacy accused of manufacturing semaglutide illegally.
Last Friday the TGA raided a Melbourne pharmacy in South Yarra, seizing goods and records as part of an ongoing investigation into the alleged unlawful manufacture, supply, and export of therapeutic goods including prescription medicines.
A search warrant, jointly executed by the TGA, the Victorian Department of Health and the Victorian Pharmacy Authority, uncovered a "large amount" of medication including semaglutide, peptides, and human growth hormones, which it will be alleged had been unlawfully manufactured.
The regulator said it held serious concerns around the safety and efficacy of the medication if it were to be dispensed to the public.
TGA head, Professor Anthony Lawler, warned there were serious consequences for those who break the law with respect to the import, manufacture, advertising, supply or export of therapeutic goods.
"It is important that pharmacists understand that they are most likely breaking the law if they are manufacturing or supplying medicines prior to receiving a prescription, except in very limited circumstances," he said.
"Individuals and businesses, including pharmacists and pharmacies, must understand and comply with their legal obligations under the Therapeutic Goods Act."
"Consumers need to understand that the safety of compounded medicines are not assessed by the TGA, and they are not subject to the same controls over the quality or efficacy of the goods when compared with medicines approved for supply in Australia."
The raid follows the announcement that the TGA has begun a targeted consultation as part of a proposal to remove all medicines containing GLP-1 receptor agonist analogues (GLP-1 RAs) from the pharmacist extemporaneous compounding exemptions.
In January the TGA met with state and territory Chief Health Officers and Chief Pharmacists, and the Australian Health Practitioner Regulation Agency to discuss the issue. There was unanimous agreement that the current regulatory arrangements around compounded medicines should be strengthened, and broad support expressed for a national approach to restrict compounding of medicines containing GLP-1 RAs.
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| Compounded semaglutide seized by TGA |
There has already been pushback, with the national peak body representing healthcare consumers, Consumers Health Forum of Australia (CHF), saying the government needs to do more to ensure access to Ozempic.
"What we are hearing from consumers is that ever since Ozempic has become better known as a rapid weight loss drug for celebrities, suddenly people living with conditions, like diabetes, who need the drug for medical purposes can't get it," CHF CEO, Dr Elizabeth Deveny, said. "For some it's almost like their supply has dried up overnight."
Due to the high demand Ozempic has been in shortage since May 2022, although it still earned $226.7 million pre-rebate on the R/PBS for the calendar year 2023.
The CHF has urged the Federal Government to work with state and territory governments to harmonise standards which audit and review compounding pharmacy services, and to continue efforts to import more Ozempic into Australia.
Further, it wants a roundtable of consumers, industry, and clinicians to be convened to work together to find solutions to the issues arising from the supply and use of semaglutide.
Novo Nordisk has previously raised concerns about pharmacies compounding its diabetes and weight loss medications and has gone so far as to sue pharmacies in the United States for the practice.
The stakes were raised at the end of last year when Woolies-backed telehealth company Eucalyptus said it would start selling semaglutide products from compounding pharmacies rather than through Novo Nordisk.
James Quintana Pearce
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