I wonder what’s the difference between countries that drives that. It’s not like Brazil doesn’t have its own FDA, which is much more strict than the US one, from what I know. Maybe some kind of lobbying? Or are animal rights group that much stronger?

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skissane 8 hours ago | parent | next [-]

I was having a conversation about this with my father-a retired pharmaceutical industry executive-a few weeks back, about why certain generic prescription medication formulations were unavailable in Australia yet sold in New Zealand. He explained to me that the Australian pharmaceutical regulator (the TGA) and its New Zealand equivalent (Medsafe) had very different regulatory philosophies. Medsafe, if a major international regulator (such as the US FDA or the EU’s EMA) had already approved something, they’ll just approve it too (“if it is good enough for them it is good enough for us”); the TGA’s attitude was very different, just because the FDA or EMA had approved it didn’t mean they automatically would, they wanted to analyse the safety data for themselves and make up their own mind. For blockbuster patented drugs, the extra regulatory cost of Australia was worth it, but for the long tail of miscellaneous generic formulations, the extra cost of dealing with the TGA could make some of them financially nonviable.

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tehjoker 7 hours ago | parent [-]

Medsafe's strategy only works so long as there is at least one stringent regulator though.

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AuryGlenz 7 hours ago | parent [-]

I would think for a country like Australia a more moderate approach would be to approve things that were approved by other countries and have been in use for some amount of time - say, 5 years or so - apart from the things they directly approve.

	▲	skissane 7 hours ago \| parent [-]
		The actual drug my father and I were discussing was clonidine. In the UK and New Zealand, they sell 25 microgram clonidine tablets; in Australia, the smallest dose on sale is 100 micrograms. Clonidine is a very old drug – it was released back in the 1960s. The risks involved are very well understood (arguably the biggest risk is fatal overdoses, but patient/parent education is the accepted mitigation strategy.) The issue is, in Australia, it is only approved for treating high blood pressure in adults. Paediatricians and child psychiatrists commonly prescribe it for ADHD, and for anxiety, aggression and insomnia (particularly but not exclusively in the context of ASD); in adults, it is prescribed to treat menopausal hot flushes and migraines – but all those indications are off-label. And this is the problem – given the doses involved, 25 microgram tablets only really make sense for those off-label indications, there isn't much demand for them for treating adult hypertension. So to get the TGA to approve 25 microgram clonidine tablets, you need to prove to them that clonidine is safe and effective for one of those currently off-label indications. And that will cost a lot of money, and given it is a generic medication long out of patent protection, it isn't worthwhile. Whereas Medsafe quite possibly just decided "the UK approved it for X so we will too". As a parent, both of whose children are prescribed clonidine, this annoys me – cutting tablets in half is no fun, and cutting them into quarters is even worse. Or I can get them compounded into liquid by a compounding pharmacist, which makes it easier to measure out smaller doses (I always get 25 microgram/ml), but that adds expense and time (the nearest compounding pharmacy is 15 minutes drive one way). I just wish I could get 25 microgram tablets, but they can't legally be sold in Australia–possibly I could ask our child psychiatrist to apply for special permission to import them from New Zealand, but the amount of bureaucracy involved probably isn't worth it, there's no guarantee the request would be approved, and it would be expensive (it wouldn't be covered by our national prescription drug insurance).

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MattGaiser 8 hours ago | parent | prev [-]

I imagine it is about this:

> But Brazil lacks the human skin, pig skin, and artificial alternatives that are widely available in the US.

This is not an improvement on existing methods (it may end up being, but that is not the motivation) but rather a case of it being all they have to work with.

Tilapia skin is probably better than no skin at all.

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hu3 8 hours ago | parent [-]

> This is not an improvement on existing methods... a case of it being all they have to work with.

But the article says Tilapia skin is better in multiple aspects:

> "We got a great surprise when we saw that the amount of collagen proteins, types 1 and 3, which are very important for scarring, exist in large quantities in tilapia skin, even more than in human skin and other skins," Maciel said. "Another factor we discovered is that the amount of tension, of resistance in tilapia skin is much greater than in human skin. Also the amount of moisture."

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dmurray 7 hours ago | parent [-]

It says it's different to human skin in multiple aspects.

Do I need more collagen or more moisture in my skin? I would expect evolution made some pretty good choices around default human skin for typical human activities, and if more moisture was obviously good, I would already have it.

Maybe tilapia skin is better for people who spend 24 hours a day swimming in lakes.

	▲	hu3 7 hours ago \| parent [-]
		> It says it's different to human skin in multiple aspects. No it says "even more than in human skin and other skins". Not different. > Do I need more collagen or more moisture in my skin? For this context? Yes? Clearly the article answers that already. I even included in my first reply but you'll have a third chance to read it: > ...which are very important for scarring... And your attempt to move the goal post fails miserably as well. Or do you think humans evolved to perfection by thinking this: > I would expect evolution made some pretty good choices around default human skin for typical human activities, and if more moisture was obviously good, I would already have it. I don't think you are debating in good faith. Good luck.