This feature is part of a collaboration between MUD\WTR and DoubleBlind to investigate what access to psychedelic-assisted therapy might look like after federal approval. DoubleBlind is a biannual print magazine and media company covering timely, untold stories about the expansion of psychedelics around the globe.
Once you’re done here, head over to DoubleBlind and get stuck into MDMA Therapy is Almost Legal—But Who Will Have Access?
When President Richard Nixon signed the Controlled Substances Act (CSA) in 1970, psychedelics like psilocybin, LSD and mescaline were blacklisted as Schedule 1—the U.S. Drug Enforcement Administration’s (DEA) strictest category—tarnishing their already notorious public image and largely cutting them off from research. And there they have remained to this day.
Is it possible that they’ll ever leave Schedule 1? The short answer is: Yes, but it’d be a (very) delicate process.
Schedule 1 is like a maximum-security prison; once drugs go in, they tend not to come out for a long time. The DEA reserves its top drug-scheduling category (there are five in total) for those drugs “with no currently accepted medical use and high potential for abuse,” according to the agency’s website. Heroin is currently in Schedule 1, as is MDMA. The next rung on the ladder, Schedule 2—intended for drugs with high potential of abuse and some kind of accepted medical use—includes cocaine, oxycodone, and methamphetamine. Yes, there’s a version of meth (called Desoxyn) that can be prescribed by doctors.
It’s possible for a Schedule 1 substance to be rescheduled (moving it to lower schedules, which would slacken criminal penalties and expand access to research) or “decontrolled” entirely (declassifying it as a controlled substance altogether), but it’s rare. Even cannabis, which is now legally available in one form or another in 19 states, remains in Schedule 1. In 2018, the Food and Drug Administration (FDA) approved a pure-cannabidiol (CBD) drug called Epidiolex for the treatment of some severe cases of epilepsy, but the actual cannabis plant from which it’s derived—along with the plant’s many other potentially therapeutic cannabinoids—is still strictly illegal at the federal level.
In a 2020 document titled Drugs of Abuse: A DEA Resource Guide, the DEA states explicitly that “if a drug does not have a potential for abuse, it cannot be controlled.” However, research has shown that—far from having “potential for abuse”—psilocybin holds promise for substance use. The DEA gets around that by using a rather expansive definition for “potential for abuse.” Here’s one criteria: “Individuals are taking the drug or other substance on their own initiative rather than on the basis of medical advice from a practitioner.” If we’re playing by that rule, then just about every household drug that one can name—caffeine, for example, or Ibuprofen—should be a federally controlled substance.
There are also examples of substances which may cause distortions and other visions similar to classic psychedelics, but for one reason or another have not been scheduled. For example, nutmeg, in addition to being a spice that can be purchased at just about any store, can cause tachycardia (an accelerated heart rate) and hallucinations at sufficient doses, yet it’s nowhere to be found in the drug schedules. Neither is the psychedelic Salvia divinorum.
The point is that the DEA’s drug scheduling process can be messy, and sometimes arbitrary.
The Main Road: Clinical Trials and FDA Approval
The most common pathway down or off the DEA’s drug schedules is through the rigorous, three-phase clinical trial process, followed by the approval of the Food and Drug Administration (FDA). Clinical trials are staggeringly expensive, averaging around $2 to $3 billion for developing a new drug, according to a 2018 study from the Johns Hopkins Bloomberg School of Public Health.
Leading pharmaceutical companies—some of which rank among the wealthiest brands in the world—are often willing and able to foot the bill, incentivized largely by the twin prospects of being able to secure patents and market exclusivity, which together can produce a significant ROI. No such incentives exist for the research of compounds which exist in the public domain such as psilocybin, unless they can tweak the compound to qualify it for patent (à la COMPASS Pathways—more on that in a moment), or get exclusivity on some other aspect of the treatment such as a novel delivery system (think: a psilocybin transdermal patch). Most major pharmaceutical companies aren’t going to spend billions on research and development of synthetic psilocybin, when psilocybin-containing mushrooms are already bountifully available through the black market.
As a result, compounds in the public domain—even those with demonstrated medical or therapeutic potential—are often simply ignored by big pharma.“That’s the main problem with our current controlled substance policy. It disincentivizes research of the most obviously useful substances,” says Shane Pennington, an attorney who specializes in federal cannabis and psychedelics law. “It's better at preventing research than it is at preventing abuse and diversion, which is absurd.”
Given those barriers, it’s unlikely that psilocybin will be removed from Schedule 1 via the main road of clinical trials and FDA approval anytime soon.
But as was proven with Epidiolex, it’s possible to reschedule in baby steps. Psilocybin might remain in Schedule 1 for the foreseeable future, but specific formulations of the compound may (soon) be rescheduled. There are currently a number of psychedelic research companies that are working on such formulations, attached to carefully devised therapeutic protocols, incentivized the old fashion way: by patents and market exclusivity. COMPASS Pathways’ COMP360, for example—a patented, synthetic psilocybin formula designed to address treatment-resistant depression expected to enter Phase 3 clinical trials next year—could ultimately receive FDA approval, even if psilocybin remains straitjacketed in Schedule 1. Essentially, what this means is that COMPASS’ formulation of synthetic psilocybin, along with its therapy, may be in a different schedule, even if psilocybin is not.
“The way that drug policy works now is that they move it one formulation and molecule at a time,” Pennington says. “They’re not moving the whole plant [or the whole mushroom] ever … basically, these naturally-occurring substances are on lockdown, presumably forever, unless there’s legislation to change it.”
