Health Subcommittee, Veterans' Affairs Committee, Judiciary Committee, Energy and Commerce Committee
Introduced
In Committee
On Floor
Passed Chamber
Enacted
This legislation, titled the Initiating Biomedical Outcomes to Garner Advancements into Innovative Neuroplastogen Efficacy Act or the IBOGAINE Act , seeks to accelerate the development and access to psychedelic drugs for treating serious mental illnesses in the United States. It specifically defines "ibogaine" to include the Tabernanthe iboga plant and similar compounds that act on neuroplasticity, opioid receptors, or serotonergic pathways to interrupt addiction cycles and restore neurological function. A key provision establishes a National Health Priority Voucher Pilot Program , allowing the FDA to award non-transferable vouchers for priority review of a single human drug application. These vouchers are granted to sponsors of products addressing public health crises, breakthrough therapies, large unmet medical needs, or those enhancing domestic drug supply chain resilience and affordability. The program includes user fees and is designed to supplement existing incentive programs, with a termination date of September 30, 2029. The bill amends the Federal Right to Try law to explicitly include Schedule I investigational drugs, overriding Controlled Substances Act prohibitions for unauthorized use in this context. It mandates a special registration process for physicians to directly administer Schedule I eligible investigational drugs to eligible patients, with specific application requirements and a 45-day approval timeline. Furthermore, it revises DEA quota requirements for controlled substances, requiring adjustments within 90 days for Schedule I and 60 days for Schedule II drugs upon triggering events like FDA approval, breakthrough therapy designation, or entry into Phase 3 clinical trials. The legislation promotes Federal-State collaboration through the Department of Health and Human Services to advance research and development of psychedelic drugs, including ibogaine. It also mandates interagency collaboration with the private sector to increase clinical trial participation and data sharing, prioritizing breakthrough therapies. Crucially, it requires the Attorney General to initiate and complete rescheduling proceedings for Schedule I drugs upon successful completion of Phase 3 clinical trials, with a specific directive to determine whether to transfer ibogaine and its compounds from Schedule I to Schedule II within 60 days of enactment. Within the Department of Veterans Affairs (VA), the bill mandates the designation of a senior official for emerging therapeutic interventions to oversee related policies and programs. The VA is also required to submit biannual reports on its activities concerning emerging therapeutic interventions, including psychedelic-assisted therapies, detailing research, clinical outcomes, veteran enrollment, and interagency coordination. Additionally, the VA must develop a workforce implementation-readiness plan for these therapies, including assessments, standardized training frameworks, and credentialing standards to ensure safe and effective delivery. Finally, the Secretary of Veterans Affairs, in collaboration with the FDA Commissioner and DEA Administrator, must provide a report to Congress within 180 days on the implementation of Executive Order 14401, which focuses on accelerating medical treatments for serious mental illness.
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Timeline
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, and Veterans' Affairs, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, and Veterans' Affairs, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
This legislation, titled the Initiating Biomedical Outcomes to Garner Advancements into Innovative Neuroplastogen Efficacy Act or the IBOGAINE Act , seeks to accelerate the development and access to psychedelic drugs for treating serious mental illnesses in the United States. It specifically defines "ibogaine" to include the Tabernanthe iboga plant and similar compounds that act on neuroplasticity, opioid receptors, or serotonergic pathways to interrupt addiction cycles and restore neurological function. A key provision establishes a National Health Priority Voucher Pilot Program , allowing the FDA to award non-transferable vouchers for priority review of a single human drug application. These vouchers are granted to sponsors of products addressing public health crises, breakthrough therapies, large unmet medical needs, or those enhancing domestic drug supply chain resilience and affordability. The program includes user fees and is designed to supplement existing incentive programs, with a termination date of September 30, 2029. The bill amends the Federal Right to Try law to explicitly include Schedule I investigational drugs, overriding Controlled Substances Act prohibitions for unauthorized use in this context. It mandates a special registration process for physicians to directly administer Schedule I eligible investigational drugs to eligible patients, with specific application requirements and a 45-day approval timeline. Furthermore, it revises DEA quota requirements for controlled substances, requiring adjustments within 90 days for Schedule I and 60 days for Schedule II drugs upon triggering events like FDA approval, breakthrough therapy designation, or entry into Phase 3 clinical trials. The legislation promotes Federal-State collaboration through the Department of Health and Human Services to advance research and development of psychedelic drugs, including ibogaine. It also mandates interagency collaboration with the private sector to increase clinical trial participation and data sharing, prioritizing breakthrough therapies. Crucially, it requires the Attorney General to initiate and complete rescheduling proceedings for Schedule I drugs upon successful completion of Phase 3 clinical trials, with a specific directive to determine whether to transfer ibogaine and its compounds from Schedule I to Schedule II within 60 days of enactment. Within the Department of Veterans Affairs (VA), the bill mandates the designation of a senior official for emerging therapeutic interventions to oversee related policies and programs. The VA is also required to submit biannual reports on its activities concerning emerging therapeutic interventions, including psychedelic-assisted therapies, detailing research, clinical outcomes, veteran enrollment, and interagency coordination. Additionally, the VA must develop a workforce implementation-readiness plan for these therapies, including assessments, standardized training frameworks, and credentialing standards to ensure safe and effective delivery. Finally, the Secretary of Veterans Affairs, in collaboration with the FDA Commissioner and DEA Administrator, must provide a report to Congress within 180 days on the implementation of Executive Order 14401, which focuses on accelerating medical treatments for serious mental illness.
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Timeline
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, and Veterans' Affairs, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, and Veterans' Affairs, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.