The U.S. Drug Enforcement Administration has urged a federal appeals court to deny a doctor’s attempt to administer psilocybin to dying patients under so-called Right to Try legislation, arguing that such laws do not provide for exemptions to the federal Controlled Substances Act (CSA).
Dr. Sunil Aggarwal, co-founder of the Advanced Integrative Medical Science Institute, a psychedelics research and treatment clinic based in Seattle, has sued the DEA several times for authorization to use psilocybin as a treatment for depression and anxiety by terminally ill patients. Aggarwal’s legal actions are based on federal and state Right to Try laws, which permit patients with terminal illnesses to use investigational drugs for therapeutic purposes before they are approved for general use by the Food and Drug Administration (FDA).
Psilocybin, the compound primarily responsible for the psychedelic effects of magic mushrooms, has been shown through clinical research to have great potential as a treatment for serious mental health conditions including depression, anxiety, post-traumatic stress disorder and substance misuse disorders. The compound has been designated as a “breakthrough therapy” by the FDA but remains a Schedule I drug under the CSA, a classification reserved for drugs with no medical value.
The state of Washington approved a Right to Try bill in 2017, the same year former President Donald Trump signed the federal Right to Try Act into law. Aggarwal argues in his legal action that the legislation gives him the right to administer psilocybin to his patients with terminal illnesses.
The DEA, however, has rejected Aggarwal’s attempts to gain the authority to administer psilocybin to his patients. In its rationale for rejecting a 2022 petition seeking such authority, the DEA argued that treating terminally ill patients with psychedelics would be inconsistent with maintaining public health and safety. Aggarwal also claims the DEA wants him to register as a researcher to administer psilocybin, which is not a requirement of the federal Right to Try Act.
Aggarwal appealed the DEA decision to the U.S. Ninth Circuit Court of Appeal, arguing that it was arbitrary and inconsistent with public health interests and established legal precedent. In February, he argued that the DEA must explain how its decision is consistent with the CSA and its own policies, noting that the agency has issued waivers for the therapeutic use of other Schedule I drugs, including the use of medical cannabis by children.
In a filing to the court last week, the DEA said that the Right to Try Act amends the Federal Food, Drug, and Cosmetic Act but does not affect the CSA. The agency also said doctors who wish to administer controlled substances must abide by both statutes.
“The CSA and the FDCA (which the Right to Try Act amends) are separate regulatory schemes with separate requirements and restrictions,” the DEA wrote, as quoted by Green Market Report. “Nothing in the Right to Try Act changes that.”
The DEA also argued that the court should reject Aggarwal’s claims because he has not provided sufficient evidence to support them. The law enforcement agency also said it could not adequately evaluate his plan to administer psilocybin because he did not give enough information to justify the waiver he was requesting.
Shawn Hauser, a partner at the cannabis and psychedelics law firm Vicente LLP, slammed the DEA’s position, saying the agency “continues to overtly misinterpret the law using unlawful delay tactics to deny terminally ill patients access to life-saving medicines that federal law affords them access to.”
“Federal Right to Try laws were designed to allow eligible, terminally ill patients who qualify to use investigational new drugs that have undergone clinical trials (such as psilocybin), even if they are Schedule I substances,” Hauser wrote in an email to High Times.
“The law includes a clear exception to the FDCA’s safety/efficacy requirements that allow the use of unapproved, investigational drugs, such as psilocybin, that have completed successful FDA trials, by terminally ill patients,” she added. “This seems to be another excuse and obstruction by the DEA to deny patients access to a life-saving treatment that studies clearly demonstrate can be used safely as medicine.” (Full Story)