Therapeutic Goods Administration Research Articles

Clinical Benefit and Expedited Approval of Cancer Drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia.

PURPOSE:Regulatory agencies have sought to speed up the review of new cancer medicines and reduce delays in approval between countries. We examined trends in regulatory review times and association with clinical benefit for new cancer medicines in six jurisdictions: United States (Food and Drug Administration [FDA]), European Union (European Medicines Agency [EMA]), Switzerland (Swissmedic), Japan (Pharmaceuticals and Medical Devices Agency [PMDA]), Canada (Health Canada), and Australia (Therapeutic Goods Administration).METHODS:We studied all new cancer drugs approved in the six aforementioned jurisdictions from 2007 to 2020. We extracted all applicable expedited programs, total regulatory review times, and, for drugs first approved by the FDA, times to subsequent regulatory approval. Clinical benefit was assessed using the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale value framework and ASCO-Cancer Research Committee's targets. Nonparametric Kruskal-Wallis test was used to compare total review times for high versus low clinical benefit drugs.RESULTS:One hundred and twenty eight drugs received initial approval in at least one of the six included jurisdictions. Most drugs approved by the FDA (91%) and Health Canada (59%) qualified for at least one expedited program within those jurisdictions, compared with 46% of EMA approvals and 18% of PMDA approvals. The FDA was the first regulator to approve 102 (80%) drugs. Delays in submission accounted for a median of 20.2% (EMA) to 83.8% (PMDA) of the time to subsequent approval. There was no association between high clinical benefit and shorter total review times.CONCLUSION:Most new cancer therapies were approved first by the FDA, and delays in submission of regulatory applications accounted for substantial delays in approving cancer drugs in other countries. Regulators should prioritize faster review for drugs with high clinical benefit.

A point-prevalence study of off-label medication use in an Australian adult tertiary intensive care unit

Medications prescribed for indications or at doses, frequencies or durations not approved by the Australian Therapeutic Goods Administration are considered "off- label". Critical illness makes seeking consent for off-label medication use impractical. We aimed to characterise the extent of off-label medication use in a tertiary medical- surgical intensive care unit (ICU) by auditing the electronic health records of all patients admitted over a one-month period. We found 25.4% of 2292 prescriptions made for 142 patients were off-label. Eighty-one (37.2%) of the total of 218 different prescribed medications were used at least once for an off-label indication. Medications commonly prescribed off-label included antacids (pantoprazole, esomeprazole), analgesics (fentanyl, morphine, ketamine, pregabalin), anticonvulsants (levetiracetam), antibiotics (cefazolin, erythromycin), antipsychotics (quetiapine, haloperidol), and cardiovascular agents (metoprolol, clonidine). Nearly all patients (88.0%) received at least one off-label medication during their ICU stay. Most off- label medications were used for conventional (albeit not licensed) reasons, but nine out of 81 (11.1%) were not; for example, acetazolamide for hypertension, aminophylline for oliguria, and dexmedetomidine for seizures. Recognising the challenges of formally registering an indication with the Therapeutic Goods Administration, but also the value of reducing the incidence of medications used for potentially incorrect purposes, we suggest guideline endorsement of what constitutes standard critical care practice as an alternative to regulatory control.

Effects of a multicomponent resistance-based exercise program with protein, vitamin D and calcium supplementation on cognition in men with prostate cancer treated with ADT: secondary analysis of a 12-month randomised controlled trial

ObjectivesThe aim of this preplanned secondary analysis of a 12-month randomised controlled trial was to investigate the effects of a multicomponent exercise programme combined with daily whey protein, calcium and...

Kamini, a little recognised source of illicit opioid: A case series of 12 patients.

This case series describes 12 patients who developed opioid use disorder after ingesting a prohibited, imported herbal product, Kamini, which contains Papaver somniferum. They appeared unaware of the risk of dependence from Kamini and most had struggled to manage their use for many months before presenting for treatment. After two cases were presented at a clinical meeting, a chart review was conducted of cases across four public opioid treatment clinics in south-east Queensland with about 1500 patients registered, identifying 10 further cases. Twelve patients presented with features of opioid withdrawal, seeking treatment after use of Kamini for periods between 6months and 8 years. Eleven patients were born in India. Nine patients stabilised on buprenorphine maintenance treatment, three of whom commenced long-acting injectable buprenorphine. One patient left after 1 day and subsequently began methadone treatment with a private prescriber. Two patients on smaller doses and shorter-term use undertook withdrawal with prescribed (off-label) trans-dermal buprenorphine. One patient, initially lost to follow-up, later stabilised on long-acting injectable buprenorphine. Reasons for presenting included supply shortages and financial distress during the COVID-19 pandemic. Kamini represents an illicit source of non-prescription opioid in Australia. Although classified as an illegal import by the Therapeutic Goods Administration, patients confirm that it is readily available in Brisbane. Targeted efforts are needed to prevent further patients developing opioid dependence from use of Kamini and also to highlight treatment options for those seeking to stop Kamini use.