The Side Roads: Legislation, the San Pedro Theory and Lawsuits
There are a few alternative potential pathways that could eventually lead to psilocybin being rescheduled.
The first (and by far the simplest) pathway would be through Congress, which, as attorney and controlled substances litigation expert Matthew Zorn points out, “can do whatever the hell it wants.” Like amend the Controlled Substances Act, for example. Many legal experts say the chances of this happening are basically zero. “Congress can't even get its act together to figure out what it wants to do with cannabis, which it’s been trying to figure out for a decade,” says Mason Marks, a law professor at Florida State University who also recently published an op-ed in Scientific American called “A Strategy for Rescheduling Psilocybin.” “There's been literally dozens of bills proposed to reschedule cannabis, and it just doesn't happen.” (He does note in his article, however, that Congress could eventually be swayed to amend the CSA as bipartisan support for psychedelic research grows.)
Zorn also has a theory that psilocybin-containing mushrooms have not even technically been scheduled by the DEA. “Psilocybin [the molecule] is obviously in Schedule 1,” he says. “But I have this idea that in the same way you can go to Home Depot and buy a San Pedro cactus … why would it be any different with a psilocybin mushroom?” He emphasizes that this is just a theory and in no way should be mistaken for legal advice. Still, it illustrates the legal messiness and ambiguity surrounding much of current federal drug policy, the blurry lines which separate a harmless garden plant from contraband. (Anyone who’s interested in learning more about this is advised to read Michael Pollan’s essay on opium from his latest book, This is Your Mind On Plants.)
Another potential route is to petition the DEA—submit an argument for why psilocybin should be rescheduled. This is precisely the step that was taken by Zorn, Pennington, and their co-counsel Kathryn Tucker in February, when they submitted a petition to the agency to move psilocybin from Schedule 1 to Schedule 2.
The process leading to that petition began back in January 2021, when Tucker and her colleagues approached the DEA on behalf of Seattle physician Sunil Aggarwal of the Advanced Integrated Medical Science (AIMS) Institute, who was seeking psilocybin to treat terminal cancer patients suffering from debilitating depression and anxiety. The lawyers invoked the 2018 federal Right to Try (RTT) Act, which according to the FDA’s website enables “patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial to access certain investigational treatment options.”
That request was denied by the DEA, ushering in a lengthy federal court case, the lawyers’ petition to reschedule psilocybin, and finally—in August and September 2022, respectively—a denial from the DEA either to grant access to psilocybin under RTT law, or to reschedule psilocybin. On October 10, the AIMS team responded by opening a new case challenging the agency’s decision to deny the rescheduling petition. A win in this case is the team’s current priority: “A favorable outcome in the rescheduling litigation, leading to rescheduling of psilocybin off of Schedule I, would remove the barrier to RTT access,” Tucker says.
There are reasons for the AIMS plaintiffs to feel hopeful. While some states, such as Missouri, have their own RTT laws which specifically exclude Schedule 1 substances, no such language, according to Tucker, exists in the federal RTT law. In July, Senators Cory Booker (democrat, NJ) and Rand Paul (republican, KY) introduced the Right to Try Clarification Act, which seeks to establish unequivocally that Schedule 1 substances, particularly psilocybin and MDMA, can’t be excluded from RTT law. And just last month, President Biden ordered the Departments of Justice and Health and Human Services “to review expeditiously how marijuana is scheduled under federal law,” possibly creating a precedent which could pave the way to rescheduling other controlled substances (including psilocybin) in the future.
The DEA declined to comment for this story.
The Magic Road: Rescheduling by Default
Pennington, a passionate supporter of Right to Try, is also concerned about a potential backlash. “The better it works, the less likely it is to be a sustainable solution,” he says. He recalls the case of Robert Randall, who in 1976 became the first person in the US to be granted the right to use medical cannabis for the treatment of his glaucoma. According to Pennington, his approval from the US government was followed by a huge influx of similar requests, eventually forcing the FDA and the DEA to shut down the expanded access program that had been launched by his case. The best argument against the AIMS case, Pennington says, is that “it would potentially open up the floodgates.”
On the other hand, he points out that another floodgate might be opened: As cases like AIMS and city- and state-level initiatives (like decriminalization efforts and the upcoming ballot to legalize facilitated psilocybin sessions in Colorado) continue to make headway, psilocybin could eventually reach a critical threshold in which federal law enforcement simply doesn’t have the resources—or perhaps even the willpower—to go after it. This is, more or less, where the country currently stands with cannabis. “[The] DEA just doesn't have the budget to stop it, even if it wanted to,” says Pennington. “And so by this bizarre default, it's become effectively legal—without rescheduling.”
Something similar, Pennington speculates, could happen with psilocybin. “If enough people believe it's magic, maybe it's magic … you don't always have to go through the formal procedures if everybody believes something to be the case.”
Webb Wright is a journalist based in Brooklyn, New York who covers psychedelics and Web3. Follow him on Twitter.
This feature is part of a collaboration between MUD\WTR and DoubleBlind to investigate what access to psychedelic therapy might look like after federal approval. DoubleBlind is a biannual print magazine and media company covering timely, untold stories about the expansion of psychedelics around the globe.
Now that you’ve finished reading Webb’s investigation, head over to DoubleBlind and get stuck into MDMA Therapy is Almost Legal—But Who Will Have Access?