Will the Dying Finally Have the Right to Try Psilocybin?

After years of DEA stonewalling, the tides may be shifting…

Right to Try laws were created to allow those with a life-threatening condition to access experimental drugs before they are approved by the FDA. Among the qualifying conditions, the drug needs to have passed Phase I trials demonstrating its preliminary safety and efficacy. It also has to be prescribed by the patient’s physician.

For treating anxiety and depression in the terminally ill, psilocybin – the psychoactive compound in “magic mushrooms” – has repeatedly demonstrated better outcomes and fewer side effects than conventional treatments.

And yet, as Seattle palliative care physician, Sunil Aggarwal discovered when he wanted to offer psilocybin to his cancer patients, with psychedelics, their right to try isn’t so straightforward.

In 2022, the Drug Enforcement Administration blocked Aggarwal’s request, citing psilocybin’s status as a Schedule 1 controlled substance. As a reminder, drugs classified under Schedule 1 are considered highly dangerous, with great potential for abuse and no medical value.

May 2022, Demonstrating at DEA Headquarters

With a compelling body of evidence to the contrary, in 2022, Aggarwal appealed to the DEA and the Department of Health and Human Services to reschedule psilocybin.

Initially, the DEA simply denied the request. But over the last three years, the case has gone back and forth between Aggarwal, the DEA and the courts.

Finally, this August, the DEA forwarded a petition asking HHS to evaluate the medical and scientific evidence for rescheduling psilocybin from Schedule I to Schedule II. ¹

This is a big deal.

The fact that HHS is now headed by RFK Jr., a proponent of psychedelic therapy, has sparked optimism and speculation in psychedelic circles.

Perhaps Aggarwal’s determination that offering relief to the dying is a professional and humanitarian imperative will finally help move the first classic psychedelic out of prohibition exile and into the mainstream.

If that happens, it will have been a long time coming.

Artwork by Lauren Meyer/Painter Dancer

1. Not only would Schedule II status open access to patients through the Right to Try, but it would also ease many of the onerous restrictions on researchers working with a Schedule I controlled substance.