More than a year ago, a Seattle doctor and several cancer patients sued the U.S. Drug Enforcement Administration after the federal agency sent a letter declaring that the patients could not access synthetic psilocybin under federal and state right-to-try laws. These legislations grant patients with terminal illnesses the right to use experimental drugs that haven’t yet been approved for public use. The U.S. Court of Appeals for the Ninth Circuit dismissed the suit in February, stating that it did not have jurisdiction because the letter sent by the DEA wasn’t a final rule.
However, the DEA could soon be sued again over its hardline stance on psilocybin access for patients with terminal cancer. Sunil Aggarwal, a Washington state physician at Advanced Integrative Medical Science (AIMS) first filed a petition to allow terminal cancer patients to use psilocybin as a treatment for severe anxiety and depression in March 2021. The petition’s denial resulted in a court challenge where Aggarwal and his patients argued that the DEA’s stance was not in line with federal right-to-try laws that allowed terminal patients to use experimental medicines.
Even though the challenge was supported by several testimonies, amicus briefs and bipartisan state attorneys general, the U.S. Court of Appeals for the Ninth Circuit dismissed the case on procedural grounds.
A February 2021 letter from the DEA said that the agency had no legal carve out to allow the doctor to acquire psilocybin on behalf of his patients via RTT. Even so, the DEA encouraged Aggarwal and fellow researchers who wanted to study psilocybin to apply for the authorization needed to research Schedule I drugs.
Emerge Law Group special counsel Kathryn Tucker, who is representing the patients behind the lawsuit, said they will seek expedited review if the DEA doesn’t clarify whether its opinion is a final rule or not.
After the appeals court dismissed the suit against the DEA on the grounds that it wasn’t a final rule, attorneys representing the plaintiffs sent the agency a letter asking it if its position on psilocybin access for terminal patients was a final rule. The DEA refused to clarify the point, stating that the request rehashed the points covered in an earlier petition and that the agency had no basis to reconsider its February 2021 letter.
If the DEA doesn’t clarify whether or not its stance is a final rule by this week, the plaintiffs will see the agency’s silence as proof of its ruling’s finality and bring the case back to the appeals court.
The onward march of the psychedelics movement is likely to face a number of obstacles, including federal agencies that want to maintain the status quo at all costs, and it may be quite a while before entities such as Delic Holdings Corp. (CSE: DELC) (OTCQB: DELCF) have the kind of regulatory regime that fosters sector growth while protecting consumers as they use psychedelic medicines in a clinical setting.
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