In early December 2025, the U.S. FDA announced immediate and sweeping reforms to its vaccine approval and monitoring processes. These changes include stricter clinical trials, restrictions on high-risk groups such as pregnant women, and a comprehensive overhaul of vaccine safety monitoring.
I asked the Australian TGA whether they were following these developments and if there was a need for Australia to adopt similar measures. Their response was a “no,” wrapped in many pointless words.
Health Secretary Kennedy is making great progress in dragging the medical establishment back to the center. At present, I believe pharmaceutical companies and their profits exert too much influence on our health administration, to the detriment of common sense, honesty, and duty of care.
I will continue to hold the TGA to account.
– Senate Estimates | December 2025
Transcript
Senator ROBERTS: For now. The FDA announced immediate and sweeping reforms to their vaccine approval and monitoring processes, including stricter clinical trials; restrictions on high-risk groups, such as pregnant women; and an overhaul of the vaccine safety monitoring system. This is going on under a new administration. The reforms closely mirror measures which operated in Australia until COVID, when our safety assessments and monitoring were watered down with fast-track approval and emergency-use authorisation for a multitude of drugs. Will you accept that weak approval processes, high-adverse events and blanket denials that anything is wrong have undermined confidence in the entire health system in this country?
Prof. Lawler: There are a couple of things there, if I might comment. We didn’t use emergency-use authorisation. We adopted what is called a provisional pathway—
Senator ROBERTS: It’s equivalent.
Prof. Lawler: It’s not equivalent; it’s quite different. The reason that we undertook it was that, like the rest of the world, we recognised that there were risks that the community was facing, and we worked very closely with other regulators to understand what was emerging. Tonight, you previously mentioned relying on the FDA. It’s really important that, when we talk about reliance, it’s a specific term. It’s not like, if the FDA has approved it, then we automatically register it—
Senator ROBERTS: I’m just using Professor Skerritt’s words.
Prof. Lawler: I wasn’t here when Professor Skerritt gave you those words; I’m just trying to explain where we’re at.
Senator ROBERTS: He said he didn’t do any testing here—
CHAIR: Senator Roberts, can we let Professor Lawler finish his answer, please.
Prof. Lawler: It’s not like, if the FDA hasn’t approved it, we say, ‘You shall not pass.’ What happens is that we look to the information that other regulators have when making our own decisions. I think the important thing as well to note is that we do very much rely on our approvals. We do have, as other regulators have, both pre-market and post-market evaluation and monitoring. But the point that you made about trust is a very important one. We had a presentation at our International Coalition of Medicines Regulatory Authorities earlier this year about trust. There was a very strong driver of trust in institutions, in regulations and in health professionals. The very strong downward driver of it is misinformation and disinformation. Part of the challenge that we have is that, as we hear very frequently, there are a lot of studies, for instance, of very low quality that are being taken up and used as evidence or proof of causal links that just do not exist. Part of the challenge we have is that we do strive to rebuild trust. On two occasions in the last two months, the chief medical officer and I have endeavoured to do that through public statements, and it is a constant battle.
Senator ROBERTS: It’s something we’ve found agreement on. I understand there was a paper in the Lancet a few years ago that said that 50 per cent of medical papers are not valid. Now, we’ve got increasing knowledge coming out and evidence showing that big pharma has heavily influenced the scientific papers and has corruptly done so. This is my last question. Will you monitor the changes in the United States in case the new team under Kennedy is actually right about what has gone before them and right about the changes being necessary?
Prof. Lawler: We monitor all of the developments by our international collaborative partners in regulation.
I spoke with Dr. Marcelle Noja, who expressed sympathy for those whose health has been compromised by mesh complications.
When asked about the Australian Pelvic Floor Procedure Registry’s failures in following up with patients, she stated that this question would be taken on notice.
I also inquired about the steps the government is taking to assist with the cost of remedial surgeries; this question was likewise taken on notice.
Regarding the differences in approach taken by the UK and New Zealand—where mesh has been banned or severely restricted—I was informed that, because the mesh is used for other treatments, Australia has decided against a total ban on the product.
Due to time constraints, I will submit the remaining unasked questions on notice.
