HI HB1340

Requires the Director of Health to establish a temporary breakthrough therapy designation advisory council within three months of the U.S. Food and Drug Administration approving a designated breakthrough therapy for mental health or substance abuse treatment.

Council membership includes the executive director of the office of wellness and resilience (chairperson), attorney general, director of law enforcement, health committee chairpersons from both chambers of the legislature, licensed physicians or advanced practice registered nurses, and other community or stakeholder representatives as recommended.

Members serve without compensation but may be reimbursed for necessary expenses including travel costs.

Council duties include examining federal and state laws, regulations, and practices; reviewing clinical and scientific studies on treatment safety and efficacy; examining professional requirements and guidelines for prescribers; and submitting findings and recommendations to the legislature within one year of convening.

Advisory council terminates when the breakthrough therapy designation is withdrawn or when the treatment receives final approval from the U.S. Food and Drug Administration.