STAND. COM. REP. NO. 1744
President of the Senate
State of Hawaii
The purpose and intent of this measure is to authorize the Director of Health to establish a Temporary Breakthrough Therapy Designation Advisory Council within three months of certain breakthrough therapy designation approvals by the United States Food and Drug Administration.
Your Committee received written comments in support of this measure from the Office of Wellness and Resilience in the Office of the Governor, Department of Health, Hawaii Psychological Association, Beyond Mental Health, Clarity Project, Honolulu Psychotherapy, and numerous individuals.
Your Committee finds that the advisory council required by this measure will help prepare the State for future treatments and technologies that have applications in behavioral health and are expected to receive full approval by the United States Food and Drug Administration in the next four to six years.
Your Committee has amended this measure by:
(1) Requiring, rather than authorizing, the Director of Health to establish a Temporary Breakthrough Therapy Designation Advisory Council upon the United States Food and Drug Administration's approval of certain breakthrough therapy designations;
(2) Clarifying that representatives from private entities should be invited to serve as members of the advisory council; and
(3) Making technical nonsubstantive amendments for purposes of clarity, consistency, and style.
As affirmed by the record of votes of the members of your Committee on Ways and Means that is attached to this report, your Committee is in accord with the intent and purpose of H.B. No. 1340, H.D. 2, S.D. 1, as amended herein, and recommends that it pass Third Reading in the form attached hereto as H.B. No. 1340, H.D. 2, S.D. 2.
DONOVAN M. DELA CRUZ, Chair