The Drug Enforcement Administration (DEA) is being sued—again—over its refusal to allow a doctor to treat terminally ill patients with psilocybin therapy pursuant to federal and state “Right to Try” (RTT) laws, which are aimed at expanding access to Schedule I investigational drugs that aren’t currently approved for general use.
In addition to the new lawsuit, DEA is also facing increased political pressure from bipartisan lawmakers, who are taking an extra step to provide additional congressional clarification, filing companion bills in the House and Senate on Wednesday to reaffirm that the scope of Right to Try policy should include psychedelics.
The latest litigation is a follow up to an earlier lawsuit that was heard before the U.S. Ninth Circuit Court of Appeals, which ultimately rejected that case in February on procedural grounds. In essence, the federal court ruled that they could not reach the merits of the challenge because DEA hadn’t made clear that its denial constituted a final rule that could be appealed.
Following that decision, the plaintiffs repeatedly sought clarification from DEA on whether its decision was final. The agency declined to respond to those written requests, so attorneys informed DEA they would give officials until this week to reply, after which point they would consider the decision final and submit another lawsuit.
That suit was filed in the same federal appeals court on Friday. The hope is that the judges will now get to the merits of the challenge, which generally asserts that DEA is unlawfully misinterpreting and misapplying Right to Try statute that should allow terminally ill patients to access Schedule I investigational drugs like psilocybin.
“In denying Petitioners’ requested accommodation in the Final Agency Action, DEA hides behind a smokescreen, neglecting its duty to implement the federal RTT and violating the state RTT,” the complaint says. “It is attempting to use the Controlled Substances Act [CSA] as a cudgel to thwart state medical practice, to the detriment of dying patients.”
While DEA claims that it “has no authority to craft policies to address the RTT,” that assessment is “wrong,” the filing continues. “Just because the DEA chooses not to do something, does not mean that the agency has no authority to do so. Here, the DEA is violating federal law and federalism principles.”
“Petitioners seek review of the Final Agency Decision on the grounds that it is arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law; contrary to constitutional right, power, privilege, or immunity; in excess of statutory jurisdiction, authority, or limitations, or short of statutory right; without observance of procedure required by law; and/or otherwise unsupported by substantial evidence.”
Kathryn Tucker, special counsel at the Emerge Law Group who is representing the plaintiffs, told Marijuana Moment that their “advocacy to open access to psilocybin, an eligible investigational drug intended to be available to those with life-threatening conditions pursuant to the terms of duly enacted state and federal RTT laws, is multi-pronged.”
“We are engaging litigation, supporting federal congressional action and direct citizen engagement,” she said.
“Our clients face the reality of inexorably advancing terminal illness and are burdened with debilitating anxiety and depression, which could be relieved with access to this drug,” she said. “There is real urgency; we are pressing forward as fast we can on every front we can to get them relief, in the face of agency obstruction of the law of the land.”
By getting to the merits, plaintiffs’ expect that the court will agree that current statute mandates that DEA provide psilocybin access to patients in need, which could even make it so there wouldn’t even be an immediate need for new congressional legislation clarifying a law already on the books.
“If I were [a judge on the court], I would find DEA’s reaction to our petition for a waiver frustrating if not downright enraging,” Shane Pennington, an attorney at Vicente Sederberg LLP who is also working the case, told Marijuana Moment. “If, as DEA convinced the Ninth Circuit panel in the earlier litigation, DEA’s initial letter decision wasn’t final but was instead merely the start of the agency’s process, then the agency’s response to our subsequent express request for a waiver should have moved the ball forward in some form or fashion.”
“In treating our petition for a waiver as a request for reconsideration, DEA has effectively confirmed what we’ve been saying all along: The agency’s process is complete and has been for some time,” he said. “DEA has construed the statutes to divest it of authority to accommodate RTT, and that’s that.”
Meanwhile, the new bipartisan companion measures in Congress would make a technical amendment to the text of the existing statute, with the primary purpose of clarifying—in the face of DEA objections—that RTT policy as signed into law by former President Donald Trump already means that patients with terminal health conditions can obtain and use investigational drugs that have undergone clinical trials, even if they’re Schedule I controlled substances.
Psilocybin, along with MDMA, has already advanced in clinical trials and been designated by the Food and Drug Administration (FDA) as a “breakthrough therapy.” Cannabis has also undergone requisite clinical trials.
The bill filing comes about six months after bipartisan members of Congress sent a letter, led by Rep. Earl Blumenauer (D-OR), requesting that DEA allow terminally ill patients to use psilocybin as an investigational treatment without the fear of federal prosecution.
This isn’t the first time that Congress has taken DEA to task over what they view as an unnecessarily languid approach to rulemaking. For example, a bill enacted under the Obama administration—the “Improving Transparency in Medical Therapies Act”—specifically imposed strict deadlines for DEA to approve registrations for scientists who seek to conduct clinical drug trials in a timely manner.
Meanwhile, in May, Sens. Cory Booker (D-NJ) and Brian Schatz (D-HI) separately pushed top federal officials to provide an update on research into the therapeutic potential of psychedelics, arguing that ongoing federal prohibition has stymied studies.
Federal health officials recently recognized that federal prohibition makes it harder to study the benefits of psychedelics, requiring researchers to jump through additional regulatory hoops.
Activists—including one of the plaintiffs in the RTT case, Erinn Baldeschwiler—staged a demonstration outside of DEA headquarters in Virginia in May, demanding that the agency allow terminally ill patients to access psilocybin therapy.
DEA is separately being sued over repeated delays in processing requests for public records related to psychedelics and marijuana.
Additionally, DEA recently announced that it is taking the rare step of holding a hearing on its controversial proposal to place the five psychedelic compounds in Schedule I of the Controlled Substances Act.
The agency first proposed scheduling the tryptamines—4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET and DiPT—in January. And it faced significant pushback from the research and advocacy communities, receiving nearly 600 messages during a public comment period, with most opposing the rule change and requesting a hearing.
DEA’s own administrative court subsequently agreed that there was a need to hold a hearing on the matter before the prohibition could be enacted.
The agency has separately increased production quotas for the production of certain psychedelics like psilocybin in an effort to promote research, but its scheduling decisions have continued to represent obstacles for scientists.
Read the text of the lawsuit against DEA over psilocybin access below:
Image courtesy of Kristie Gianopulos.