Mar 17, 2022
OVERVIEW:
Jason A. Duprat, Entrepreneur, Healthcare Practitioner, and Host of the Healthcare Entrepreneur Academy podcast, talks with Hilary Bricken, Partner and Attorney, and Ethan Minkin, Attorney with Harris Bricken, an international law firm. Hilary and Ethan discuss the legalities of psychedelics and ketamine. They also highlight the value of entrepreneurship for moving psychedelic efficacy and advocacy forward.
EPISODE HIGHLIGHTS
- Ethan started his law career in 1999 with an interest in healthcare regulatory work, litigation, and transaction. He joined Harris Bricken 1.5 years ago with a focus on psychedelics.
- Hilary is a partner at Harris Bricken and her expertise is in controlled substances regulation, legal reform, and policy reform.
- There’s increasing discomfort from entrepreneurs surrounding the overregulation of psychedelics and ketamine.
- Work is being done in Oregon that will be the best test case. If the state beats the federal level, opportunities will open up. Right now, there’s no reimbursement for ketamine since it’s off-label.
- Hilary and Ethan are proponents of off-label ketamine because it’s innovative, guarantees an income stream, and is advantageous over its traditional use.
- Controlled substances can be prescribed through telemedicine under certain circumstances.
- Ketamine should be part of a treatment plan and not a one-stop option. Therapists and psychologists should be involved in a patient’s care plan.
- In the last three years, many clinics have added mental health therapy as part of their provider services.
- Combining ketamine and concierge care is possible as long as it's compliant with laws and regulations.
- False advertising is penalized under consumer protection laws, so credible studies must be cited in the literature.
- The quality of literature should be statistically significant - the gold standard - and include high-impact journals like JAMA (Journal of the American Medical Association).
3 KEY POINTS
- Psychedelics and ketamine have a potentially broader reach if regulations are relaxed.
- The path of entrepreneurship is critical for building a full suite of services for psychedelics.
- Protection of patients and consumers always comes first.
TWEETABLE QUOTES
“A first-mover advantage is a thing, but if it’s ketamine, you’re dealing with a very antiquated, heavily regulated, extremely consequential system, so proceed accordingly.” – Hilary Bricken
“If you’re treating someone for a mental health issue, make sure they’re also seeing a therapist or a psychologist, and not just getting ketamine and being sent on their way.” - Ethan Minkin
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