Medsafe

I've been talking to the regulators.

That's called MedSafe here.

I don't know.

It's the equivalent of like FDA.

And then we monitored them over time for 12 weeks.

Early on, what we learned was that there was a lot of resistance to referring people to our clinical trial because they worried that the nutrients would be harmful to the baby.

And in all fairness, even though we had data on all those single nutrients and we had put that to the equivalent of FDA, the MedSafe, and they had approved it remarkably, you know, the Interestingly, the amount of resistance we got to doing this trial was small, which was relative compared to all my other clinical trials.

I thought we're never going to get this through ethics.

many things on the health front, for example, 12-month prescriptions up from three, allow Kiwis, particularly those managing chronic health conditions, to save time and money.

Medsafe introduced the rule of two, something that all three coalition parties campaigned on.

Now, if a medicine has been consented in two other developed countries in the last four years, it will be available and consented here within 30 days.

We have also aligned over-the-counter labelling requirements with Australia, so more over-the-counter medicines can be sold here at better prices with more choice.

But yeah, it's all achievable though.

So who is it that oversees what you do, Joe, and people like yourself? Is that Medsafe? Is there a government department that also oversees all that?

Yeah, there's a slightly separate – it's kind of one degree separated from the government, one degree separated from Medsafe.

So we have a medicinal cannabis agency, and they're the ones that oversee us.

We do annual audits and things like that.

While the US prepares to get a more conventional access pathway to psychedelics off the ground via FDA approval, drug regulators down under are taking less traditional actions.

Earlier this month, New Zealand's drug regulator Medsafe greenlit a limited MDMA prescribing scheme that allows two Kiwi psychiatrists to offer the drug to patients with PTSD.

That comes a year after the country took the same move with psilocybin for treatment-resistant depression.

I spoke with one of the approved psychiatrists, Dr. Gary Nguyen, who told me that the process took 13 months.

He expects to dose up to 15 patients a year, for example.

While it's starting with just two psychiatrists, more clinicians are expected to apply very soon, but a key barrier will continue to be cost, with no public funds available for this treatment in New Zealand.

The move by Medsafe to allow certain clinicians to prescribe both psilocybin and MDMA mirrors that of its larger neighbour, Australia, which did so three years ago.

While uptake has been slow there too, it has made some progress on the reimbursement front, with one private payer, Medibank, and one public payer, the Department of Veterans Affairs, reimbursing psychedelic-assisted therapy there.

In news from New Zealand, a pharmaceutical company wants to make the cold and flu drug pseudoephedrine easier to buy.

Rickett Benkiser has put in an application with New Zealand's drug regulator Medsafe to lower the restrictions on pseudoephedrine.

Rowan Quinn reports.

Pseudoephedrine can only be bought after consultation with a pharmacist and stays behind the counter.

That was loosened to the current rules two years ago.

Ricketts says criminals now tend to import ingredients rather than source them locally.

The public can make submissions before Medsafe decides next month.

In world news, searches are underway for 130 passengers and crew missing from a stricken passenger ferry in the Java Sea of Indonesia.

The Sunday Session.

So on Friday, we saw Medsafe give two New Zealand psychiatrists approval to prescribe and administer MDMA for the treatment of post-traumatic stress disorder.

This form of therapy has been available in Australia for a few years now.

They led the way approving the treatment back in 2023.

A pharmaceutical company wants to make the cold and flu drug pseudoephedrine easier to buy.

Rickert Brenkheiser has put in an application with drug regulator Medsafe to lower the restrictions on it.

Rowan Quinn reports.

Pseudoephedrine can only be bought after consultation with a pharmacist.

That was loosened to the current rules two years ago.

Reckitt says criminals now tend to import ingredients rather than source them locally.

The public can make submissions before Medsafe decides next month.

Auckland's long-anticipated city rail link is opening tomorrow, bringing three new underground stations and new connections across the train network.

And by the time we finally do have that access, it's at a third of the price that was originally asked for because everyone kind of gives up or we just simply don't get the access at all.

Yeah, it's, well, David Seymour, the Pharmac Minister in New Zealand, has directed Pharmac and Medsafe to identify ways of incorporating AI into to make outcomes faster.

Now, that goes to the letter of expectations, and you've argued for that, that our ministers should set expectations for these committees, which I absolutely agree with.

And I think it's a great idea.

Uh, my colleague, friend, um, and co-researcher, Professor Julia Rucklidge from the University of Canterbury, a psychologist who runs high-dose micronutrient trials around mental health and has profound, uh, positive effects, uh, better than most psychiatric medicines without the side effects.

Uh, uh, you know, interestingly, Medsafe, our medical, uh, regulator, just this week on Tuesday decided because her trials had shown, uh, medical benefit, they should no longer be c- considered supplements.

They should be c- considered medicines.

Because they're not approved as medicines, um, they should be withdrawn from the market.