Life Sciences Horizons Brochure 2025 - Flipbook - Page 117
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2025 Horizons Life Sciences and Health Care
Psychedelics: Has FDA missed its opportunity and allowed the states to
open the door?
The waiting game continues. Despite growing
momentum and demands for access to psychedelic
treatment, FDA has not approved psilocybin,
midomafetamine (MDMA), or any other novel
psychedelic for medical use; FDA has previously
approved ketamine and esketamine, which have some
hallucinogenic effects, for limited clinical use. Though
some of these Schedule I drugs have shown promising
results for treating mental health conditions such as
depression, PTSD, and anxiety, no treatment has yet to
meet the high evidentiary bar for FDA approval, as the
agency attempts to apply its existing framework for
these conditions which does not seem to be fit for
purpose in evaluating these novel treatments.
While FDA has been restrained by application of its drug approval
standards to these novel treatments, states have been pressing
ahead. In 2020, the Oregon Psilocybin Services Act permitted the
state to begin regulating the production of psilocybin products
and the administration of psilocybin therapy, despite the
substance’s status as a Schedule I substance under the federal
Controlled Substances Act (CSA). And, in 2023, the state licensed
its first “psilocybin service centers.” At these centers, patients (21+)
can consume state-regulated psilocybin products while being
monitored by licensed facilitators. State materials tout the
“benefits” of psilocybin including research suggesting the drug
may help with “depression, anxiety, trauma, and addiction” and
“increase spiritual well-being.”
This year, Colorado will begin to offer similar services, and is
allowing separate licenses for centers that store relatively small
amounts of psilocybin products (not more than 750 mg of
psilocin), ideal for current mental health or wellness practitioners
seeking to tack psilocybin services on to their existing practice.
Advocates for psychedelic therapy and patients seeking new
effective treatments for difficult to treat conditions continue to
request FDA-approved treatment options, and we expect the first
few psychedelic approvals to trickle in over the next few years.
Even so, it is unclear if FDA will be able to reel in this emerging
industry, which is currently operating under state initiatives and
permitting the use of non-FDA approved drugs that are not stifled
by prior authorizations, REMS programs, etc. — especially if more
states follow suit.
Lynn Mehler
Partner
Washington, D.C.
Eva Marie Schifini
Senior Associate
Los Angeles
