Freedom to Heal Act

The Freedom to Heal Act “creates a narrowly tailored DEA registration process exclusively for physicians to treat Right to Try eligible patients in clinical settings with qualifying Schedule I investigational therapies — such as MDMA and psilocybin – without changing the underlying RTT law.” https://lnkd.in/gAmyJWfU

It should be noted that DEA, all along, has had the authority to create such a registration. In the litigation challenging the DEA’s obstruction of operation of the RTT, Aggarwal v DEA, Plaintiffs pointed this out, and yet the DEA took no action. Enactment of the FTHA would compel this action. It is one way to open access to those who desperately need it, including terminally ill patients with debilitating anxiety and depression. The pending petition to reschedule psilocybin could achieve the same result, because once moved off of schedule I DEA would lose its ability to thwart access. The petition, filed in February 2022, was initially denied by DEA, prompting another lawsuit which resulted in remand to DEA for proper handling of the petition. In August of 2025 DEA finally transmitted the petition to HHS for medical and scientific review. If, as anticipated, the review is favorable and rescheduling recommended, a public comment period will open and all stakeholders will be able submit comments.

The full petition (and additional materials in support of the petition) can be viewed at the link below. It proposes movement to schedule II and provides a summary of the evidence supporting rescheduling. A broad array of organizations, clinicians, and researchers, support rescheduling and participated as “Friends of the Court” in a lawsuit related to the handling of this petition. The Veterans Mental Health Leadership Coalition’s brief can be reviewed at the link below.