ALASKA STATE LEGISLATURE  SENATE HEALTH AND SOCIAL SERVICES STANDING COMMITTEE  January 29, 2018 1:28 p.m. MEMBERS PRESENT Senator Natasha von Imhof, Vice Chair Senator Cathy Giessel Senator Peter Micciche Senator Tom Begich MEMBERS ABSENT  Senator David Wilson, Chair COMMITTEE CALENDAR  COMMITTEE SUBSTITUTE FOR HOUSE BILL NO. 43(JUD) "An Act relating to prescribing, dispensing, and administering an investigational drug, biological product, or device by physicians for patients who are terminally ill for the purpose of sustaining the patient's life; providing immunity related to manufacturing, distributing, or providing investigational drugs, biological products, or devices; and relating to licensed health care facility requirements." - MOVED CSHB 43(JUD) OUT OF COMMITTEE PREVIOUS COMMITTEE ACTION  BILL: HB 43 SHORT TITLE: NEW DRUGS FOR THE TERMINALLY ILL SPONSOR(s): REPRESENTATIVE(s) GRENN 01/18/17 (H) PREFILE RELEASED 1/13/17 01/18/17 (H) READ THE FIRST TIME - REFERRALS 01/18/17 (H) HSS, JUD 02/28/17 (H) HSS AT 3:00 PM CAPITOL 106 02/28/17 (H) Heard & Held 02/28/17 (H) MINUTE(HSS) 03/02/17 (H) HSS AT 3:00 PM CAPITOL 106 03/02/17 (H) Heard & Held 03/02/17 (H) MINUTE(HSS) 03/07/17 (H) HSS AT 3:00 PM CAPITOL 106 03/07/17 (H) Moved HB 43 Out of Committee 03/07/17 (H) MINUTE(HSS) 03/08/17 (H) HSS RPT 5DP 1NR 1AM 03/08/17 (H) DP: JOHNSTON, TARR, EDGMON, SULLIVAN- LEONARD, SPOHNHOLZ 03/08/17 (H) NR: KITO 03/08/17 (H) AM: EASTMAN 03/29/17 (H) JUD AT 1:00 PM GRUENBERG 120 03/29/17 (H) Heard & Held 03/29/17 (H) MINUTE(JUD) 04/03/17 (H) JUD AT 1:00 PM GRUENBERG 120 04/03/17 (H) Moved CSHB 43(JUD) Out of Committee 04/03/17 (H) MINUTE(JUD) 04/05/17 (H) JUD RPT CS(JUD) NT 5DP 1NR 04/05/17 (H) DP: EASTMAN, KOPP, FANSLER, LEDOUX, CLAMAN 04/05/17 (H) NR: REINBOLD 04/10/17 (H) MOVED TO BOTTOM OF CALENDAR 04/10/17 (H) MOVED TO BOTTOM OF CALENDAR 04/10/17 (H) TRANSMITTED TO (S) 04/10/17 (H) VERSION: CSHB 43(JUD) 04/11/17 (S) READ THE FIRST TIME - REFERRALS 04/11/17 (S) HSS, JUD 01/24/18 (S) HSS AT 1:30 PM BUTROVICH 205 01/24/18 (S) Heard & Held 01/24/18 (S) MINUTE(HSS) 01/29/18 (S) HSS AT 1:30 PM BUTROVICH 205 WITNESS REGISTER REPRESENTATIVE JASON GRENN Alaska Legislature Juneau, Alaska POSITION STATEMENT: Sponsor of HB 43. BROOKE IVY, Staff Alaska State Legislature Juneau, Alaska POSITION STATEMENT: Answered questions on HB 43. ACTION NARRATIVE 1:28:53 PM VICE CHAIR NATASHA VON IMHOF called the Senate Health and Social Services Standing Committee meeting to order at 1:28 p.m. Present at the call to order were Senators Giessel, Micciche, Begich, and Vice Chair von Imhof. HB 43-NEW DRUGS FOR THE TERMINALLY ILL  1:29:29 PM VICE CHAIR VON IMHOF announced the consideration of HB 43 relating to new drugs for the terminally ill. She noted that the committee heard from the sponsor during the first hearing and took public testimony. [CSHB 43, version 30-LS0207\J was before the committee.] 1:30:00 PM REPRESENTATIVE JASON GRENN, Alaska State Legislature, Bill sponsor, deferred to his staffer, Brooke Ivy, to answer questions previously raised by committee members. 1:30:16 PM BROOKE IVY, Staff, Alaska State Legislature, answered questions on HB 43. She noted that she would respond to the four questions raised during the previous committee meeting. Governor [David] Ige of Hawaii had vetoed Hawaii's Right to Try legislation in 2016. The current status of the legislation in Hawaii is that Right to Try legislation, SB 2268, was reintroduced in Hawaii on January 19, 2018. She reported that there are no set time limits for drugs in an investigational phase. The United States Food and Drug Administration (FDA) determines when a drug moves on to the next phase of the drug review process. She reported that it was difficult to determine how often drugs are distributed free of charge. Many patient assistance programs exist, whether through the manufacturer directly, patient networks, or research institutions. No public reporting by drug manufacturers is required. A journal article from 2009 stated that only four percent of drug manufacturers reveal the numbers of patients they assist. MS. IVY reported that it appears that most insurance companies do outline their clinical trials coverage in policies to avoid legal challenges. Premera is very clear in its material that it usually does not pay for experimental or investigational drugs or treatments. 1:35:42 PM SENATOR MICCICHE wondered why this did not become law earlier and what any opposition would be. MS. IVY said the most common opposition is the idea of false hope and to note that the FDA compassionate use program already exists. However, she said that the point of HB 43 is to streamline the FDA process and cut through the lengthy red tape. 1:37:08 PM SENATOR MICCICHE asked why Hawaii vetoed the bill. MS. IVY said Governor [Jerry] Brown in California vetoed this legislation in 2015, but later reversed his veto. But Hawaii Governor Ige noted that veto before Governor Brown later changed it. Governor Ige listed four reasons for vetoing the bill: 1. The FDA compassionate care process already provided access. 2. It intervened with the FDA system, which may have the inadvertent consequence of delaying new drugs. 3. It violated the supremacy clause. 4. He was unsure of patient benefits. She said the Hawaiian legislation passed without opposition in the Hawaiian House and Senate and she did not know why the governor's veto was not overridden. SENATOR BEGICH said he would not say that false hope is better than no hope at all. Any hope is better than no hope at all because some of these drugs do work. VICE CHAIR VON IMHOF asked if Premera provided a clause on how a person could petition to get coverage for experimental drugs. 1:40:08 PM MS. IVY read Premera's written policy that says denials for experimental or investigational drugs can be reviewed. VICE CHAIR VON IMHOF entertained a motion to move HB 43 out of committee. 1:40:58 PM SENATOR GIESSEL moved to report CSHB 43, version 30-LS0207\J, from committee with individual recommendations and attached zero fiscal note. 1:41:13 PM VICE CHAIR VON IMHOF found no objection and CSHB 43(JUD) moved from the Senate Health and Social Services Standing Committee. She noted that the bill moved with the understanding that Legislative Legal was authorized to make any necessary technical and/or conforming adjustments. 1:41:30 PM At ease. 1:43:59 PM There being no further business to come before the committee, Vice Chair Imhof adjourned the Health and Social Services Standing Committee at 1:43 p.m.