On behalf of Reason for Hope and the Veteran Mental Health Leadership Coalition, we write to voice our support for S.B. 229, a bill establishing an Advisory Council on Breakthrough Therapies for Veteran Suicide Prevention. We commend you for initiating this important Bill. Thank you Our nation’s military Veterans have a clear and urgent need for more effective mental health treatments. Currently, we lose around 44 Veterans every day to suicide, overdose, or other forms of self-injury. Combat Veterans are not only more likely to have suicidal ideation, often associated with post-traumatic stress disorder (PTSD) and depression, but they are more likely to act on a suicidal plan. Further, Veterans with comorbid major depressive disorder and PTSD are more than twice as likely as those with only PTSD to have attempted suicide. Fortunately, in recent years, studies from premier academic institutions across the globe have found that MDMA (an entactogen) and psilocybin (a classic psychedelic) – used as an adjunct to psychotherapy – offer rapid and robust improvement in treating these serious psychiatric conditions. Indeed, due to the incredible results achieved in well-controlled clinical trials, the U.S. Food and Drug Administration (FDA) granted a Breakthrough Therapy Designation to MDMA for the treatment of PTSD (2017) and to two different psilocybin therapies, one for treatment-resistant depression in 2018, and a second for major depressive disorder in 2019. The Breakthrough Therapy designation is a process designed to expedite the development and review of drugs where preliminary clinical evidence has indicated that the drug may demonstrate substantial improvement over available therapies. The FDA could approve MDMA as a prescription medication for PTSD by later this year, with potential patient access to MDMA-assisted therapy by early 2025. FDA approval of psilocybin for treatment-resistant depression and/or major depressive disorder is expected to follow within the next couple years. However, despite their immense promise for treating difficult mental health conditions and preventing Veteran suicides, these powerful and time intensive treatments do not fit neatly within our current system of mental healthcare. Specifically, clinical trials for these treatments most often utilize a care model involving a continuum of support during preparation sessions, medication administration session(s) lasting potentially 6-8 hours each, and integration therapy sessions (a process generally referred to as “psychedelic-assisted therapy”). In practice, this will likely require an interdisciplinary treatment approach with specialized training for prescribers and session facilitators, and vastly different cost, insurance coverage, and infrastructure considerations. We expect FDA approval will come with a Risk Evaluation and Mitigation Strategy (REMS) requiring medication administration sessions be offered in-clinic with some form of psychological support. Yet, it is ultimately the state’s responsibility to regulate the practice of medicine and therapy. The Advisory Council established through this bill can play a vital role in guiding the state on important policy considerations to safely offer treatment to Virginia’s veterans. Thank you for your consideration.

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