Legislature(2017 - 2018)BELTZ 105 (TSBldg)
02/28/2018 01:30 PM JUDICIARY
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HB 43-NEW DRUGS FOR THE TERMINALLY ILL 2:45:36 PM CHAIR COGHILL announced the consideration of HB 43. 2:46:15 PM REPRESENTATIVE JASON GRENN, Alaska State Legislature Juneau, Alaska, sponsor of HB 43, introduced the legislation speaking to the following sponsor statement: House Bill 43 would allow terminally ill patients who have exhausted other available treatments and do not qualify for clinical trials to 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. More than 1 million Americans die from a terminal illness every year. Many spend years searching for a potential cure, or struggle in vain to get accepted into a clinical trial. Unfortunately, FDA red tape and government regulations can often restrict access to promising new treatments, and sometimes for those who do get access, it is too late. 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. 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 have to wait. Since 2014, 38 states have signed "right to try" legislation into law with strong, bi-partisan support. It is clear this is a human issue that goes beyond state and party lines, and could provide Alaskans increased access to potentially life-saving treatments in the times they need it most. In allowing Alaskans facing terminal illness the ability to access safe, though experimental drugs in consultation with a doctor they trust, this bill offers new hope when all FDA-approved options have been exhausted. I urge your support of House Bill 43. REPRESENTATIVE GRENN read a letter of support from a constituent. I write to you today in support of HB 43 with the short title, "New Drugs for the Terminally Ill." In June 2011, my father was diagnosed with ALS, sometimes known as Lou Gehrig's disease. For those unfamiliar, this disease slowly saps a person's ability to move, rendering them bed-ridden. Eventually it takes away their ability to breathe at which point they die. For my father, this deterioration began in June. He had been working 12 hours days, five or six days a week as a machinist. He was, by all accounts, a very strong and health man at the time of his diagnosis. By late fall he had completely lost his ability to walk. At Thanksgiving, he held out five-month-old son for the last time in his arms as he had become to weak to be trusted with such precious cargo. In early morning of February 1, 2012, he died at the all too young age of 58. In the end I wish the State had afforded him the right to fight his disease. Recently in the Washington Post there was an article detailing the experience of a man who had, for all intents and purposes, beaten ALS through advance therapies pioneered by doctors at the ALS Center in Atlanta, Georgia. In reading about this man, I became aware of the Right to Try movement. I cannot say for sure that these advance therapies may have saved my father's life, but they may yet same someone's father, mother, daughter, or son. Thank you for your consideration on this important legislation. REPRESENTATIVE GRENN stated that the goal of HB 43 is to provide the same access as the FDA's Compassionate Use Program, but on a shorter timeline. That program recognizes that 97 percent of people are not accepted in clinical trials. HB 43 seeks to offer new hope when all other FDA approved options have been exhausted. 2:50:15 PM BROOKE IVY, Staff, Representative Jason Grenn, Alaska State Legislature Juneau, Alaska, paraphrased the following sectional analysis for HB 43: 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 or the marketing application process 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. Establishes immunity for physicians and manufacturers who choose not to participate in the distribution of an investigational drug, biological product or device. 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. CHAIR COGHILL asked if 97 percent of Alaskans have been denied clinical trials. MS. IVY replied that is a national number. She noted the clinical trials document in the packet has stories of Alaskans who have been admitted into clinical trials. CHAIR COGHILL asked her to discuss the FDA drug review process. MS. IVY explained that when a drug manufacturer's application for an investigational new drug (IND) is accepted, the drug moves into phase 1. The drug is studied for possible side effects and toxicity levels on healthy volunteers. Phase 2 looks at how effective the drug is for the condition. Phase 3 looks at safety again as well as effectiveness. CHAIR COGHILL asked if the informed consent form tells an individual they are part of a trial. 2:55:22 PM MS. IVY clarified that the volunteer would not be in a clinical trial, but the data related to the experimental drug would be collected and sent to the FDA. 2:57:32 PM CHAIR COGHILL held HB 43 in committee.