IBOGAINE Act

Increased Access to Life-Saving Treatments: The bill seeks to accelerate the development of and access to psychedelic drugs that could save lives and reverse the crisis of serious mental illness (Introduction).

Incentivizing Breakthrough Medical Products: The National Health Priority Voucher Pilot Program awards vouchers to sponsors of products that address public health crises, unmet medical needs, or improve healthcare affordability (Section 4).

Enhanced Physician Authority under Right to Try: The bill amends the Federal right to try law to include provisions regarding the unauthorized use, possession, and distribution of eligible investigational drugs (Section 5).

Streamlined Medical Research and Quotas: The bill requires the Attorney General to revise production quotas for controlled substances within specific timeframes if a drug is approved or designated as a breakthrough therapy (Section 7).

Support for Research via Partnerships: The Secretary of Health and Human Services may partner with States, territories, and Indian Tribes to advance research on psychedelic drugs (Section 8).

Improved Veteran Care and Training: The Department of Veterans Affairs is tasked with developing a workforce implementation-readiness plan to ensure clinicians are trained for safe and effective implementation of emerging therapies (Section 12).

Potential Costs to Sponsors: The Secretary may establish a user fee program that requires sponsors of a national health priority product application to pay a fee (Section 4, subsection c).

Strict Requirements for Physicians: Physicians wishing to administer Schedule I drugs must undergo a specific registration process, which includes providing evidence of compliance, documentation from manufacturers, and descriptions of storage sites (Section 6).

Regulatory Oversight of Possession: Physicians treating patients with Schedule I drugs are limited to possessing only the specific amounts of the drug identified in their application or supplemental notification (Section 6).