How Could US Psychedelic Regulation Changes Impact the UK Life Sciences and Healthcare Sectors?
Brevia Health has examined recent developments in Psychedelic and other psychoactive substance regulation in the USA and how this could impact the UK. If you require more detailed insight on drug regulation and how it could impact your organisation, please contact Brevia Health (+44 (0)20 7091 1655 or email contact@breviahealth.com). For a full list of support options, please visit our services page.
The US President, Donald Trump, has signed an executive order that will speed up access to treatments for patients with serious mental illness.
On 18 April 2026, President Trump signed the Executive Order ‘Accelerating medical treatments for serious mental illness’[1] which directs federal agencies to speed up research, regulatory review, and access pathways for psychedelic therapies. The order specifically targets drugs like ibogaine, which are currently classified as Schedule 1 substances, meaning they are considered high-risk with no accepted medical use.[2]
This builds on previous developments made under the Trump administration, including an executive order signed on 18 December 2025 to increase medical marijuana and cannabidiol research.[3] This similarly committed to the removal of barriers to research and access for medicinal marijuana-based products.
How is Psychedelic Regulation Changing in the USA?
The new executive order instructs action in four key areas:
- The provision of ‘Commissioner’s National Priority Vouchers’ (CNPV) to appropriate psychedelic drugs that have received a ‘Breakthrough Therapy’ designation. This aims to cut the ‘New Drug Application’ (NDA) review for FDA licensing from 10-12 months to 1-2 months.[4]
- Expedite the process of rescheduling away from Schedule I for substances that have successfully completed Phase 3 clinical trials for serious mental health disorders if appropriate.
- The FDA is directed to ‘facilitate and establish’ a pathway for eligible patients to access psychedelic drugs under the ‘Right to Try Act’. This covers investigational drugs which have completed Phase 1 clinical trials, but have not yet been approved or licensed by the FDA for any use. There must be an application for the drug filed with the FDA, or must be under investigation in a clinical trial that is intended to form the primary bases of a claim of effectiveness.[5]
- To provide funding for State governments ‘that have enacted or are developing programs to advance psychedelic drugs for serious mental illness’. At least $50 million is to be allocated.
What Can We Learn From the Cannabis Rescheduling Timeline in the US?
Cannabis Rescheduling Timeline
- In April 2026, the US Attorney General signed a final rule moving products sold under state medical cannabis licenses, along with FDA-approved cannabis products, from Schedule I to Schedule III.[6]
- This followed an executive order issued on 18 December 2025 directing marijuana to be rescheduled, meaning the process took approximately 4 months.
- However, there is an important distinction between cannabis and psychedelics. When the cannabis rescheduling came into effect, cannabinoid products with FDA approval already existed. There are currently no psychedelics with full FDA licensing.
- The first FDA approval for psychedelic treatments would need to happen before the Drug Enforcement Administration (DEA) considers rescheduling, making the process longer than that seen with cannabis.
Schedule II or III:
- It has not yet been officially confirmed which schedule FDA-licensed psychedelics will fall under; placement is determined by risk of abuse.
- An authoritative review conducted by Johns Hopkins University assessed the risks of psilocybin against the Controlled Substances Act and concluded it should not warrant a Schedule II classification.[7]
- Esketamine, a psychedelic-related drug with FDA approval for the treatment of treatment-resistant depression, is a schedule III controlled substance. The choice of schedule for psilocybin may therefore be similar.
Scope:
- Forty states in the US had already legalised the sale and use of marijuana for medical purposes before the DEA rescheduling.
- It therefore rescheduled not only FDA-approved products, but those which ‘are subject to a state-issued license to manufacture, distribute and/or dispense marijuana or products containing marijuana for medical purposes’[8].
- This is a particularly noteworthy approach that departs from how substances have previously been controlled within Federal Law.
- There are currently far fewer states which have licensed psychedelic programs, and for those which do it is a recent development.[9]
- It would be reasonable to assume future psychedelic rescheduling will only cover FDA-approved products, rather than incorporating state licensing.
Category-based rescheduling:
- The wording of the final rule appears to create a category that future marijuana-containing products which are granted FDA approval can automatically fall under.
- If this same approach is taken for psychedelics, future delays from individual rescheduling processes will be avoided.
How will USA policy impact the UK?
The Executive Order will have no immediate direct effect on the United Kingdom, given this is domestic USA federal legislation and there is no evidence the USA is currently pushing for regulatory alignment with other nations. Yet there are many ways in which this may influence the future of UK drug control:
- The final rule on cannabis rescheduling articulates that the reclassification of cannabis in the USA does not contradict their obligations under the UN Single Convention on Narcotic Drugs 1961. Because the US is a world leader in global narcotics control, this argument could encourage other countries to do likewise without fear of being seen to contradict UN treaties.
- There have been calls in the UK for less stringent drug control, particularly for substances with potential medical benefits. Supporters often point to countries like the Netherlands, Portugal and Canada as examples of more relaxed drug policies, although critics say these arguments are politically motivated and focus on perceived ‘liberal’ approaches to drug control. The current administration in the US, supporting medical psychedelic research and access, could strengthen claims from advocacy groups as evidence that the current approach of the UK is becoming outdated.
- This Executive Order will expand both the number of clinical trials for psychedelics in the US and their general medical use. This will provide a much larger body of evidence for the MHRA and NICE to consider when evaluating the medical benefits and risks of these substances, which are currently under Schedule 1 in the UK.
- This development provides key opportunities for companies within the UK life sciences sector to expand their involvement in the psychedelic space – but while these substances remain tightly controlled in the UK, these operations will have to occur on US soil.
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[1] The White House, ‘Accelerating medical treatments for serious mental illness’, 18 April 2026, Link
[2] The White House, ‘Fact Sheet: President Donald J Trump is Accelerating Medical Treatments for Serious Mental Illness’, 18 April 2026, Link
[3] The White House, ‘Increasing medical marijuana and cannabidiol research, 18 December 2025, Link
[4] FDA, ‘FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests’, 17 June 2025, Link
[5] FDA, ‘Right to Try’, 12 December 2024, Link
[6] Federal Register, ‘Schedules of Controlled Substances: Rescheduling of Food and Drug Administration Approved Products Containing Marijuana From Schedule I to Schedule III; Corresponding Change to Permit Requirements’, 28 April 2026, Link
[7] Johns Hopkins University, ‘The Abuse Potential of Medical Psilocybin According to the 8 Factors of the Controlled Substances Act’, 1 November 2019, Link
[8] Congress.gov, ‘Department of Justice Eases Control of Medical Marijuana, 30 April 2026, link
[9] Soul Syndicate, ‘Legal Status Tracker’, April 2026, Link
