The departing TGA boss reflects on nicotine and psychedelics, and making the regulator more accessible and accountable.
Professor John Skerritt retires as head of the TGA on 18 April, leaving behind the regulatory framework he helped develop from scratch.
“I seem to have ended up on about 10 different advisory committees to government and universities,” Professor Skerritt told TMR’s Tea Room podcast.
“I’ve got a number of adjunct positions. I’m doing an awful lot of stuff on building the messenger RNA framework in Australia, both therapeutics and vaccines. We’ve all had the success of covid vaccines, but the question is what comes next?”
His last act is to oversee and convey the messages of the public consultation over nicotine vaping product to the federal government.
“Two years ago, when the prescription model came in, in the lead-up to it, there was a bit of sitting on the fence in public opinion, in the media and so forth,” Professor Skerritt said. “Was this too strong a move, etc.
“Now, 95% of them are saying we have a crisis with kids, even primary school kids, especially high school kids, and also young adults who are getting hooked on nicotine.
“So, I believe that while there will always be some people want to do something stupid and get hooked on nicotine or jump in front of a car, then it’s a free world. But I think the overwhelming view in the media and in the public discourse is that we don’t want Australia to become hooked on nicotine.
“We’ve spent 50 years getting off cigarettes, and I think there is an appetite for change. But really, that’s a decision of our political masters.”
In the past six months, some commonly prescribed medications have been in short supply, a situation that has sparked debate about whether Australia should be getting into the drug manufacturing business.
“Historically, in the last few years the [shortage] numbers are no higher, but we’ve had a few high-profile ones, whether it’s anti-diabetics, whether it’s the antibiotics, whether it’s steroids, the profile comes and goes,” says Professor Skerritt.
“There are two challenges with local manufacturing.
“First, I had a journalist asked me not long ago about Ozempic, for example, surely, they could just whip up another factory and make more of it.
“Now, I don’t know if you’ve seen the structure of that molecule. It’s very complex! Even the companies with all the patents and the expertise would take 1.5 to two years to build another factory to get manufacture up and running.
“There’s a certain naivety to think that you can just click your fingers and suddenly you can make something like Ozempic.
“On the other hand, if it’s one of the more common shortages, if it’s amoxicillin or dexamethasone, these things are being manufactured in India and China for a couple of dollars a packet. In Australia it will cost $20 a packet, just because of labour costs, real estate etc.
“We are a high-cost manufacturer. I think if somebody walks up with an amoxicillin proposal they could struggle with a business case showing how they can be cost competitive against India or China.”
One of the more controversial decisions made by the TGA in recent times has been the rapid down-scheduling of psychedelics MDMA and psilocybin for the treatment of depression after a long period of messaging that the down-scheduling wouldn’t happen.
“It wasn’t the result of being lobbied,” said Professor Skerritt.
“I had to counsel my staff to ignore it. The lobbyists were undermining their own case, to be frank. I was saying, look at the science, look at the medicine and look at the law.
“There were really two things that changed. There was another study published in the New England Journal of Medicine, which, although it wasn’t powered … it was fairly strong in its evidence that for certain people there could be advantages.
“The second big thing was legally it became clear to us that we could provide a second set of controls, and that was to restrict it to authorised prescribers. As soon as you do that, the use of it has to go through an ethics committee that looks at the trial design, or if it’s not a trial, looks at the pre-treatment protocol from both an ethical and medical and data powering and safety point of view.
“The other thing that we’ve been criticised for is people saying ‘but even the evidence now shows that psychedelics only work in a small proportion of patients’. Well, we know that SSRIs and SNRIs only work in a proportion of patients.
“The evidence base actually, for the psychedelics, is actually stronger than, say, cannabis.”
Professor Skerritt is proud of the work the TGA has done over his tenure.
“The biggest thing is that we’ve systematically been able to transform a regulatory system that’s now also a lot more accessible to patients and to doctors,” he said.
“We now get 87,500 phone and email inquiries from the public, from healthcare professionals and from industry, a year and we’re able to help a lot of people with their medications and so forth.
“Apart from still doing what regulators do and checking products, we have also expanded our role in public health dramatically, both in terms of communication around products and compliance and enforcement in enabling access to some of these experimental new therapies.
“The other thing we did was totally rework the medicines and medical devices regulatory framework. Now we have priority, provisional, other pathways that can get those medicines to patients much earlier.
“It is time for someone else to have a go and to bring in some new thinking.”