Medicinal Cannabis Prescribing in Australia: An Analysis of Trends Over the First Five Years.

A regulatory framework allowing legal access to medicinal cannabis (MC) products has operated in Australia since November 2016. MC prescribing by healthcare practitioners (HCPs) is primarily conducted through the Special Access Scheme - Category B (SAS-B) pathway, through which prescribers apply to the Therapeutic Goods Administration (TGA–the federal regulator) for approval to prescribe a category of product to an individual patient suffering from a specific indication. The dataset collected by the TGA provides a unique opportunity to examine MC prescribing trends over time in the Australian population. Here we analysed this TGA SAS-B dataset since inception with respect to age, gender, product type (e.g., oil, flower, etc.), CBD content, indication treated, and prescriber location. Results are presented descriptively as well as being analysed using non-linear regression models. Relationship between variables were explored via correspondence analyses. Indications were classified with reference to the International Statistical Classification of Diseases and Related Health Problems (10th Revision). As of 31 August 2021, a total of 159,665 SAS-B approvals had been issued for MC products, 82.4% of were since January 2020. Leading indications for approvals were for pain, anxiety, and sleep disorders. Oil products were the most popular product type, while CBD-dominant products (≥98% CBD) accounted for 25.1% of total approvals. Approvals for flower products increased markedly during 2020–2021, as did approvals involving younger age groups (18–31 years old), male patients, and non-CBD dominant products. A disproportionate number of SAS-B MC applications (around 50%) came from HCPs in the state of Queensland. Associations between patient gender and age and/or indication with product type were found. For example, approvals for oil products were commonly associated with approvals for pain. While, overall prescribing increased dramatically over the last 2 years of analysis, stabilization of approval numbers is evident for some indications, such as pain. Current prescribing practices do not always reflect provided TGA guidance documents for MC prescribing. While acknowledging some limitations around the SAS-B dataset, it provides a unique and valuable resource with which to better understand current prescribing practices and utilisation of MC products within Australia.

20 Years of Legislation - How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic.

•In contrast to the prior voluntary system, since 2001, gene technology in Australia has been regulated under a legislated national Gene Technology Regulatory Scheme which is administered by the Gene Technology Regulator.•The Scheme provides science-based assessment of the potential risks of gene technology to the health and safety of people and the environment.•It complements the role of the Australian Therapeutic Goods Administration which regulates all therapeutic products in Australia to ensure they are safe and effective.•Recent reforms to the Scheme contribute to, and anticipate, the continued safe development and delivery of gene-based human therapeutics in Australia as a successful model for other jurisdictions.

Recent SARS-CoV-2 infection: too early to vaccinate?

Recent SARS-CoV-2 infection: too early to vaccinate?

Initial and supplementary indication approval of new targeted cancer drugs by the FDA, EMA, Health Canada, and TGA

