By: Kathryn Tucker, JD[1]
Background
We have been leading efforts to open access to the investigational psychedelic drug psilocybin for therapeutic use for patients with life threatening illness through state and federal Right to Try (RTT) laws.[2] RTT laws recognize that these patients do not have the time to await the slow process of new drug approval to be completed and allow access so long as an investigational drug meets certain criteria, including that it has successfully completed a Phase I clinical trial and remains under investigation.
On behalf of Dr. Sunil Aggarwal, a Seattle palliative care physician, and a number of his patients with advanced cancer, we contend that RTT laws provide that these patients ought be able to access psilocybin for therapeutic use now, before completion of later stage clinical trials or the long process of rescheduling.[3] Psilocybin meets the requirements of RTT laws to be deemed an ‘eligible investigational drug’; under the letter and spirit of these laws, it is intended to be available for this population of patients while still under investigation.[4]
This advocacy effort seeks to open a path for access to psilocybin (and potentially other investigational psychedelic drugs, including MDMA) for therapeutic use, bringing a powerful new palliative care tool to relieve debilitating non-physical suffering for those with life-threatening conditions.
The Federal Litigation on the Scope and Application of RTT Laws
Dr. Aggarwal was denied permission to access psilocybin for therapeutic use by the DEA in early 2021. He then filed suit in the Ninth Circuit Court of Appeals in early 2021 asserting the DEA had the obligation to accommodate RTT as the law of the land. The court declined to reach the merits, ruling that the DEA’s rejection of the request for access was not sufficiently ‘final’ to enable judicial review.[5] Following that ruling in January 2022, we submitted both a Petition Requesting Waiver, to elicit a sufficiently final decision to enable judicial review, if necessary, and a Petition to Reschedule psilocybin from Schedule I to Schedule II.[6] On June 28, 2022, the DEA again rejected access to psilocybin pursuant to RTT in response to the Petition Requesting Waiver. Accordingly, we return to the Ninth Circuit, seeking assignment to the same three-judge panel, to reach the merits and ask the court to compel the DEA to accommodate RTT.
The Freedom of Information Act (FOIA)
Due to the DEA’s failure to timely respond to these Petitions, we filed a number of Freedom of Information Act (FOIA) requests related to its handling of the Petitions, seeking disclosure of documents which would provide reasoning for such failure. These FOIA requests were labeled “unusual” and “complex”, despite their narrowness; accordingly, we have filed a lawsuit challenging the DEA’s unlawful pattern and practice in labelling virtually all FOIA requests in this manner, which subverts good government and principles of transparency pertinent to the operations of federal government agencies.
An amendment to the federal RTT has been introduced in the US Congress to make abundantly clear that eligible investigational drugs which are Schedule I substances are to be accessible pursuant to RTT, notwithstanding any prohibitions on dispensation, use, transportation, and distribution in the Controlled Substances Act.[7]
[1] Special Counsel at Emerge Law Group, Co-Chair Psychedelic Practice Group. Founding board member of the Psychedelic Bar Association, Co-Chair, Litigation and Advocacy Committee. Liaison to the American Bar Association. Founding Advisory Board Member, the Initiative on Psychedelics and Healing, Global Wellness Institute.
[2] These laws have been adopted by 41 states and the U.S. Congress. A tremendous efficiency of this advocacy is that it takes advantage of and utilizes the benefit offered by these already existing laws. To give some perspective: enactment of a single state law to open access to psilocybin in a state with a relatively small population costs approximately $5M (e.g. Oregon M109, 2020).
[3] Media interest in the case: https://www.truffle.report/seattle-doctor-lawyer-speak-out-on-landmark-dea-psilocybin-lawsuit/; https://www.seattletimes.com/seattle-news/health/new-legal-push-in-washington-state-aims-to-speed-magic-mushrooms-to-dying-patients/; https://www.marijuanamoment.net/8-states-side-with-cancer-patients-in-psilocybin-mushroom-lawsuit-against-dea/; https://www.scientificamerican.com/article/two-cancer-patients-battle-to-make-psilocybin-accessible-for-palliative-care/ ; https://www.ourmbclife.org/episodes/psilocybin-assisted-therapy-legal-and-advocacy
[4] For more extensive discussion about RTT laws and their application to psilocybin see https://emergelawgroup.com/avenues-to-access-psilocybin-therapy-in-oregon-a-new-palliative-care-tool-for-patients-suffering-anxiety-and-depression/; https://emergelawgroup.com/nations-first-legal-challenge-to-allow-psilocybin-therapy-in-end-of-life-care-under-right-to-try-laws-moves-forward/
[5] Advanced Integrative Med. Sci. Inst., PLLC v. Garland, 24 F.4th 1249 (9th Cir. 2022).
[6] Both can be reviewed here: https://emergelawgroup.com/establishing-a-pathway-to-access-psilocybin-for-use-with-patients-with-advanced-illness-update/.
[7] The “Right to Try Clarification Act”.
