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Senators File Revised Bill Seeking to Reschedule Breakthrough Psychedelic Therapies

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A group of bicameral and bipartisan lawmakers has filed a revised bill that would reschedule psychedelics as breakthrough therapies and promote psychedelic research and drug development. Filed by Senators Rand Paul and Cory Booker alongside Representatives Nance Mae and Madeleine Dean, the Breakthrough Therapies Act seeks to streamline the federal process of rescheduling “breakthrough therapies” such as MDMA and psilocybin that have exhibited significant medical potential.

Thanks to a surge in psychedelic research in recent years, scientists have discovered that psychedelics have the potential to treat mental health disorders such as major depressive syndrome, anxiety and post-traumatic stress disorder.

The FDA has already approved the use of ketamine-assisted therapy for certain mental ailments and regulators are poised to grant similar approval to psilocybin (magic mushrooms) and MDMA in the near future. If the Breakthrough Therapies Act is successful, it will create a procedure that could amend the federal Controlled Substances Act and declare Schedule I drugs such as psilocybin as breakthrough therapies via the FDA.

The legislation could also make a currently controlled drug eligible for a waiver under the federal Food, Drug, and Cosmetic Act (FDCA) or transfer it to a lower schedule to reduce barriers to research and drug development. Drugs that meet any of these criteria would be moved to schedule II, which currently comprises severely restricted drugs that have “accepted medical use.”

Booker said in a public statement that certain schedule I drugs, such as psilocybin and MDMA, could significantly contribute to improvements in the treatment of PTSD, addiction and depression. He also noted that the revised bill would get rid of unsavory rules and regulations that prevent or delay scientific research into “breakthrough mental health treatments.” Furthermore, Booker noted that the bill would ensure patients who are in urgent care for mental health treatments can access psychedelic-assisted therapies.

Paul, who is also a physician, said that he was proud to partner with Booker on the psychedelics measure as it would eliminate government barriers in psychedelic research and provide patients who need medical care with compassionate care. The bipartisan pair of lawmakers first filed the bill to reschedule psychedelic breakthrough therapies and eliminate research barriers last November. The legislation would allow researchers with existing DEA schedule I and II registrations to research schedule I drugs after sending a notice to the attorney general.

It would also allow several researchers at a single institution to research schedule I drugs under one registration rather than requiring every scientist in a schedule I drug study to apply for separate registration from the DEA.

This bill is likely to be of great interest to psychedelics startups such as Field Trip Health Ltd. (OTC: FTHWF) (TSX: FTHW) since any law passed in this regard would have a direct impact on the research they are conducting on these hallucinogenic substances.

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