SummaryBackground. Previous research focused on the clinical evidence supporting new cancer drugs’ initial US Food and Drug Administration (FDA) approval. However, targeted drugs are increasingly approved for supplementary indications of unknown evidence and benefit. Objectives. To examine the clinical trial evidence supporting new targeted cancer drugs’ initial and supplementary indication approval in the US, EU, Canada, and Australia. Data and Methods. 25 cancer drugs across 100 indications were identified with FDA approval between 2009–2019. Data on regulatory approval and clinical trials were extracted from the FDA, European Medicines Agency (EMA), Health Canada (HC), Australian Therapeutic Goods Administration (TGA), and clinicaltrials.gov. Regional variations were compared with χ2-tests. Multivariate logistic regressions compared characteristics of initial and supplementary indication approvals, reporting adjusted odds ratios (AOR) with 95% confidence intervals (CI). Results. Out of 100 considered cancer indications, the FDA approved 96, the EMA 92, HC 86, and the TGA 83 (83%, p < 0.05). The FDA more frequently granted priority review, conditional approval, and orphan designations than other agencies. Initial approvals were more likely to receive conditional / accelerated approval (AOR: 2.69, 95%CI [1.07–6.77], p < 0.05), an orphan designation (AOR: 3.32, 95%CI [1.38–8.00], p < 0.01), be under priority review (AOR: 2.60, 95%CI [1.17–5.78], p < 0.05), and be monotherapies (AOR: 5.91, 95%CI [1.14–30.65], p < 0.05) than supplementary indications. Initial indications’ pivotal trials tended to be shorter (AOR per month: 0.96, 95%CI [0.93–0.99], p < 0.05), of lower phase design (AOR per clinical phase: 0.28, 95%CI [0.09–0.85], p < 0.05), and enroll more patients (AOR per 100 patients: 1.19, 95%CI [1.01–1.39], p < 0.05). Conclusions. Targeted cancer drugs are increasingly approved for multiple indications of varying clinical benefit. Drugs are first approved as monotherapies in rare diseases with a high unmet need. Whilst expedited regulatory review incentivizes this prioritization, indication-specific safety, efficacy, and pricing policies are necessary to reflect each indication’s differential clinical and economic value.

Bevacizumab for blinding eye disease &#x2013; is it time for the PBS to list for off-label use?

Anti-vascular endothelial growth factor eye injections have become the most accepted and effective treatment for some of the leading causes of blindness. Aflibercept (Eylea; Bayer) is the most expensive item on the Pharmaceutical Benefits Scheme, (PBS) with ranibizumab (Lucentis; Roche/Novartis) ranked eighth. In 2011 the pharmaceutical cost for these treatments was A$237 million - now the figure is A$665 million and climbing. Bevacizumab (Avastin; Roche) is part of the original molecular lineage for a group of biologic agents, which were originally designed for cancer therapy. It is now administered worldwide on an off-label basis and in very large numbers for retinal vascular disease. It has a proven efficacy and safety profile. Bevacizumab is thirty times cheaper than the Therapeutic Goods Administration (TGA)-approved alternatives and its use could reduce PBS costs by hundreds of millions of dollars. Should the TGA be the sole arbiter in the approval of drugs, or should alternative bodies have some say in the approval of off-label usage under such compelling circumstances? Legislation for this approach has been approved in France, the UK, and Italy. Only by eliminating the legal risk to authorising bodies and physicians, and the financial disincentive to the patient associated with off-label use, will drugs such as bevacizumab be more widely adopted.

Consumption, Wellness, and the Far Right

Consumption, Wellness, and the Far Right

Alloreactivity of Allogeneic Mesenchymal Stem/Stromal Cells and Other Cellular Therapies: A Concise Review.

Cellular therapies, deemed live medicine, have brought a wave of new generation biological therapies to treat previously untreatable diseases such as cancers and degenerative diseases like osteoarthritis. These cellular therapies have gained significant recognition in clinical research. The area has been further strengthened with the approval of Chimeric Antigen Receptor added on T cells (CAR-T) therapies by the regulatory authorities USA's Food and Drugs Administration (FDA), European Medical Agency (EMA), the Australian Therapeutic Goods Administration (TGA), and in many countries in 2017 to treat hematological cancers. Another milestone was achieved when allogeneic Mesenchymal Stem Cell- (MSC-) based therapy was approved by the EMA to treat Chrohn's disease in 2018. Allogeneic donor-derived MSC therapies in particular hold great promise and real hope because of their ‘off-the shelf' availability and accessibility for patients in need of urgent treatment. So far, thousands of clinical trials have explored the safety and efficacy of both autologous and allogeneic cell therapies, deeming them safe, however with varying degrees of efficacy. In the current pandemic, clinical trials have begun in many parts of the world to treat severe cases of COVID with MSCs. However, the risk of tissue rejection and the development of undesirable effects due to alloreactivity of allogeneic cells are currently not adequately addressed. Therefore, this warrants careful investigation and detailed reporting of such events by clinical researchers. This review aims at discussing the current landscape of approved allogeneic MSCs along with a few other cellular therapies. We explore any possible reactivity reported to inform the readers of any safety concern and on the efficacy of such therapies.