— Senate Estimates | December 2025
Transcript
Senator ROBERTS: Let’s move on to pelvic mesh. Following a Senate inquiry, a formal government apology, overwhelming evidence of harm and international bans in multiple countries, transvaginal mesh continues to be implanted in Australian women daily. Can you explain why these devices have not yet been banned and what specific evidence would be required for the health department to recommend an immediate hold to their use?
Dr Noja: Thank you for this question and thank you advocating for many of the patients who have had urogynaecological mesh and had negative outcomes as a result of it. The TGA was similarly concerned with the impacts of urogynaecological mesh. That is why we have taken a number of actions in relation to this. When we look at postmarket activities in relation to mesh, and in fact all products, we undertake a risk analysis, we look at the evidence, and we go to the companies and ask them for information in relation to those products. When it came to these products, we did look at the products and we found that, for many, the evidence was not there to support their ongoing inclusion. Many of those products were actually removed from the Australian Register for Therapeutic Goods. However, for some of the products, we did find that, for some health conditions, there was still benefit for patients. So, for those products, we have continued to include them in the register. However, in support of patients, we have done other activities. We have undertaken a number of reforms. Some of those include increasing information for patients. That means more information about the product, more information about what may occur and working closely with the health professionals to make sure that information does get to consumers. We’ve also recently implemented mandatory reporting regulations for mesh. What we found was that the TGA did not have significant signals to be able to act on doing something. Under this new regulation, it will be mandatory for healthcare facilities to report all adverse events to us. We will then be able to pick up signals sooner and act faster. We continue to monitor this, and this includes undergoing ongoing signal-detection activities. These are critical devices for some Australians, so we really have to be balanced in what we remove from the register versus what we allow to continue, as well as how patients can access it.
Prof. Lawler: I’ll add briefly, as Dr Noja has said, that the role of the regulator is to understand the balance between the risk to patients and the benefits to patients. As we’ve heard, there are certain instances with certain products and certain conditions where there continues to be strong benefit. One of the roles that we take as a regulator is to regularly update product information so that the information that’s necessary for patients to make informed decisions is available to them for conversation with their registered health practitioner.
Senator ROBERTS: Dr Noja, perhaps you can correct me on this, but this is my understanding—I take note of what you said—on the back of the 2018 inquiry, a pelvic mesh registry, the Australian Pelvic Floor Registry, was established. Unfortunately, this registry fails to track long-term health outcomes of mesh affected women, because it only tracks certain women from certain hospitals and only for a period of 24 months. That may have changed. You can correct me if I’m wrong. Will the government amend the failings of the Australian Pelvic Floor Procedure Registry and instead establish a comprehensive, long-term health monitoring program?
Dr Noja: Responsibility for the pelvic floor mesh registry doesn’t sit with the TGA; it sits with my colleagues in another part of the department. I’m not sure if our colleagues from HERD are here. I don’t believe they are. We can take that on notice and talk to our colleagues to provide you with an answer.
Senator ROBERTS: Thank you. The mesh clinics established after the 2018 inquiry are fundamentally failing women by providing only partial medical intervention. Apparently these clinics will remove mesh devices but categorically refuse to repair the resulting extensive damage, leaving women in a state of severe medical compromise. Can you explain why these clinics are permitted to create additional harm?
Prof. Lawler: We’re not familiar with the practices of those clinics. The regulation of clinics and health practitioners is not a responsibility of the TGA, and, as I mentioned previously, these are largely conversations between patients and their treating health practitioners. We are not responsible for the management of the operation of those clinics.
Senator ROBERTS: Can you give any advice to women who are still in a lot of pain—not medical advice, but where to go?
Dr Noja: The TGA has established a range of information on our website. We have what’s called the mesh hub, and I’m happy to provide that link to anyone in the committee, if that’s helpful. The mesh hub includes a range of information for people who have suffered from mesh injury. It includes information about accessing various aspects of our Medicare system as well as treatment options and information about other services that are available to them.
Senator ROBERTS: The mesh hub?
Dr Noja: That’s correct.
CHAIR: Senator Roberts, I’m just flagging that I will need to shift the call shortly.
Senator ROBERTS: I’ll keep sprinting.
CHAIR: You’re in the sprint, yes.
