[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.