TGA Battles Unsafe and Counterfeit Products

Several recent product safety challenges have arisen in the Australian pharmaceutical market and have led to a variety of regulatory actions. In general, the Therapeutic Goods Administration (TGA) frequently exercises its wide-ranging enforcement powers. However, in these instances, the TGA seems to be responding to unique or specific incidents.

Overall, product safety regulators in Australia often prefer a reactive approach to enforcement actions. The cases outlined here demonstrate the breadth and depth of powers the TGA has at its disposal.

Unsafe products

Based on post-market surveillance inquires and international regulatory enforcement actions, the TGA has taken a number of steps to address safety concerns, including issuing warnings and implementing product restrictions and bans.

Sodium valproate

Due to a suggested association with birth defects and developmental disorders during pregnancy, the epilepsy and bipolar medication sodium valproate is currently under further review by the TGA. European studies have also recently shown that the drug poses a potential risk of neurodevelopmental disorders in children of fathers treated with the drug, especially as compared to other similar mediations.

The TGA has not yet followed the path of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and restricted the use of the product. However, the current inquiry heightens debates about how to regulate it in Australia. The issue poses a difficult ethical conundrum and has drawn particularly divergent views. At issue is that the health of the parents may be compromised if they need the medication to control epilepsy or a bipolar disorder. However, reproductive rights could also be compromised due to efforts to minimize the exposure to infants and children. In the interim, the TGA issued a series of recommendations in November 2024 to mitigate the possible risks from the use of these products.

Ziyinzhuangyang tablets

On 28 November 2024, the TGA issued a safety warning for Ziyinzhuangyang tablets, which are used to treat erectile dysfunction (ED). These products contain unmarked ingredients, including sildenafil, an ingredient in a popular brand name ED treatment that is only available in Australia by prescription. Safety concerns include dangerous interactions with heart medications that could lead to increased risks of cardiovascular events such as stroke or heart attack.

The TGA warned consumers to avoid purchasing this medication from unregulated online sources. In particular, the TGA advises consumers to exercise extreme caution when purchasing medicines from overseas websites because products may be fake, contain incorrect or undisclosed harmful ingredients, or generally not meet the same standards of quality, safety, and efficacy as products manufactured in Australia under the oversight of the TGA.

Counterfeit semaglutide products

Safety risks from counterfeit products continue to be a prominent issue in the Australian market. This is particularly problematic in light of shortages for popular semaglutide and other glucagon-like peptide-1 (GLP-1) drugs used for weight loss and to treat diabetes. Counterfeit versions of one common branded GLP-1 are being circulated widely in the market.

Severe safety risks have been reported with the counterfeit versions, including hypoglycaemia, allergic reactions, and a number of hospitalisations. The TGA has received one report of a life-threatening adverse event in which a product purchased overseas contained insulin, which is a different type of medicine than the GLP-1 entirely and can result in dangerously low life-threatening blood sugar levels when administered inappropriately.

Consumers and health professionals should be aware that injection pens containing the counterfeit GLP-1 labelled as an approved branded product have been imported into Australia. These fake products may pose a serious health risk and should not be used. There are clear inconsistencies from the original product to look out for, including spelling errors, instruction leaflets in non-English languages, unsealed packaging, and differences in the medicine size, shape, or appearance compared to the real drug.

The TGA lists these variances as indications that the medicine has not been produced by the original manufacturer or is being illegally sold in the wrong market. The TGA has collaborated with the Australian Border Force (ABF) to detect counterfeit branded GLP-1 drugs being imported into Australia. Laboratory testing performed by the agencies has confirmed that some products seized contained the undeclared substance insulin glulisine. It appears the products in question are relabelled insulin injection pens.

The counterfeit products appear to have been purchased online from overseas websites and imported under the personal importation scheme. Whilst permissible to lawfully import prescription medicines in this manner into Australia, the TGA has warned that it is still illegal to import counterfeit products and has urged consumers to buy from reputable sources to minimise safety risks.

The agency has issued warnings and increased enforcement against counterfeit drug imports in an attempt to address the issue at its apparent source. In addition, from 1 October 2024, Australian pharmacies have not been allowed to compound GLP-1 receptor agonists (RAs) like semaglutide.

Commentary

The TGA’s strong monitoring and action-based approach is evident in the number and range of product safety concerns it regularly identifies, the consumer warnings it issues, and the actions it takes in the Australian market. The safety and authenticity of online sales, as well as overseas and counterfeit products, remain key targets for the TGA and are areas of top concern.

Going forward, it will be interesting to see whether the TGA is able to translate these strong, but individual, enforcement actions into a more comprehensive and holistic approach to what appears to now be patterns regarding product safety issues in the pharmaceutical industry in Australia.

The most logical and effective next step may be to develop more considered policies that address these risks at their source. For example, given their apparent focus on sources of safety issues, overseas online marketplaces and import practices for pharmaceuticals seem to be a good target for more systemic change. The challenge will be addressing the actors responsible for the issues that likely reside outside Australia since the TGA does not have jurisdiction in other markets.

This article was originally published as part of the Sedgwick brand protection Australian Recall Index