Senator ROBERTS: Every day Australian women are facing an impossible choice due to pelvic mesh complications—and I’m sure you’re aware of that—draining their retirement savings and suffering ongoing medical trauma. Many women are forced to access their superannuation on compassionate grounds to fund critical mesh removal or repair surgeries, while others completely forgo necessary care due to prohibitive costs. What steps will the government take to establish a comprehensive support system for women that covers the full cost of surgeries and ongoing care that they need from being harmed by a government-approved medical device? Perhaps the minister might want to comment, as well as you, Dr Noja.
Dr Noja: I will allow the minister to comment, but I will just note that our website does include information for patients with respect to what services they can seek support with. There are a number of MBS and PBS items available to them, which they can seek access to, and there are a number of available resources there for them.
Senator Green: For completeness, I’ll take your question on notice so I can provide you with some information about what supports are available. I don’t disagree with you that these women have gone through an awful ordeal. I’m confident that we’ll be able to give you some fulsome information about what’s available, but you should continue to raise these issues.
Senator ROBERTS: Last question in this sprint—the UK, Scotland and New Zealand have banned or severely restricted transvaginal mesh use, due to unacceptable harm rates, but Australian women continue to receive these implants daily. That doesn’t seem to make sense to me. What makes Australian women different from British or New Zealand women and justifies continuing a practice that other countries apparently have deemed too dangerous?
Dr Noja: I will note that the TGA doesn’t tend to ban devices. Our approach is around inclusion versus exclusion of products so that there remain a number of pathways available to clinicians should they deem it appropriate for a member of the public to have access to a product. The reason we don’t ban products is that it is important that patients get the best appropriate care for their individual circumstance. I really respect your comments around what we are doing to protect women, and, as I mentioned, we have actually undertaken a number of actions specifically related to these products. As part of our post-market review and our action, we did upclassify some products and remove others, but it is important that these products remain available. They are used for other surgical procedures, apart from urogynaecological conditions, so it is important we make sure that access is available. We just have to have rigour around where access occurs to ensure that the products are fit for purpose in how they’re being used. Part of that, really, is the patient information and making sure that patients are appropriately provided with all the information they need to support them in making sure that it is the right decision for them.
Senator ROBERTS: I hear what you say, and I acknowledge it, but why is the mesh banned in other countries and not banned here?
Dr Noja: I don’t believe it is banned in other countries. Australia has taken the step to upclassify these products. Other countries have not gone as far as Australia has, in terms of its regulatory approach. Some countries are continuing to look at these products and make decisions about what they do, but they will be making those decisions based on the evidence they have in front of them and the signals and risks that they’ve seen in the patients that are presenting in their jurisdiction.
Prof. Lawler: In your question you did say that in other countries these products have been banned or significantly restricted. As Dr Noja has indicated in her answer, we have also undertaken some actions that have restricted those devices, through the upscheduling and through the removal of some from the register, and also through the imposition of conditions of inclusion. So we have taken regulatory actions as well.
Senator ROBERTS: So you’re going to send me more information and the minister is going to give me an answer on notice, and I’m going to stay on the treadmill.
This exchange during Senate Estimates with the Therapeutic Goods Administration (TGA) sums up just how bad Estimates has become under the Albanese Labor Government.
The TGA is well aware that Senators only have a few minutes to ask questions, and they understand that the more they can stall, the less likely it is they’ll have to say anything that could cause problems for their Minister—regardless of the truth. Because of this, the Minister will not require the “witness” to answer the question, nor will the Committee Chair—both of whom are Labor Senators.
My first question was a genuine attempt to clarify misinformation circulating online about aluminium intake. The answer was a simple “yes.” Keep that in mind when you watch the video. Instead of confirming the obvious and allowing us to move on to another question about aluminium in vaccines, the opportunity was taken to stall for time by debating whether the question should even be asked at all. Dr. Lawler, Deputy Secretary of the Health Products Regulation Group within the Department of Health, oversees the agencies and committees the Government uses to spread responsibility, avoiding accountability. He was exactly the right person to direct these questions to.
