As some of us draw up our wishlists for Santa’s perusal (though, apparently Saint Nicholas has been found a little worse for wear in Turkey), some psychedelics insiders are noting down their hopes for the incoming Trump administration.

Since the U.S. elections last month, I have been speaking with people from all corners of the psychedelics field to better appreciate what they’re hoping the new government might actually do when it comes to psychedelics-related issues.

Here’s a shortlist…

Right to Try and Expanded Access

• A common MVP (minimum viable policy, if you will) mentioned by insiders is enhancing access to psilocybin and MDMA via the federal Right to Try Act.
• That Act allows patients diagnosed with a life-threatening condition who have exhausted existing treatment options to access certain investigational drugs.
• However, the Drug Enforcement Administration (DEA) has prevented patients from accessing Schedule I drugs like psilocybin and MDMA through this process (see, for example, AIMS v. DEA).
• Some advocates and lawmakers have sought to rectify this situation by introducing a clarification act, which would specify that access to schedule I substances should also be considered under the pathway.
• Insiders hope that efforts to shore up the accessibility of psychedelics through this route might firm up during the next administration.
• Expanded access programs were discussed in a similar vein, with some describing them as approximating a real-world trial.

A ‘Cole Memo’ for State-Regulated Psychedelics

• Another common wishlist item is some sort of agreement from the federal government to not interfere with state-regulated psychedelics programs.
• In some ways, that would be similar to the Cole Memorandum issued in 2013 by Deputy Attorney General James Cole under the Obama administration. That memo said that, given its limited resources, the Department of Justice did not intend to enforce its federal prohibition of marijuana in those states that had adopted more liberal policies, except in certain circumstances. That was a boon for state-regulated programs, which could operate without the federal government and its agencies breathing down its neck quite so threateningly.
• But, psychedelics advocates are hoping for something a little firmer than a memo, which didn’t really have any true legal clout.
• Getting something into law, then, would be better. In late 2023, California Democrat Robert Garcia introduced the VISIONS Act, which would have prohibited the use of federal funds to prosecute state-legal psilocybin use (see our September 2023 coverage for more). Advocates are hoping a new administration might put something similar into law.
• It’s unclear how amenable the incoming administration will be to this. Of course, Republicans have focused on ‘states’ rights’, especially in recent policy decisions around thorny issues like abortion laws. But it is worth remembering that Jeff Sessions, Trump’s Attorney General during his first term, abruptly nixed the Cole Memo.

Concessions at the FDA

• Insiders also hope to see psychedelics-related concessions at the FDA, with a whole wishlist of its own in that regard.
• Some hope the agency will simply reverse its rejection of Lykos Therapeutics’ MDMA-assisted therapy New Drug Application (NDA), though that was not expressed as a realistic expectation by many.
• Outside of revisiting specific decisions, some insiders told me they hope the FDA will change how it weights different elements of trial design and results when making decisions on whether to approve drugs.
• Several people told me that they hope to see the agency focus less on functional unblinding and durability, for example.
• Others hope to see the agency shift more of its data requirements and review to the post-marketing environment, allowing drugs to come to market on the basis of a characterised safety profile and perhaps only a signal of efficacy.
• (We have discussed these topics previously, such as in Psychedelic Drug Development Under Trump 2.0: Health Nominees Signal Uncertain Future and Tripping Over Trump: Will the New Administration Embrace Psychedelic Exceptionalism or ‘Just Say No’?)

NIH Funding for Psychedelics

• As we covered recently, some researchers in the field are concerned about the future of NIH funding for psychedelics projects, which has become an increasingly important source of cash for both preclinical and clinical work…