Case report of breast implant-associated anaplastic large cell lymphoma and a call for increased awareness

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare but serious complication of breast implants. The incidence of BIA-ALCL varies between 1:9121 and 1:13745, and a recent meta-analysis found that countries where specific monitoring measures have been implemented have higher rates of cases. While a significant complication, there is no current evidence to support surgical risk management strategies to prevent BIA-ALCL. Many countries have adopted a model of surveillance, and in Australia the Therapeutic Goods Administration has endorsed data collection through the Australian Breast Device Registry (ABDR). We present a case of a 67-year-old woman who presented to her GP with 2 months of left breast swelling, on a background of a left breast implant in 2004. MRI of the left breast demonstrated a large peri-implant fluid collection, and cytology confirmed BIA-ALCL, CD30-positive and ALK-negative. She underwent a capsulectomy and final histology demonstrated a Breast Implant-Associated Anaplastic Large Cell Lymphoma with focal penetration of neoplastic cells beyond the capsule and into pericapsular fat (stage T4). While development of registries and national guidelines has ensured the safeguarding of health outcomes for patients moving forward, there is still a concern for women with pre-existing breast implants who are unaware of the risk of BIA-ALCL. This case highlights the importance of raising awareness and providing support to primary health care providers to ensure their patients are given the necessary information to avoid this rare, but serious complication.

FDA Approval Summary: Nivolumab in Combination with Ipilimumab for the Treatment of Unresectable Malignant Pleural Mesothelioma.

On October 2, 2020, FDA approved nivolumab with ipilimumab as first-line treatment for adult patients with unresectable malignant pleural mesothelioma (MPM). The approval was based on results from Study CA209743 (CHECKMATE-743), an open-label trial of patients with MPM randomized to receive nivolumab and ipilimumab for up to 2 years (n = 303) or six cycles of chemotherapy with cisplatin or carboplatin plus pemetrexed (n = 302). Overall survival (OS) was improved for patients who received nivolumab and ipilimumab, with a median OS of 18.1 months [95% confidence interval (CI), 16.8-21.5] compared with 14.1 months (95% CI: 12.5-16.2; HR, 0.74; 95% CI, 0.61-0.89; P = 0.002), for patients who received chemotherapy. The magnitude of benefit was larger for patients with non-epithelioid versus epithelioid histology. Additional clinical pharmacology data support an alternative dosing regimen of nivolumab than evaluated in the trial, which will reduce the number of required treatment visits. This application was reviewed under FDA's Project Orbis, in collaboration with Australia's Therapeutic Goods Administration, Switzerland's Swissmedic, Health Canada, and Brazil's National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária). Nivolumab and ipilimumab is the first drug regimen approved by FDA for MPM since 2004.

Spinal Cord Stimulators: An Analysis of the Adverse Events Reported to the Australian Therapeutic Goods Administration.

BackgroundSpinal cord stimulators are used to treat intractable pain. Placebo-controlled trials of spinal cord stimulators typically involve short-term treatment and follow-up, so long-term safety and efficacy are unclear.AimThe aim of the study was to describe the adverse events relating to spinal cord stimulators reported to the Therapeutic Goods Administration of Australia between July 2012 and January 2019.MethodsAdverse events were coded by seriousness, severity, body system affected, type of event, action taken, and attribution of fault. Data on the number of stimulators implanted and removed were sourced from the Admitted Patient Care Minimum Data Set.ResultsFive hundred twenty adverse events were reported for spinal cord stimulators. Most events were rated as severe (79%) or life-threatening (13%). Device malfunction was the most common event (56.5%). The most common action taken in response to an adverse event was surgical intervention with or without antibiotics (80%). The ratio of removals to implants was 4 per every 10 implanted.ConclusionsSpinal cords stimulators have the potential for serious harm, and each year in Australia, many are removed. In view of the low certainty evidence of their long-term safety and effectiveness, our results raise questions about their role in providing long-term management of intractable pain.

Use of priority and provisional approval pathways by the Australian Therapeutic Goods Administration in approving new medicines: a cross-sectional study.

