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Microdose of psilocybin
A microdose of psylocibin.
Despite their opposition to it, the Drug Enforcement Administration (DEA) must comply with federal and state “Right to Try” laws. The offensive of pro-Right to Try activists is twofold: While lawmakers introduce legislation to solidify the legal standing of the laws in question, the DEA is being sued due to its refusal to allow doctors to treat terminally ill patients with drugs that aren’t currently approved for medical use.
What Is the Right to Try?
The 2018 Right to Try Act, which was originally sponsored in the Senate by Wisconsin Sen. Ron Johnson, allows end-of-life patients who tried all approved treatment options to access unapproved treatments. Because of the extremely slow nature of the drug approval process, the right to try is meant to allow patients with no other hope for treatment to take a risk with a doctor’s approval. The vagueness with which the Food and Drug Administration (FDA) defines those “unapproved treatments” is the source of the conflict between activists, lawmakers and the DEA.
On one hand, many lawmakers, physicians and patients believe that the Right to Try Act already covers what can be described as recreational drugs, including marijuana and MDMA. On the other hand, the DEA believes that the 2018 law is much less broad. In fact, the DEA announced that the right to try doesn’t allow exceptions to the Controlled Substances Act and does not guarantee access to Schedule I drugs in particular. Schedule I is the most heavily criminalized category, and marijuana is wrongly categorized as a Schedule I drug.
Drug reform champion Rep. Earl Blumenauer wrote a letter to the DEA in January 2022 denouncing the agency’s refusal to cooperate regarding psilocybin use for patients with life-threatening illnesses. “Research demonstrates that psilocybin provides immediate, substantial and sustained relief from debilitating anxiety and depression in individuals with terminal illnesses. We strongly believe that our constituents suffering such illnesses should have access to this investigational drug should they decide to pursue such a course of treatment,” Rep. Blumenauer wrote. “Psilocybin qualifies as an investigational drug under the terms outlined in applicable state and federal statutes. Notwithstanding, suffering dying individuals seeking treatment with psilocybin are being prohibited from receiving such a treatment because of the DEA’s refusal to accommodate the Right to Try.”
The Fight for This Right
After the DEA’s initial refusal to allow a cancer patient to access psilocybin therapy, the agency was sued but the lawsuit was dismissed in February 2022 on procedural grounds. Since then, the DEA has been digging their heels in the ground until the plaintiffs’ lawyers submitted a new lawsuit in the U.S. Ninth Circuit Court of Appeals on Friday, July 22.
The reason why the first lawsuit was dismissed is due to the DEA’s claim that the agency has no authority to address Right to Try policies. The court, at the time, ruled that the DEA’s choice of sitting on their metaphorical hands did not constitute a definite “no” to applying the law. Activists have spent the next few months demanding that the DEA clarify whether they definitely refuse to comply with the Right to Try Act. Plaintiffs consider that months of deliberate mutism on the topic is worth a confession from the DEA.
The DEA “is attempting to use the Controlled Substances Act [CSA] as a cudgel to thwart state medical practice, to the detriment of dying patients,” the lawsuit alleges. The filing openly accuses the DEA’s behavior of being “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”
Alongside the judicial push against the DEA is a legislative one. Spearheaded by Sens. Cory Booker (D) and Rand Paul (R), as well as Reps. Blumenauer (D) and Nancy Mace (R), bipartisan bills were introduced to explicitly clarify that Schedule I drugs are included under the Right to Try Act of 2018. “The Right to Try Clarification Act would remove any obstacle presented by the Controlled Substances Act with respect to Schedule I substances when they are used by doctors and patients in accordance with the federal Right to Try law,” says Sen. Booker’s website.
“In recent years, two substances currently classified as Schedule I drugs—MDMA and psilocybin—have shown exceptional promise in treating a variety of mental health conditions, including suicidal depression, anxiety, and PTSD. In Phase 1 and 2 clinical trials, these drugs have been shown to be safe and effective—so effective that FDA has designated them ‘breakthrough therapies,’ meaning that they demonstrate substantial improvement over any currently available therapies. [...] Unfortunately, many eligible patients who urgently need care do not currently have access to these promising therapies. This legislation will put the patient first and help ensure access to life-changing and life-saving drugs.”
