Thursday, 23 March 2023

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Clarifying regulations could help industries grow

Clarifying regulations could help industries grow

This year, investors are watching for big spikes in biotech companies working with psychedelics, especially as the once-controversial compounds return to the spotlight touting mental health benefits — and uniting lawmakers at the United States Capitol across party lines. 

The category’s future could make big legal gains in 2023, but due to the American government’s built-in checks and balances, even a Congress in agreement can’t shape drug policy alone.

In May 2022, New Jersey Democratic Senator Cory Booker and Hawaii Democratic Senator Brian Schatz co-published a letter imploring the National Institutes of Health and the Food and Drug Administration (FDA) to study the therapeutic use of psychedelics. By the end of the summer, Republican Representatives Matt Gaetz of Florida and Dan Crenshaw of Texas had also committed their support to the study of psychedelics.

By 2012, the FDA had already created the “Breakthrough Therapy Designation” (BTD), enabling researchers to administer trials of otherwise illegal drugs suspected to offer unexplored medical benefits. MDMA received its first BTD designation in 2017 and psilocybin in 2018. Oregon now allows psychotherapists to treat patients with psilocybin.

As lawmakers on either side of the aisle argue about psychedelics on the federal level — using their power to earmark funds for research — the persistent, unlikely bipartisan union is inspiring increasingly bullish sentiments among psychedelics firms and their investors.

Psychedelics in Congress

Don’t chalk it up to the “Age of Aquarius,” though. Aside from the potential healing benefits, it is support for veterans that drives cooperation around these drugs.

In July 2022, Representative Alexandria Ocasio-Cortez offered an amendment to the 2023 National Defense Authorization Act (NDAA) that would require the Department of Defense to study psilocybin and MDMA, alongside cannabis, as alternatives for combat who have post-traumatic stress disorder, at least 6,000 of whom took their own lives in 2022 alone.

Ocasio-Cortez introducing the amendments before Congress. Source: C-SPAN

Navy veteran and House Representative Dan Crenshaw offered a nearly identical amendment to the NDAA, with his focus on the psychedelics ibogaine and 5-MeO-DMT instead. “They are, I would argue, kind of collaborative amendments in a way,” Ocasio-Cortez told Bloomberg, confirming her office had communicated with Crenshaw’s.

Crenshaw had previously voiced support for MDMA…

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