The FDA recently published draft guidance titled “Psychedelic Drugs: Considerations for Clinical Investigations, Draft Guidance for Industry.”

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This FDA's draft guidance seeks to shape the future of clinical investigations related to psychedelic drugs, which holds immense promise for breakthrough mental health treatments.

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While the draft provides foundational guidelines, it also presents potential constraints that may impact the broader mental health community and the ways in which these transformative treatments are administered.

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As the premier technology platform for breakthrough mental health treatment, Osmind has taken the initiative to submit detailed comments addressing the guidance. Our commitment as a Public Benefit Corporation is to ensure that the voice of the mental health community is heard, advocating for procedures that prioritize patient well-being and the innovative potential of psychedelic treatments.

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We urge you to join our efforts in shaping a future that upholds the best interests of patients and practitioners alike. The deadline to leave your comments is swiftly approaching at 11:59 PM ET on August 25th.

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Submitted electronically

To: Food and Drug Administration

RE: FDA-2023-D-1987 (Psychedelic Drugs: Considerations for Clinical Investigations, Draft Guidance for Industry)

From: Osmind, Inc

Date: August 22, 2023

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To Whom it May Concern:

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Osmind appreciates the opportunity to comment on the draft guidance entitled “Psychedelic Drugs: Considerations for Clinical Investigations, Draft Guidance for Industry.”

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Osmind is a Public Benefit Corporation that is the premier technology platform for breakthrough mental health treatment. The Osmind treatment platform is currently used by over 500 leading mental health practices to safely administer, monitor, and analyze the use of treatments for people living with moderate to severe mental health conditions — notably, we are the leading EHR for practices offering ketamine and SPRAVATO®.

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The core electronic health record technology is precisely developed for mental health treatment workflows, including journaling tools and outcomes tracking, and designed to support a strong therapeutic alliance, with telehealth enablement and assistance with insurance reimbursement, which is a significant access hurdle for millions of patients.

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In addition, Osmind translates patient experience into real-world evidence (RWE) with researchers, clinicians, and clinician-scientists to benefit the entire mental health community. This research is already helping to set new standards for mental health interventions, via our publications and scientific collaborations.

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The views and opinions expressed in this letter are those of Osmind and do not necessarily reflect the views and opinions of all the independent practitioners and patients that use the Osmind platform.

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As the leading technology platform for practitioners of psychedelic medicine, we are well positioned to provide a number of recommendations regarding the proposed guidance:

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1) Modify the criteria for lead monitors and assistant monitors to be more inclusive of a wider range of practitioners.

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The field of psychedelic medicine is very collaborative, and there are a wide range of indications being explored for these drugs across a variety of care delivery settings. The field encompasses disciplines such as psychiatry, psychology, pain management, palliative care, oncology, neurology, and anesthesia. We have many different types of professionals using our platform to safely deliver interventions. While the current guidance is aimed at clinical research, it could set the precedent for eventual clinical standards and insurance coverage. Therefore, we recommend the following modifications:

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• Lead Monitors: “Psychiatric Nurse Practitioners and other Advanced Practice Registered Nurses.”

• Assistant Monitors: “An assistant monitor with a bachelor’s degree or a licensed registered nurse. Assistant monitors should have at least 1 year of clinical experience in a licensed healthcare setting.”

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2) Provide additional guidance on complementary trial designs to adequate and well-controlled (AWC) studies that involve real-world data.

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As highlighted in the guidance, there are fundamental challenges with a placebo control group in the context of randomized controlled trials for psychedelics. The functional unblinding for both the subject and the investigator can introduce bias into the study. More broadly, there are ethical considerations of randomizing a person with chronic, severe mental illness to receive placebo. Given these unique considerations for psychedelic drugs, we request that the FDA comment on alternative trial designs in future versions of this guidance:

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• Externally controlled trial design whereby a historical control or concurrent control reflecting standard of care is utilized from real-world data (RWD) or prior investigator-initiated trials (FDA-2022-D-2983-0002)

• Open-label extensions to RCT whereby patients in the control group can receive the psychedelic drug and contribute to the long-term safety and efficacy data

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3) Work collaboratively with health technology organizations to accelerate the platform and process development needed for the collection of post-marketing data and RWE.

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We are enthusiastic about the FDA’s efforts to incorporate RWE to support regulatory decision-making (FDA-2020-D-2307), especially in the post-marketing phase of drug approvals.

Areas of potential collaboration with health technology organizations that are relevant to psychedelic medicine include:

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• Risk evaluation and mitigation strategies (REMS) programs: Just as SPRAVATO® has a robust REMS program, we anticipate the psychedelic drugs in the pipeline will as well. At Osmind, we are the only EHR that has an integration with the SPRAVATO® REMS program. This integration reduces friction for clinicians which increases the likelihood that they will adopt new interventions with a high regulatory burden.

• Data quality requirements for RWE: By working collaboratively with the FDA and study sponsors, health technology organizations in the RWE space can ensure that data needed for post-marketing efforts and other observational studies is collected in a feasible way that adheres to all regulatory requirements.

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Osmind is grateful for the opportunity to provide comments on this proposed guidance. Given our role as an electronic health record and research platform, the above recommendations are focused on areas we believe the wide range of practices using our system would find reasonable, and are areas where our technological and clinical expertise could come to bear.

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If you have any questions please feel free to contact us.

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Respectfully,

Carlene MacMillan, MD, Chief Medical Officer

L. Alison McInnes, MD, MS, VP Scientific Affairs

Lucia Huang, Co-founder and CEO

Jimmy Qian, Co-founder and President, and the team at Osmind