The data I presented was straightforward: the level of aluminium in vaccines is unsafe for infants by an order of magnitude. Yet the TGA spent a great deal of time on their pre-prepared responses insisting that vaccines are safe. They refuse to accept any data showing that this level of exposure is causing health issues in infants. I then asked whether our vaccines had been subject to gold standard testing—a term used on many occasions by “witnesses” attending Estimates to defend COVID vaccines – yet suddenly, the gold standard is no longer relevant to … vaccines! Suddenly, testing a product against a double-blind placebo (saline) is now considered “unsafe,” despite this being the standard for a century?
In reality, what Big Pharma has been doing for years—and what the TGA has allowed them to do in Australia—is to compare new vaccines (or medications for that matter) against existing ones, rather than saline. If the harm detected is the same as that already being caused by the “placebo” medication, it’s deemed safe. This is not how things should be.
I will continue this line of questioning until we get a proper inquiry into the level of heavy metal contamination in infant vaccines.
— Senate Estimates | October 2025
Transcript
Senator ROBERTS: Thank you for being here again, especially Professor Lawler. Before I start, can we deal with a statement I hear on the internet all the time—that you get more aluminium in your food than you do in vaccines. Aluminium in food is ingested at 0.3 per cent. In vaccines, it’s ingested at 100 per cent. Individual results may vary. Is this a fair statement?
Prof. Lawler: I’m not sure where you’re seeing that. I don’t have the information you’re referencing in front of me.
Senator ROBERTS: I’m asking you whether it’s accurate.
Prof. Lawler: I’m not sure that is necessarily a question for the TGA to respond to. We can provide you with information on the process that we undertake in terms of the evaluation and authorisation of therapeutic goods, including vaccines. Is this a claim that the TGA has made?
Senator ROBERTS: No. That’s my understanding. What is the TGA’s recommended maximum daily intake of aluminium for a child aged six months, please?
Prof. Lawler: By mouth as a recommended daily intake?
Senator ROBERTS: Yes.
Prof. Lawler: I don’t believe that the TGA sets a recommended daily ingestion of aluminium, Senator.
Senator ROBERTS: What is the daily maximum for a child of six months that can ingest aluminium in food?
Prof. Lawler: I would suggest that those are probably questions best posed to Food Standards Australia New Zealand, Senator.
Senator ROBERTS: The US Food and Drug Administration recommends exposure of five micrograms per kilogram in infants. At six months, the average weight of an infant is seven kilograms, making the maximum daily exposure 35 micrograms. The Infanrix hexa vaccine contains 825 micrograms of aluminium per dose, which is 24 times its safe daily limit. Do you accept injecting children at 23 times the safe level? Do you accept that this unsafe aluminium exposure is a contributing factor to aluminium derived autism?
Prof. Lawler: I will throw to Dr Dascombe in a moment. I will answer a couple of the things there in reverse order, if I may. The first is that, in answer to your second question, no. I don’t believe that there is a recognised regulator—I’m happy to be corrected—that does.
Senator ROBERTS: Rather than relying on someone else, do you have any data or research?
Prof. Lawler: I’m just trying to answer your question. I don’t believe that there is another regulator. I’m just using that as back-up. We have seen no credible safety signal that aluminium load either in single or scheduled immunisation delivery is a contributor to autism. The second thing I would say is that I am not sure this is the forum, nor do we have the time, to clarify the distinction between injected and ingested aluminium. They are quite different biomechanical processes. I don’t think the two are comparable. I will ask Dr Dascombe to add to that answer.
Dr Dascombe: I echo the comments of Professor Lawler. Neither the TGA nor any international regulator has detected or confirmed any safety signals relating to any vaccine and autism. This is also supported by the weight of scientific evidence.
Senator ROBERTS: What is the TGA guidance for the injection of multiple vaccines into a six-month-old at the same time causing amplified aluminium? Each of those doses has aluminium adjuvant, a preservative, so each of them is 24 times the daily safe limit.
Prof. Lawler: My apologies for breaking in, Senator. There are a couple of points on that. It is not the practice or the role of the TGA to make recommendations on immunisation schedules. That sits within the province of ATAGI, the Australian Technical Advisory Group on Immunisation. I would also highlight that we have frequently responded to questions around the aluminium load in the vaccination schedule and their consequences. Most recently, but perhaps more recently, is a Senate question on notice 24-003075. We have discussed it in this place a number of times.
