As counsel to Dr. Sunil Aggarwal of the Advanced Integrative Medical Science (“AIMS”) Institute we have been seeking authorization for him to obtain the investigational drug psilocybin under the Washington and federal Right to Try (“RTT”) Acts for therapeutic use with his patients with advanced cancer. RTT laws recognize that patients with life-threatening illness do not have the luxury of time to await the completion of the long slow process of new drug approval, and create a path to access investigational drugs which have completed a Phase I clinical trial and remain under investigation.[1]
Psilocybin has shown enormous promise in early clinical trials in relieving debilitating anxiety and depression suffered by terminally ill patients. Psilocybin is currently listed on schedule I of the Controlled Substances Act (“CSA”); accordingly, no supplier would provide psilocybin to Dr. Aggarwal without DEA’s permission. When we sought DEA’s guidance in January 2021 regarding how he might obtain necessary approval, DEA responded, in February 2021, that it had no authority to waive any of the CSA’s requirements and allow access.
On Dr. Aggarwal’s behalf we sought judicial review of that determination in the United States Court of Appeals for the Ninth Circuit. The court dismissed the case on January 31, 2022, concluding that DEA’s action was not “final” for purposes of judicial review under 21 U.S.C. § 877. AIMS v. Garland, 21-70544 (9th Cir. Jan. 31, 2022). This dismissal for lack of jurisdiction did not address the merits of petitioners’ claims, which remain strong.
Dr. Aggarwal and AIMS have subsequently taken two steps with DEA to move this matter forward.
First, on February 2, 2022 a Petition to Reschedule psilocybin from schedule I to schedule II was filed. The continued placement of psilocybin on schedule I has been described as “absolutely absurd” by one of the nation’s leading researchers of this investigational drug.
Second, Petitioners have asked DEA for a waiver from registration requirements which would allow access to psilocybin for therapeutic use under state and federal RTT laws. The waiver request could be acted upon relatively quickly and should be in light of the urgency patients face with advancing terminal illness. The rescheduling petition will likely take longer but ought not languish.
Keen bipartisan congressional interest in seeing the DEA find a way to accommodate RTT has been expressed. This interest may well catalyze congressional oversight of the DEA’s handling of the Rescheduling Petition.
The fight to open the pathway intended by state and federal RTT laws continues, with the objective of making psilocybin available for therapeutic use with patients suffering debilitating anxiety and depression in the face of life-threatening illness.
[1] See RCW 69.77 et seq. (Washington RTT); Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, Pub. L. No. 115-176, § 1, 132 Stat. 1372, codified at 21 U.S.C. § 360bbb-0a (Federal RTT).
