In November 2023, the Foundation wrote to the United States Drug Enforcement Administration (DEA), asking them to increase the Lisdexamfetamine quota to help address global drug shortages.
The work of the ADHD Foundation isn’t just limited to our national helpline and community support – did you know we also deliver meaningful advocacy for our community?
The DEA sets annual aggregate production quotas on controlled substances like Lisdexamfetamine. This is the active ingredient in one of two long-acting ADHD medications registered in Australia. The DEA originally proposed to set the production quota for 2024 at the same level as 2023.
Following advocacy by the Foundation, the DEA revised the annual quota in September 2024. The decision specifically called out the work of Australian organisations ADHD – particularly the ADHD Foundation – in sounding the alarm about ongoing frustration in accessing critical medicines.
We’re pleased that the Foundation’s submission led to the DEA seeking further information to more accurately forecast global demand for Lisdexamfetamine, and that the DEA referenced our work in their recent decision.
We hope that the 24 per cent increase in the manufacturing quota – 75 per cent of which will be allocated to meet foreign demand for finished products – will make a real difference to Australians and the global ADHD community.
While the severe shortages experienced by Australians in 2023 and 2024 were not the result of the DEA’s previous quota decisions, the ADHD community had held serious concerns that the current quota would not meet the international increase in diagnosis and prescribing.
Our most recent analysis of Department of Health data shows that prescriptions of Lisdexamfetamine increased by over 350% in Australia between 2019-20 and 2022-23.
While generic products could enter the US market from 2023 – taking a share of the annual aggregate production quota – Lisdexamfetamine is still covered by a patent in Australia, with limited alternatives for patients.
The ADHD Foundation is a small, volunteer-run organisation that doesn’t receive any government funding. We provide significant benefits to the community through our free national helpline, as well as our advocacy on behalf of people with ADHD.
While we are still waiting for further details of how this decision will impact the availability of medicines approved in Australia, the Foundation hopes that this outcome will provide some relief for Australians relying on long-acting medication to manage their ADHD.
Our submission can be found here.
Takeda’s Update to the Foundation
“We would like to take this opportunity to thank you for your submission to the DEA advocating for this increase. Submissions from Australia were specifically referenced in the formal notice of the increase and formed part of the DEA’s analysis to determine whether an increase was required.
We do not yet know the details regarding Takeda’s allocation and what this means for Australia. Given the long lead times due to the complexity of production, it will take some time before we receive stock from any additional allocation. We will let you know when we have further clarity on the details for Australia, including possible timeframes.”