Senator ROBERTS: You see the problem. Just one vaccine can be 24 times over the safe daily limit. You are recommending injecting multiple of them at the same time. These infants could be getting over 100 times the safe limit and you just keep on injecting them right in there and then claim aluminium poisoning isn’t the reason they come down with autism in some cases the very next day. How can you justify this?
Prof. Lawler: I will answer those questions in reverse order, if I may. I will answer the second. There is no indication that the vaccination schedule is linked to autism. Indeed, it has been highlighted not just today but previously. There’s no credible evidence that there is a linkage between vaccination and autism. As I just indicated in my previous answer, it is not the role of the TGA to recommend vaccinations. We assess them for safety, quality and efficacy. It’s the role of ATAGI to recommend the vaccination schedules.
Senator ROBERTS: Why don’t you tell the pharma companies to reduce the aluminium preservatives down to safe levels so you can get parents to trust your vaccine again and the parents can trust your advice again?
Prof. Lawler: There are a couple of elements in your question. We evaluate the submissions from sponsors and evaluate the process of manufacture and quality control to ensure that the balance of risk versus benefit is appropriate. That is a determination that we make not only in the authorisation but also in the post-market monitoring through our pharmacovigilance of any therapeutic good with the inclusion of vaccines. In terms of trust, we recognise that there is an active campaign to undermine the trust of regulators, the TGA particularly. We undertake to restore or bolster the trust of the public, which I have to say was during the pandemic and is still, despite some narratives, at a high level. We seek to do that through education and guidance. We do that through being very clear and transparent about what we do and by addressing dis- and misinformation when and if it occurs.
Senator ROBERTS: How many vaccines in the Australian schedule have been subject to a gold standard trial, meaning specifically a randomised double blind placebo control study where the placebo is saline and not another vaccine?
Prof. Lawler: I recognise that you weren’t here before lunch. We had a conversation with Senator Antic regarding the use of the term ‘gold standard’. We recognise that the use of a placebo control randomised double control trial—there are a number of different terminologies used—is of a very high standard and presents robust and dependable evidence. The challenge, of course, is whether something constitutes a gold standard in the way that you have used it. It actually very much depends on context. We use controlled or blinded trials or placebo trials when we are interested in determining the difference between a control arm and an intervention arm. This is really effective when we’re looking at incremental improvements in therapies or when we’re looking at the introduction of new therapies. The challenge we have, of course, is that when there is an established therapy that has been shown over decades using both documented and real-world evidence to be both safe and effective, it is ethically questionable—and, in some instances, ethically indefensible—to use a placebo in that non-intervention arm. I will give you two examples, if I may. We have vaccine preventable diseases, and we have a very clear demonstration of reduction in not only mortality but morbidity in those diseases. Let’s choose polio and small pox, diseases that have had a specific impact for many decades and have led to untold suffering. One of them has been eradicated by the use of vaccines and one of them has been virtually eradicated. If we were to introduce placebo controlled trials for those drugs, that would be horrendously unethical. We would be essentially and knowingly infecting children with a disease that could kill, paralyse or maim when we know that there is a way of preventing that. That’s not ethically defensible.
Senator ROBERTS: What you are saying is that there has been no double blind placebo control study where the placebo was saline and not another vaccine?
Prof. Lawler: No. What I am saying is that would not be an appropriate approach to be taking today with the vaccines we use.
Senator ROBERTS: Has it been taken in the past?
Prof. Lawler: I also would highlight that the introduction of vaccines occurred some time ago. And also—
Senator ROBERTS: So it has not been done?
Prof. Lawler: I will let you finish.
Senator ROBERTS: So it has not been done, then, the tests?
Prof. Lawler: Whether these—
Senator ROBERTS: A double blind trial?
Prof. Lawler: Well, we’ve actually already taken on notice to provide concrete evidence on which of those vaccines has been subjected previously to blinded control trials.
Senator ROBERTS: How many COVID vaccines have been destroyed because they aged out? What was the purchase cost for those products?
Prof. Lawler: Dr Anna Peatt from the national immunisation division will respond to that.
CHAIR: This is your last question, Senator Roberts.
Dr Peatt: Senator, could you please repeat the question? I didn’t quite hear it.
Senator ROBERTS: Certainly. How many COVID vaccines have been destroyed because they aged out? What was the purchase cost for those products?
