As a wave of drug reform sweeps across America, psychedelics have emerged as a potential alternative to traditional psychiatric remedies. Initial studies have shown that psychedelics can be quite effective at alleviating the symptoms of mental health conditions such as depression and post-traumatic stress disorder without the usual side effects.
When paired with therapy, psychedelic treatments can deliver profound and long-term benefits after just a single dose. Consequently, several lawmakers have been keen on loosening America’s otherwise strict psychedelic laws to allow for further research and the development of psychedelic-assisted therapies.
Senators Rand Paul and Cory Booker recently filed legislation that would compel the U.S. Drug Enforcement Agency (DEA) to reschedule novel psychedelic therapies from Schedule 1 to Schedule II.
Hallucinogenic drugs such as MDMA and psilocybin have been found to deliver incredibly encouraging results in studies and clinical trials, but their strict scheduling makes it incredibly difficult for researchers to study such drugs extensively.
The Breakthrough Therapies Act would amend the federal Controlled Substances Act in several ways to expand psychedelic research and make it easier for researchers to study hallucinogenic drugs like psilocybin. It would also create a framework that the FDA could use to deem psychedelics that are currently classified as Schedule I drugs as breakthrough therapies and transfer them to a lower schedule. Psychedelics that qualify for a waiver under the federal Food, Drug, and Cosmetic Act could also qualify for transfer to a lower schedule.
These amendments would make it a lot easier for researchers to study psychedelic drugs and develop safe and effective psychedelic treatments for the general public.
As per the Breakthrough Therapies Act, the administrative process for rescheduling a psychedelic drug would be automatically triggered as soon as the drug qualified for an FDCA waiver or is designated as a breakthrough therapy.
Coincidentally, the two senators filed their legislation on the same day that bipartisan House lawmakers announced they had formed the first-ever congressional caucus to discuss the developing field of psychedelic therapy. The Congressional Psychedelics Advancing Clinical Treatments (PACT) Caucus will be chaired by Representatives Jack Bergman and Lou Correa.
If the new senate legislation is advanced, research into psychedelic drugs would become much smoother because researchers will not have to jump through extensive and burdensome hoops before they receive approval. Furthermore, several scientists in a single institution would be able to conduct their research under a single registration rather than requiring each scientist to receive separate registration from the DEA.
In a press release, Booker noted that his legislation would reduce burdensome rules and regulations which held back or directly prevented patients and researchers from accessing psychedelics. If passed, this legislation could have a positive bearing on the work being done by psychedelics companies such as Field Trip Health Ltd. (OTC: FTHWF) (TSX: FTHW) in their bids to come up with therapeutic formulations that are approved by the FDA.
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