HB 43-NEW DRUGS FOR THE TERMINALLY ILL  4:00:30 PM CHAIR SPOHNHOLZ announced that the next order of business would be HOUSE BILL NO. 43, "An Act relating to prescribing, dispensing, and administering an investigational drug, biological product, or device by physicians for patients who are terminally ill; providing immunity related to manufacturing, distributing, or providing investigational drugs, biological products, or devices; and relating to licensed health care facility requirements." 4:00:49 PM BROOKE IVY, Staff, Representative Jason Grenn, Alaska State Legislature, stated that this legislation essentially allowed terminally ill patients to work with their doctors and drug or device manufacturers to access investigational treatments that had passed the safety testing phase, Phase 1 of the FDA (U.S. Food and Drug Administration) approval process, but had not yet passed Phase 2 and Phase 3 and were currently in ongoing trials, hence were not yet widely available for public access. She said that this could expand access to potentially lifesaving treatments years before normal access. She stated that, as fewer than 3 percent of those patients diagnosed as terminally ill who tried to access clinical trials were accepted based on the level of illness, this legislation would affect the other 97 percent. She added that a compassionate use program already existed with the FDA, which allowed for application by the doctor, although it was known to be a lengthy process which did not work well for those people with terminal illness. 4:02:26 PM REPRESENTATIVE SADDLER stated that mediation was already required between a health care provider and a patient which allowed for a process of testing and validation of drugs which the provider suggested. He asked if this was an argument for no remediation in order to allow a patient to try whatever substance they thought would help save their life or improve their health. MS. IVY replied that the actual language of the proposed bill defined a very specific situation for someone to have the ability to access this. She reiterated that currently there was a compassionate use application through the FDA, although it was strictly for individuals diagnosed as terminally ill, which required conference with their doctor, and then involved a lengthy FDA process and institutional review board. The proposed bill would maintain that the diagnosis was for terminally ill and that the patient had exhausted all other approved options, in consultation with the doctor, and would then require consent of the doctor, the patient, and the drug manufacturer for access to those medications. REPRESENTATIVE CLAMAN asked why this was limited to terminally ill patients, if someone was willing to try the experimental options. MS. IVY said that this question had come up previously and had been discussed in other states. She reported that similar legislation had passed in 33 states, and that this narrow focus was more likely to be supported in the courts. She stated that otherwise, this was, in essence, opening up the FDA drug approval process and created a larger policy conversation than the proposed bill wanted to tackle. She added that the proposed bill focused on individuals with limited time, as they had been diagnosed as terminally ill. REPRESENTATIVE EASTMAN acknowledged the conservative approach for the proposed bill, although he offered his belief that politics was driving the question of who gets care. He suggested that many Alaskans, although not expecting to die, could benefit from an experimental treatment and "may very well die even though they weren't expecting to." He declared that he "would certainly want to see what we could do for those folks, as well." He suggested that a more pro-active approach could be better, offering as an example Alaska's leadership for the legalization of marijuana. 4:07:44 PM CHAIR SPOHNHOLZ opened public testimony. 4:08:22 PM KEN LANDFIELD stated his support of HB 43, and questioned why this was even an issue. He said that any argument for creating a sense of false hope was not a valid argument, as "hope is hope and terminal is terminal." He declared that the compassionate use program was clearly not sufficient, otherwise, 60 percent of the state legislatures would not have enacted a bill similar to HB 43. He emphasized that time was "absolutely of the essence." He offered his support for the proposed bill "because, quite frankly, I can't think of any reason why you wouldn't." 4:09:38 PM ELIZABETH KROME, Nurse, shared that she had been a nurse for 38 years, working in multiple areas, and that she had learned that the removal of hope for a terminal condition was "the worst thing in the world that can happen." She offered her belief that everyone with a diagnosis for a terminal condition needs hope and that individuals need the option to try different treatments. She acknowledged the FDA experimental and investigational programs and clinical trials, but she added that they had very rigorous criteria. She stated her support for the proposed bill. She explained that the patient would have many roadblocks, which included the need for a physician to support them, to locate the drug, and to find an insurance company which would pay for treatment rather than deny coverage. 