Dr Peatt: Senator, I would have to take that question on notice. I don’t have that available with me today.
Senator ROBERTS: Was close to 35 per cent of the multibillion-dollar COVID vaccine supply binned or trashed?
Dr Peatt: I would have to take that question on notice.
Senator ROBERTS: I am asking for you specifically to tell us whether or not it was 35 per cent.
Dr Peatt: I don’t have that figure in front of me.
Senator ROBERTS: I am asking for you to just say what the figures are. Can you confirm that is 35 per cent of what we bought?
https://img.youtube.com/vi/uj4SbhAiGMU/maxresdefault.jpg7201280Senator Malcolm Robertshttps://www.malcolmrobertsqld.com.au/wp-content/uploads/2020/04/One-Nation-Logo1-300x150.pngSenator Malcolm Roberts2025-10-22 18:08:302025-10-22 18:08:37A Case Study in Avoidance
One Nation will restore direct oversight, supervision, accountability, and control to Parliament, removing influence from pharmaceutical companies over drug and product approvals.
Recently the head of the Therapeutic Goods Administration (TGA) Professor Skerrit left his role at the TGA and commenced work with Medicines Australia, which is the lobby group for the pharmaceutical industry. In effect, the professor is now working for the companies he recently regulated.
This is entirely unacceptable. The health of everyday Australians and trust in the medical establishment is too important to leave in the hands of a broken system rife with cronyism and self-interest.
We will return the power to authorise drugs and medical devices back to the Minister for Health, who will be responsible for delegating these decisions to his own departmental staff.
This system will ensure that the Minister’s decisions will be subject to rigorous parliamentary scrutiny, prevent conflicts of interest and most importantly remove the direct relationship between the TGA and pharmaceutical companies they are supposed to regulate.
Security of employment in the public service should prevent the revolving door we currently have between the TGA and pharmaceutical companies and ensure the best possible outcome for everyday Australians.
https://i0.wp.com/www.malcolmrobertsqld.com.au/wp-content/uploads/2025/04/ethan-hooson-6U-dmJ7WoDk-unsplash.jpg?fit=1026%2C684&ssl=16841026Senator Malcolm Robertshttps://www.malcolmrobertsqld.com.au/wp-content/uploads/2020/04/One-Nation-Logo1-300x150.pngSenator Malcolm Roberts2025-04-22 18:27:222025-04-22 18:27:54Restoring Parliamentary Oversight and Accountability in Drug and Product Approval
Senator Roberts rejects an extension to the QLD Chief Health Officer’s extraordinary powers in his submission to QLD Parliament’s Health and Environment Committee.
The sweeping powers, that allowed the state’s Chief Health Officer (CHO) to regulate people’s behaviour during the COVID pandemic, were initially introduced without consultation or debate.
Senator Roberts said, “A strong health response is the critical initial response to a pandemic, yet it is the Premier’s job to show political leadership and be accountable for the broader impact for Queensland.
“While lockdowns can be a solid initial strategy, the continued knee-jerk use of them after 11 months is an admission of failure. The ongoing damage to the economy will undermine people’s future physical and mental health.
“The Premier has been hiding in the shadows of the CHO’s health dictates since March and the economy, small businesses and Queenslanders have been left to languish.”
The role of the Chief Health Officer, an unelected bureaucrat, is to provide health advice for the Premier’s consideration as our elected representative.
“Over the past months the Premier has consistently abandoned the running of the state and instead allowed the CHO, who has responsibility for our physical health not our economic health, to be our defacto Premier.
“Only an elected government can be held accountable over the curbing of our rights and liberties, which is now beyond what is necessary,” stated Senator Roberts.
The ongoing extension of the delegated powers to the CHO puts her in a difficult position and may breach fundamental legislative principles, since the CHO’s unilateral decisions are way beyond her remit and her professional expertise.
Senator Roberts added, “Queenslanders voted for the Premier to be the ultimate decision maker, yet she shows reckless indifference to the importance of managing our state’s physical, mental and economic health.
“Anastacia Palaszczuk has surrendered her responsibility as a Premier. “The Premier needs to get back to work and the CHO’s extraordinary powers should be stopped and the position be returned to its intended advisory capacity only.”
