Dave HodesEarlier this month, the U.S. government took a significant step toward legitimizing psychedelics as a therapeutic treatment by announcing the formation of an interagency task force around the issue.
“This is progress!” tweeted Florian Brand, co-founder and CEO of Atai Life Sciences, about the task force, which would address issues associated with the approval and rollout of medical psychedelics to treat mental health disorders by the Substance Abuse and Mental Health Service Administration (SAMHSA) and the Office of the Assistant Secretary for Health.
Today, we applaud the leadership of the @HHS and @SAMHSA.
This week, our CEO @Flobrand sent a letter to @SAMHSA_Leader to express our support of her vision of a public-private federal task force to help guide the rollout of therapeutic #psychedelics.
This is progress! pic.twitter.com/pS4TxvyRdZ
— atai Life Sciences (@atai_life) August 11, 2022
The announcement was a year in the making, with the concept first proposed in a series of briefings last fall by Reason for Hope, a veteran mental health leadership coalition, to the Health and Human Services (HHS) and SAMHSA leadership.
The Biden administration then included this as part of its goals to address the nation’s mental health crisis.
As 2021 ended, Reason for Hope had also briefed members of Congress and leadership within the Department of Veteran Affairs, the Department of Defense, and the United States Patent and Trademark Office on the complexities of interrelated issues driving the need for the task force and a public-private partnership working with stakeholders.
The intended result of the interagency strategic task force is to publish national guidelines in the federal register pertaining to issues such as provider training, credentialing, state licensure, dispensing, monitoring and instituting good standards of safe and ethical practice. States will receive block grant funding and support from SAMHSA to implement or tailor the guidelines to meet their individual needs.
There had been a steady stream of requests for the formation of the interagency federal task force this year after the Reason for Hope briefings.
In February, five members of Congress (Madeline Dean (PA), Earl Blumenauer (OR), Brian Fitzpatrick PA), Dean Phillips (MN) and Michael Waltz (FL)) sent a letter to Xavier Becerra, secretary of the Department of Health and Human Services, requesting the establishment of an interagency task force on the proper use and deployment of psychedelic medicine and therapy.
The proposed group would be located in the Office of the Assistant Secretary of Health where it can “ideally leverage the convening authority of the Office of Management and Budget, and ensure all relevant federal agencies work in partnership with public and private sector stakeholders, including state agencies, to draft necessary regulations and guidelines,” the congresspeople wrote. “This prudent measure will help to ensure our nation has a framework for the responsible, accountable, safe, and ethical deployment of psychedelic therapies for mental health disorders when the FDA approves their use.”
The first sign that the interagency task force may actually be formed came in a letter written in July by the co-founder and CEO of the Reason for Hope coalition, a three-star Marine lieutenant general, Martin Steele, who added task force information in his letter of support of the Right to Try Clarification Act introduced by senators Rand Paul (R-KY) and Cory Booker (D-NJ).
Steele wrote that his coalition has been leading an ambitious initiative to streamline the regulatory infrastructure for MDMA- and psilocybin-assisted therapy through advocating for the establishment of the interagency task force in the Department of Health and Human Services, which is meant to issue guidelines that assist states in addressing the complex clinical, regulatory and public policy issues necessary for the real-world deployment of these treatments.
More details were posted on the Reason for Hope website: “We are proud to share that the Substance Abuse and Mental Health Service Administration, on behalf of Secretary Becerra, recently responded in agreement and indicated plans to move forward with the suggested Federal Task Force.”
Steele added that his group hopes the regulatory initiatives of the task force will be done quickly. The coalition is currently helping to support the task force and seeking dedicated federal funding for state expanded access pilot programs.
The actual date of the establishment of the task force is still to be determined, though indications are that it will come together around the same time as FDA regulatory approval of MDMA and psilocybin.
