Legislature(2015 - 2016)BELTZ 105 (TSBldg)
04/11/2016 01:30 PM JUDICIARY
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SB 113-NEW DRUGS FOR THE TERMINALLY ILL 1:50:02 PM CHAIR MCGUIRE announced the consideration of SB 113. [This is the first hearing and CSSB 113(HSS) is before the committee.] 1:50:27 PM SENATOR WIELECHOWSKI, Alaska State Legislature sponsor of SB 113, introduced the bill speaking to the following sponsor statement: Senate Bill 113 would create a legal climate in which terminally ill patients who have exhausted other available treatments and do not qualify for clinical trials could gain faster access to safe, but experimental drugs in an effort to save their own lives. By providing certain immunities to prescribing physicians, manufacturers and distributors acting in good faith, this bill would allow terminal patients, in consultation with their doctor, the freedom to try new treatments as they fight to survive, without the burden of waiting for federal approval. The United States Food and Drug Administration currently offers an "expanded access" or "compassionate use" exemption that allows terminally ill patients that meet certain criteria to access drugs in the clinical trial phase, but not fully approved. However, even with recent efforts by the FDA to streamline the application process, this exemption program is known to be arduous and can take longer than patients facing terminal illness can wait. Since 2014, at least 44 states have seen "right to try" legislation introduced, 12 of which still have bills pending and 25 of which have signed bills into law with strong, largely unanimous, bi-partisan support. It is clear this is a human issue and one that goes beyond state and party lines. In providing terminal patients the ability to access safe, but experimental drugs in consultation with a doctor they trust, this bill offers new hope when all FDA-approved options have been exhausted. SENATOR WIELECHOWSKI said this bill is intended for the 97 percent of terminally ill people who apply for clinical trials but are not accepted. 1:52:28 PM BROOKE IVY, Staff, Senator Wielechowski Alaska State Legislature, explained that the goal of SB 113 is to create a legal climate so that terminally ill people can work directly with their doctor and the drug manufacturer to access experimental drugs that have passed phase 1 of the FDA review process. MS. IVY reviewed the sections of SB 113. Section 1: Prohibits disciplinary action of physicians by the State Medical Board for prescribing, dispensing or administering an investigational drug, biological product or device to terminally ill patients that are ineligible or unable to participate in a current clinical trial, have considered all other treatment options approved by the FDA and have provided written consent. Defines "investigational drugs, biological products and devices" as those that have successfully completed Phase 1 of the FDA drug review process and remain in ongoing Phase 2 or 3 clinical trials, but have not been approved for general use. Defines "terminal illness" as a disease that will result in death in the near future or permanent state of unconsciousness from which recovery is unlikely. Section 2: Establishes immunity for physicians, medical team members, manufacturers and distributors in the case of injury or death of a terminally ill patient from the use of an investigational drug, biological product or device, provided informed consent was obtained from the patient and notice of immunity was given in advance. Section 3: Amends statute limiting the sale and distribution of new drugs (AS 17.20.110) so as not to apply to physicians prescribing or administering investigational drugs under the conditions established in Section 1. Section 4: Prohibits the Department of Health and Social Services from requiring a licensed health care facility to increase its services solely to accommodate physicians prescribing, dispensing or administering investigational drugs to a patient. 1:55:12 PM KURT ALTMAN, Attorney, Goldwater Institute, Phoenix, Arizona, testified in support of SB 113. He related he is the drafter of the model legislation commonly referred to as "The Right to Try Bill" and he has traveled across the country advocating for the legislation. He pointed out that there are significant protections in the bill and that this is a last chance for terminally ill patients. For investigational medicine to be eligible under right to try laws, it has to have passed the safety testing phase 1 of the FDA approval process. More importantly, the drug must be in ongoing phase 2 or phase 3 clinical trials. He confirmed that this is for the 97 percent of terminally ill people who aren't accepted into clinical trials. By the end of this legislative session, he expects that quite a few more states will have passed similar legislation. This has been a two to three year process and patients are finally taking advantage of right to try laws, he said. 1:58:45 PM SENATOR COGHILL asked if there have been liability issues or families that feel somebody has been coerced into a treatment program. MR. ALTMAN said there has been no litigation to date with right to try laws. For someone to receive a trial drug, there has to be a detailed informed consent on behalf of the doctor and patient. In practice, the manufacturers that have agreed to provide these drugs also require a significant, detailed informed consent liability waiver. Each law that has passed has a similar liability waiver as SB 113 for any adverse effect from the investigational drug. It does not waive any claims of medical malpractice. SENATOR COGHILL asked how the prohibition in Section 4 will work. 2:00:53 PM MS. IVY said the provision seeks to allay concerns of health care facilities and hospitals about potentially losing their certificate for Medicare or Medicaid. Other states have passed this legislation with a similar provision. She noted that the Department of Health and Social Services (DHSS) has determined that SB 113 does not impact their operations due to that provision in SB 113. 2:02:11 PM MICHAEL MAHARREY, National Communications Director, 10th Amendment Center, testified in support of SB 113. He said that when the Center heard about the issue from the Goldwater Institute, they knew they could support it without reservation. SB 113 will take the decision-making process regarding a patient's treatment options out of the hands of detached individuals and put it where it belongs, with the patient and their physician. He commented on the FDA approval process for new drugs that is slow and cumbersome, and described right to try laws as a bridge that spans the gap between federal regulations and the needs of terminally ill patients. He urged the committee to pass SB 113. 2:04:52 PM CHARLOTTE WHITELEY, representing herself, testified in support of SB 113. She shared a story about her father who was able to participate in an experimental drug trial that helped him live an extra 3 years. It was particularly important to him to know that his data would be used to help future generations who get multiple myeloma. She also described the case of a friend with multiple sclerosis who participated in a drug trial in Switzerland. A new and better drug is being developed as a result of that trial. SB 113 allows people who are going to die from their disease, a chance to give to the future. 2:06:35 PM KEN LANDFIELD, representing himself, testified in support of SB 113. He said the situation is clear; the bill is designed to provide a last ditch option for someone who is going to die anyway. This is an opportunity for legislators to do the right thing and it has no downside he can see. Further, it will cost virtually nothing. 2:08:22 PM CHAIR MCGUIRE closed public testimony on SB 113. She shared a story about her physician father who made the decision to develop a pilot program after the FDA denied the use of an innovative scientific technique for his patients. SENATOR COGHILL asked if a report goes back to the FDA to add to the data on the experimental drug MS. IVY said SB 113 does not include reporting requirements but her understanding is that it is a requirement in the contracts with manufacturers under both compassionate use and right to try. SENATOR COGHILL expressed satisfaction. CHAIR MCGUIRE commented further on the pilot program her father developed. 2:13:23 PM SENATOR COGHILL moved to report the CS for SB 113, labeled 29- LS0783\E, from committee with individual recommendations and attached fiscal note(s). 2:14:04 PM SENATOR WIELECHOWSKI said he was surprised and pleased to learn that the Goldwater Institute supports the legislation. He credited his staff for doing comprehensive research and described SB 113 as good legislation that could save lives in Alaska. 2:14:25 PM CHAIR MCGUIRE announced that without objection, CSSB 113(HSS) is reported from Senate Judiciary Standing Committee.