4:12:58 PM MIKE MAHARREY, National Communications Director, Tenth Amendment Center, reported that the Tenth Amendment Center had been in support of this "Right to Try" legislation across the United States, calling it the "no-brainer issue" because it was difficult to oppose. He reiterated that similar legislation had passed in 33 states. He stated that laws and regulations were supposed to protect the people, but, by their nature, regulatory schemes also created bureaucracy and red tape which could cause harm. He reported that HB 43 did not begin to address "the black hole between end of clinical trials and the final approval of the treatment. This process can take up to 10 months, and it often leaves patients in limbo." He offered an example of the benefits to patients from the passage of a similar "Right to Try" bill in Texas. He added that the Texas legislature was considering expansion of this bill to include chronically ill patients. He stated that this legislation illustrated the "beauty of our federated structure. The American system was never intended to run based on one size fits all solution imposed from Washington, DC." He spoke about the dangers of monopoly government. He declared that "Right to Try" laws were an example of states using their rights to authority to exercise control over local issues. He stated support of the proposed bill. 4:15:54 PM JASON NORRIS offered an example of his father's demise from ALS, pointing out that it affected the body, but not the mind. He recounted an article in the Washington Post about a man who had fought ALS using advanced therapies, which had led to his own awareness of the "Right to Try" movement. He implored passage of the proposed bill. 4:19:39 PM MS. IVY, in response to an earlier question from Representative Tarr, offered her understanding that federal legislation allowed for a quicker path for breakthrough medical devices and had directed the FDA to evaluate the use of real world evidence, observational studies, patient input, other research, and clinical trial data in order to approve drugs for other indications, and not simply for their initial studied use. She said that this did not directly impact the compassionate use program, however. She said that there was now a requirement for drug companies to publish on their websites their policies on how to access investigational drugs, which should make it easier to find out how to access these drugs. 4:21:53 PM MS. IVY clarified her earlier response to Representative Kito, and shared the four main points made by the Governor of Hawaii in his veto of similar legislation. These four main points included that the compassionate use program already provided access to investigational drugs, although the bill sponsor had pointed out that there was a delay through this process, which had resulted in the "Right to Try" legislation. The second point made by the Governor of Hawaii was that the bill could potentially interfere with the overall FDA system, and could result in the unintended consequence of delay for the development of potentially lifesaving drugs. She pointed out that the proposed bill did not compete with clinical trials. She relayed that the third point made by the governor was that it violated the supremacy clause, which had been discussed repeatedly during similar legislation debate in the many states, and had been declared a "floor not a ceiling." She stated that the final point from the governor had been that he was unclear what the actual benefits from the "Right to Try" could offer patients. She added that both the Hawaiian house and senate had unanimously passed this legislation. 4:23:46 PM MS. IVY addressed an earlier question from Chair Spohnholz about the definition for terminal illness. She stated that it appeared the definition used in the proposed bill came from Louisiana and Colorado legislation, and had since been used in "Right to Try" legislation in multiple other states. 4:24:24 PM MS. IVY referenced an earlier question from Representative Johnston regarding BCG medication, which had been developed as a vaccine for tuberculosis, although it was also being used to treat bladder cancers and melanomas. She referenced an earlier speaker from the Goldwater Institute, who had acknowledged that once a drug had been approved by the FDA, then off label use was permitted and legal. She offered her understanding that it was also permitted for a physician to prescribe an investigational drug which was in Phase 2 or Phase 3 for off label use. 4:25:33 PM MS. IVY turned attention to an earlier question from Chair Spohnholz whether informed consent, as referred to in the proposed bill, could include a verbal conversation between the doctor and the patient. She said that there was not any other place in Alaska statute where informed consent was defined; however, in the medical community and under medical ethics, it was accepted and understood that informed consent was different from consent in that the patient must understand. She said that whatever the form of communication, if the procedure, the other options, and the associated risks were fully understood, then Legislative Legal Services agreed that the current definition was broad enough. 4:27:00 PM CHAIR SPOHNHOLZ said that HB 43 would be held over.