[skissane]

> and that crackdown is - depending on who you ask - partially/fully responsible for the stimulant shortages the past few years.

Australia has been experiencing psychostimulant shortages in recent years, but they haven’t been due to the DEA (or Australian equivalent thereof-most of the DEA’s functions are state government responsibilities in Australia), they’ve been explained as due to manufacturing issues and growing demand - https://www1.racgp.org.au/newsgp/clinical/further-adhd-medic... - while I totally believe the US is facing additional issues due to its own regulatory regime, if Australia is having supply issues independent of that factor, why wouldn’t the US too?

Since controlled substances prescribing is a state issue in Australia, each state has its own policies - but I know my state (NSW) has been loosening regulation not tightening it - https://www1.racgp.org.au/newsgp/clinical/first-phase-of-gp-...

[Maxious]

The shortages are due to the DEA, you can read the documents on the TGA FOI website what "manufacturing issues" really means https://www.reddit.com/r/ausadhd/comments/1mhdmgs/foi_250162...

[skissane]

Since last year, lisdexamfetamine sold in Australia has been manufactured in Germany (API) and Ireland (packaging). The DEA has zero jurisdiction over a drug manufactured in Germany/Ireland and then exported from there to Australia–US quotas do not apply, the relevant quotas are the German/Irish/Australian quotas set by their respective governments (which governments appear to take a much more flexible and responsive approach to doing so than the DEA does). Takeda said that GMP issues in the Irish plant were causing supply problems – and I don't see any reason to disbelieve them; GMP is a TGA/FDA/EMA issue not something the DEA has any authority over.

The biggest cause of Australia's lisdexamfetamine supply issues isn't the DEA, it is patent law – the US patent expired in 2023, the Australian patent doesn't expire until 2028, which gives Takeda a continuing near-monopoly on lisdexamfetamine in the Australian market – so if Takeda is having problems meeting the growing demand, it is legally very difficult for other firms to step in. The TGA did for a period allow emergency parallel import – but I don't know if that included generics, and my own experience was it wasn't clear how to even access it – my impression is that for most patients it was more of a theoretical allowance than something practically helpful to them.

I think the biggest thing the DEA is doing here is damaging the US' own pharmaceutical manufacturing industry by pushing controlled substances production out of the US and into friendlier countries in Europe and Asia. The DEA can't cause any lasting issues with controlled substances availability in Australia because their jurisdiction is legally limited to the United States. Even if we suppose the DEA may have temporarily contributed to supply issues in Australia – surely equal blame lies at Takeda for being too slow at moving manufacturing out of the US.

[wahern]

That document is quite confusing, at least when skimming it. There's actually a bullet point on one page that says, "The current interruption to supply is NOT related to any DEA production quotas or restrictions on API."

That may be technically true, or perhaps it's just a false assertion included in the document dump. But AFAIU the issue is that the DEA tightly controls production and distribution of bulk amphetamines. There's just not a global quota, but per manufacturer quotas as well as requirements for allocation for each product. For example, the DEA sets a supply quota for 40mg pill production separate from a 50mg prescription. So if a particular manufacturers supply for 40mg pills is exhausted but they have tons for 50mg pills, too bad unless and until you go through an onerous process with the DEA to reallocate. It gets even worse across manufacturers. If manufacturer A has to shut down their production facility for some reason, manufacturers B and C can't easily pick up the slack. That's because reallocation of amphetamine supply to another manufacturer not only requires navigating a bureaucracy (that the DEA may very well slow walk given their present attitude), but it requires manufacturer A to voluntarily relinquish their quota, which they never do as there's zero benefit to them.

TL;DR: Technically global supply is more than adequate, but DEA rules, which effectively operate extraterritorially, create huge distribution problems. So the DEA can technically claim quotas aren't the problem, but that's at best highly misleading. If manufacturer A has to shutdown production (which, from the document, seems to have been one of the issues with Takeda), the end result is less production even though other manufacturers could theoretically pick up the slack.

[skissane]

> There's just not a global quota,

There is no global quota. There are national quotas set by every country's government. US law nominates the DEA as the agency which does that for the US. Each country's government reports their national quotas to a UN agency (the INCB), but the UN agency has no power over them – at the very worst, they might criticise your quotas, but probably not even that; and more powerful countries (not just the US, even middle powers like Australia) can ignore what UN bureaucrats think with impunity – some poor developing country it may be a different story, especially if aid decisions are tied to getting a "good report card" from those bureaucracies.

And while for the DEA, setting these quotas is part of some grand moral/ideological crusade, for EU governments and Australia it is just technocratic paperwork – so of course those governments approach the issue much more reasonably than the DEA does.

> but DEA rules, which effectively operate extraterritorially, create huge distribution problems.

I don't see how they do. Lisdexamfetamine sold in Australia is manufactured by Takeda in Germany and Ireland. The DEA lacks jurisdiction over what a Japanese company does in EU and Australia. Although the drug was originally developed in the US, the Australian patent is currently owned by the Japanese parent company, not its American subsidiary, while the American subsidiary owns the "Vyvanse" trademark in Australia; anyway, DEA jurisdiction is based on manufacture in the US or US import/export, not country of development or IP ownership.

> If manufacturer A has to shutdown production (which, from the document, seems to have been one of the issues with Takeda), the end result is less production even though other manufacturers could theoretically pick up the slack.

In Australia's case they can't because lisdexamfetamine is still under patent, so other manufacturers are illegal – not because of the DEA, because Takeda will sue them. Takeda could license other manufacturers voluntarily, but why would they do that? That might be great for patients, but probably not so great for their shareholders.

I'm no fan of the DEA, but blaming the DEA for something that happens in Australia appeals to people emotionally even if it isn't true, whereas blaming patent law and the business decisions of a Japanese corporation is more truthful but less emotionally satisfying.