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.
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