Objective Examine the use of priority and provisional approval pathways by the Australian Therapeutic Goods Administration (TGA) for evaluating new medicines. Methods This observational study assessed all new medicines approved by the TGA between 1 January 2018 and 18 October 2021. It examined how frequently priority and provisional approval pathways are being used, the conditions which the medicines are being approved to treat, how long medicines are spending in the approval pathways, the additional therapeutic value of the medicines being approved through these pathways and how the use of the pathways compares with similar regulatory pathways used by Health Canada. Results The TGA approved 138 new medicines in the time period under study, of which 33 were approved through either the priority or provisional approval pathways. Sixteen were approved to treat cancer. It took the TGA a mean of 130 (95% CI 118, 143) and 144 (95% 101, 188) working days for priority and provisional pathways, respectively. Therapeutic evaluations were available for 16 of these medicines and 11 offered little to no therapeutic gain over existing medicines. There was moderate agreement between the TGA and Health Canada in their use of these pathways (Kappa = 0.5458, 95% CI 0.3900, 0.7016). Conclusions The priority and provisional approval pathways are now being used by the TGA for about one-third of all new medicine approvals. Although the medicines approved in these ways are moving through the review process more quickly than those approved through the standard approval pathway, the majority of these medicines, for which an evaluation of therapeutic value is available, do not offer any substantial additional therapeutic value over existing medicines.

Critique of the Royal Australian and New Zealand College of Psychiatrists Psychedelic Therapy Clinical Memorandum, Dated May 2020

Objective: The Royal Australian and New Zealand College of Psychiatrists (RANZCP) has positioned itself against medically controlled patient access (at this current time) to 3,4-methylenedioxymethamphetamine (MDMA) and psilocybin-assisted therapies in its Therapeutic Use of Psychedelic Substances Clinical Memorandum, May 2020. The main reason given by the RANZCP for its stance is safety concerns. Methods: Every reference in the clinical memorandum (CM) was checked against the original publications used by RANZCP to justify its position. In addition, the search engines Google Scholar, PubMed, ScienceDirect, the Multidisciplinary Association for Psychedelic Therapies (MAPS) website, the Therapeutic Goods Administration (TGA) website, relevant Australian and New Zealand legislation were searched for pertinent and up-to-date- information. Results: There is no scientific or medical evidence from the last 70 years to suggest that either psilocybin or MDMA, when administered as an adjutant to therapy in a controlled clinical setting, are linked to either mental illness or negative health outcomes. On the contrary, MDMA and psilocybin have been shown to be safe, non-toxic, non-addictive, and efficacious when administered in a medically-controlled clinical environment. All associated risks are apparent in an uncontrolled setting. Conclusion: The RANZCP’s position is based on outdated, irrelevant, misinterpreted, and misinformed evidence. With the recent positive media coverage of the efficacy of these medicines when used as an adjunct to therapy, there is an intrinsic risk of self-medication or underground therapy. This means that any medical discussion must also purvey the ethical responsibilities and social duties associated with these substances.

A Pragmatic Randomized Comparative Trial of e-Cigarettes and Other Nicotine Products for Quitting or Long-Term Substitution in Smokers.

Tobacco harm reduction has potential to improve individual and population health. However, little research exists on low-intensity interventions, such as encouraging longer-term NRT or e-cigarette use. We aimed to determine whether: (1) encouraging use of nicotine products as long-term tobacco substitutes is more effective for smoking abstinence than standard treatment, and (2) offering e-cigarettes is more effective than NRT. An open-label, parallel-group randomized trial was conducted in Australia between 2014 and 2015, with 1563 adult daily smokers, randomized to: (A) standard cessation advice and NRT: advice to use NRT short-term, (B) quit or substitute advice and NRT: advice to use NRT as a longer-term substitute for smoking if required to maintain smoking cessation, or (C) Quit or substitute advice and NRT and/or e-cigarettes. Participants were offered an initial supply of products they could then purchase for up to 7 months. The primary outcome was self-reported continuous smoking abstinence at 7 months. Point prevalence, dual use, and cigarette reduction were secondary outcomes. At 7 months, 2.8% (N = 9) of group A (N = 324) were abstinent, compared with 1.8% (N = 11) in B (N = 620) and 1.3% (N = 8) in C (N = 619) (adjusted odds ratio [ORs]: B vs. A 0.66, 95% confidence interval [CI]: 0.27-1.63; C vs. A 0.46, 95% CI: 0.17-1.21; C vs. B 0.69, 95% CI 0.27-1.73). There were no suspected unexpected serious adverse reactions associated with trial products. A free trial of NRT and first generation e-cigarettes and advice on long-term substitution was no better for smoking abstinence than usual care. The trial was registered with the Australian Therapeutic Goods Administration under their Clinical Trials Notification scheme and the Australian and New Zealand Clinical Trials Registry (ACTRN12612001210864). This pragmatic trial allowed the comparison of existing and alternative policy options under semi-realistic conditions, such as product choice and financial cost. All trial arms had low rates of smoking cessation. The findings suggest that providing unflavored cigalike e-cigarettes without additional support may not increase quitting compared with advice to use standard NRT in a general population of Australians who smoke. More intensive support and education, and/or opportunity to try a range of e-cigarette products, may be required to motivate quit attempts using e-cigarettes.

FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non–Small Cell Lung Cancer, a Collaborative Project Orbis Review

Abstract On December 18, 2020, the FDA approved osimertinib as adjuvant therapy in patients with non–small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) mutations, as detected by an FDA-approved test. The approval was based on the ADAURA study, in which 682 patients with NSCLC were randomized to receive osimertinib (n = 339) or placebo (n = 343). Disease-free survival (DFS) in the overall population (stage IB–IIIA) was improved for patients who received osimertinib, with an HR of 0.20; 95% confidence interval (CI), 0.15–0.27; P &amp;lt; 0.0001. Median DFS was not reached for the osimertinib arm compared with 27.5 months (95% CI, 22.0–35.0) for patients receiving placebo. Overall survival data were not mature at the time of the approval. This application was reviewed under FDA's Project Orbis, in collaboration with Australia Therapeutic Goods Administration, Brazil ANVISA, Health Canada, Singapore Health Sciences Authority, Switzerland Swissmedic, and the United Kingdom Medicines and Healthcare products Regulatory Agency. This is the first targeted therapy adjuvant approval for NSCLC and has practice-changing implications.

Reactions on Twitter towards Australia's proposed import restriction on nicotine vaping products: a thematic analysis

ObjectiveIn June 2020, the Australian Government announced that personal importation of nicotine vaping products (NVP) would be prohibited, pending a 12‐month classification and regulation review by the Therapeutic Goods Administration. This brief report examines the themes of responses on Twitter to this announcement. MethodsSimple random sampling was used to retrieve tweets containing keywords from 19 to 26 June 2020. Tweets were manually coded and descriptive statistics calculated for themes and policy position. ResultsThe vast majority of the 1,168 tweets were anti‐policy. Themes included: criticism towards government (59.8%), activism against NVP restriction (38%), potential adverse consequences (30.8%) and support for NVP restriction (1.4%). Tweets that identified potential adverse consequences of NVP restriction cited: smoking relapse for individuals currently using NVPs (75.6%); the impact of policy enforcement (8.6%); illicit market (8.3%); panic buying (3.6%); difficulty obtaining prescriptions (2.8%); and impacts on NVP businesses (2.8%). ConclusionTweets predominately objected to the policy announcement. Approximately three‐quarters of tweets that cited potential adverse consequences of the policy mentioned smoking relapse as their primary concern. Implications for public healthUser‐generated content on Twitter was primarily used to lobby against the proposed policy, which was subsequently amended.

The Australian obesity epidemic and the regulation of complementary medicine weight loss products

ObjectiveInvestigate the response of the Therapeutic Goods Administration's (TGA) new advertising complaint system to resubmitted complaints about complementary medicine weight loss products previously upheld by the Complaint Resolution Panel. MethodsBetween July 2018 and July 2019, complaints about a convenience sample of 22 complementary medicines by eight sponsors, advertised on 140 different internet sites (cases), were resubmitted to the TGA. FatBlaster products featured. Follow‐up occurred in February 2021. ResultsA search of the TGA advertising complaints database found ‘no result’ for 84% of the 140 cases submitted. Despite the TGA delisting three products and sponsors delisting ten others, all products complained about were still being advertised. Some products had minor changes in imagery but not claims. The sponsor (Cat Media, Naturopathica) had listed three new FatBlaster weight loss products. ConclusionsThe TGA failed to protect consumers from ineffective weight loss medicines. Implications for public healthWeight loss medicines with misleading and deceptive claims are likely to divert users from evidence‐based weight loss activities. The TGA should ask for the evidence supporting promotional claims for these products and, if this is lacking, delist the entire class of products. For recalcitrant sponsors who repeatedly make egregious claims, civil and criminal penalties should be applied.