The Drug Enforcement Administration (DEA) has again rejected a petition to reschedule psilocybin and a doctor’s request for a federal waiver to obtain and administer the psychedelic to terminally ill patients, prompting a new set of legal challenges in federal court.
Sunil Aggarwal, a Washington State-based palliative care specialist, has been fighting DEA for psilocybin access for over a year. But the agency has denied his petition to place the substance in a lower drug schedule, as well as the doctor’s waiver request under federal “Right to Try” (RTT) law.
The most recent rescheduling denial was handed down in a letter last month, with DEA saying that the Food and Drug Administration (FDA) has not authorized psilocybin as a medicine and so it must remain in Schedule I of the Controlled Substances Act (CSA).
The letter doesn’t directly address the key point of the rescheduling petition, which is that FDA has designated the psychedelic as a “breakthrough therapy” for severe depression.
Attorneys filed a challenge to the rescheduling petition denial in the U.S. Court of Appeals for the Ninth Circuit last week. Opening briefs are due from the petitioners in January 9 and the respondents by February 7.
In a separate but related complaint, attorneys for Aggarwal petitioned the same court last month to review DEA’s denial of a request for a federal waiver to allow the doctor to access psilocybin to treat anxiety and depression in his severely ill patients.
Aggarwal, who serves as co-director of the Advanced Integrative Medical Science (AIMS), says federal RTT statute makes clear that seriously ill people qualify for investigational drugs, including psychedelics in Schedule I of the CSA.
But DEA says that, because the RTT law only explicitly discusses exemptions under the Federal Food, Drug, and Cosmetic Act (FDCA), it doesn’t have implications for the CSA. Plaintiffs contend that that’s not the case, as CSA has a section that says DEA can’t interpret the drug law in a way that conflicts with the FDCA.
The agency previously rejected a RTT waiver request last year, which resulted in litigation in the same federal court. But the court rejected the case on procedural grounds in February, with judges saying 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.
Plaintiffs then made repeated attempts to get DEA on record about whether it had made a final rule. The agency didn’t give a clear answer for months, but it finally confirmed that its decision was “final” in a letter that was dated in September and received by Aggarwal this month.
After receiving that confirmation, the petitioners pulled their earlier legal challenge and filed a new request for a review last week.
“As part of the team working to open access to psilocybin for therapeutic use, we are pleased to have elicited a prompt, clear and appealable denial of the psilocybin rescheduling petition,” Kathryn Tucker, director of advocacy for the National Psychedelics Association who has been involved in the psilocybin litigation, told Marijuana Moment last week.
“We will take our very strong arguments that psilocybin does not belong on Schedule I into court and look forward to a successful outcome there,” she said. “Through the RTT litigation and this new suit challenging the refusal to initiate rescheduling proceedings, we are pressing forward to open access, knowing that those with life-threatening conditions could be benefited with this therapy.”
DEA is also facing increased political pressure from bipartisan lawmakers, who recently took an extra step to provide additional congressional clarification, filing companion bills in the House and Senate in July to reaffirm that the scope of RTT policy should include Schedule I drugs like psilocybin.
The legislation 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.
The bills were filed 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.
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.
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Booker posted a video last week where he talked about how psychedelics like psilocybin are strictly controlled under federal law as Schedule I drugs, which places “a lot of limitations” on them.
“But at the same time, we’re having massive breakthroughs in a lot of the research,” he said, noting psilocybin and MDMA specifically “are showing incredible results for helping people with PTSD, with trauma, even with anxiety and depression.”
Meanwhile, as part of their efforts to better understand DEA’s administrative process, Aggarwal and his counsel have submitted several Freedom of Information Act (FOIA) requests for relevant documents. They’ve previously accused the agency of using deliberate delay tactics in processing those requests—the subject of another lawsuit.
After asking for records related to both the RTT case and a separate rescheduling petition under FOIA law, the agency responded by designating the request as “commercial” and asking for $11,740 up front to cover initial processing. Aggarwal and Tucker strongly contested the idea that there’s a commercial motivation to the case, and they’ve appealed the categorization, so far to no avail.
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.
In a procedural win for scientists and advocates, DEA recently retreated on a proposed ban on psychedelic compounds that experts say have research value. The development came just one month after the agency abandoned separate plans to place five tryptamine psychedelics in Schedule I.
DEA faced significant criticism over the latter proposal, receiving nearly 600 messages during a public comment period, with most opposing the rule change and requesting a hearing. The agency’s own administrative court subsequently agreed that there was a need to hold a hearing on the matter before the prohibition could be enacted—but DEA pulled the proposal instead.
Separately, DEA recently said that it wants to more than double the amount of marijuana that can be legally manufactured for research in 2023—and it’s also seeking to significantly increase the quota for the production of psychedelics like psilocyn, LSD and mescaline.
Read DEA’s responses to the petitions for a psilocybin rescheduling review and a RTT waiver below:
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The post DEA Faces New Legal Challenges Over Denying Psilocybin Rescheduling Petition And Doctor’s Federal Waiver Request appeared first on Marijuana Moment.