As part of the conversation (see Part 1 and Part 2) on the potential of psychedelic-assisted therapies (PAT) as a lawful and viable treatment for the veteran community, co-founders of national organization Reason for Hope, Brett Waters and Ret. Marine LtGen Martin Steele, provided further details about the nonprofit’s efforts promoting drug reform and educating officials and stakeholders on the matter.
Group Efforts & Comments To FDA
Reason for Hope’s work includes establishing pilot programs connecting research and access to treatment for those most in need, while a sister organization, the Veteran Mental Health Leadership Coalition, specifically advocates for increased research and safe and affordable access to PAT for veterans and their families.
Both have a “pretty cool” relationship with other actors in the space and have partnered with non-veteran-specific organizations to build out a multidisciplinary public health-focused coalition.
Because, as Waters says, “there are many, very complex legal and regulatory issues at play here.”
That’s why they advocated with the Biden administration, HHS and Congress on the need for clarity from the federal government to convene an interagency task force.
That is, a public-private partnership with stakeholders to clarify the path forward, considering states are actively advancing reform measures concerning psychedelics.
Confusion pertains to several issues like medical and therapeutic use and required training and licensing. Because as much as they traditionally concern state law, it is the FDA that regulates drugs and oversees approval of new medicines while the DEA oversees controlled substances and enforcement of the many other regulatory entities involved.
Concerns include potential criminal enforcement for states advancing measures, depending on the administration in power as well as the fact that no healthcare insurance will cover non-medical programs using FDA-unapproved products.
Toward convening this proposed larger body for clarity on these issues, the Coalition, Reason for Hope and BrainFutures led a joint comments submission to the FDA’s draft guidance on ways to prevent non-medical use and diversion yet updating it to effectively enable research.
Plausible Federal Plays
Waters says that regardless of what legislation Congress passes -although there’s hope around the Breakthrough Therapies Act’s passing, “maybe through an end-of-year omnibus bill,”- the coalition is “absolutely” seeing policy reform from the Biden administration.
“Just generally speaking, there’s been significant movement from SAMHSA, the HHS, the FDA, the NIH setting up research groups, the VA starting to move forward with policy planning. There's a lot of positive momentum right now,” he said.
Waters also believes a rescheduling and policy change from the DEA is possible. That would allow for the allocation of the much-needed federal funding toward research, without the need to pass the BTA bill.
Still, he thinks there’s a possibility Congress eventually includes language “actually requiring funding for at least therapies within the VA.”
Reason for Hope’s CEO and the Coalition’s president Steele says the group is in this for the long haul.
“It's been cooperative and collaborative with other organizations and wrench work with the government officials that we're working with for the bill’s design. And we intend to keep it that way as we move forward, because this has the major potential to be able to change the whole culture in regards to mental health treatment, and we're going to stay with it to help make that happen,” Steele shared.
Photo by Tim Mossholder on Unsplash
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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