A group of terminally ill patients seeking psilocybin therapy will likely take the Drug Enforcement Administration (DEA) to federal court once again over the agency’s denial to grant access to the treatment under Right To Try (RTT) laws, The Microdose reported.
The Right to Try Act is a 2018 federal law that permits people with life-threatening illnesses to try investigational drugs that have made it past Phase 1 clinical trials. Forty-one states have also enacted Right to Try at the state level.
As reported by Rachel Nuwer in Scientific American, litigants are not the first cancer patients to use Right to Try to access an investigational drug. Yet they do seem to be the first to try using it for treatment with a Schedule I drug. As such, their doctor attempted to obtain DEA permission to access and administer psilocybin.
Cancer patients suffering from severe anxiety and depression have been in this struggle for almost two years now. Following a 2021 letter from their lawyers to the DEA, the agency replied that the RTT laws do not exempt drugs (including psilocybin) from their Schedule I status.
The only way the patients’ physician, Dr. Aggarwal, could provide them with psychoactive treatment would be for him to register as a researcher.
After this reply, the patients and Dr.Aggarwal sued the DEA. The Court of Appeals heard testimonies and received amicus brief from various organizations, as well as bipartisan state attorneys general who supported their case.
After 10 months of arguments and legal briefings, the Court ultimately dismissed the dispute, stating that it did not have jurisdiction over the matter because the DEA’s position was not a final rule.
The plaintiffs’ attorney, Kathryn Tucker, therefore asked the DEA for a “final decision” on the case. Many months later, on June 28, the agency replied by reiterating its 2021 response: “DEA finds no basis for reconsideration of its February 12, 2021 letter because the legal and factual considerations remain unchanged,” an agency administrator commented.
Tucker has asked the DEA to confirm whether this last letter constitutes a final decision on their part. She told The Microdose that if they don’t have a reply from the DEA by July 20, they will take the June 28 letter as the agency’s final standpoint and return to court.
In the attorney’s words, “We will seek expedited review, because of the urgency presented by the inexorable progression of terminal illness faced by Dr. Aggarwal’s patients.”
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