Legislature(2017 - 2018)CAPITOL 106
02/28/2017 03:00 PM House HEALTH & SOCIAL SERVICES
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Audio | Topic |
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Start | |
HB25 | |
HB43 | |
Presentation: Reducing Use of Emergency Department Services | |
Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
*+ | HB 25 | TELECONFERENCED | |
*+ | HB 43 | TELECONFERENCED | |
+ | TELECONFERENCED | ||
+ | TELECONFERENCED |
HB 43-NEW DRUGS FOR THE TERMINALLY ILL 3:32:40 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." 3:32:49 PM REPRESENTATIVE JASON GRENN, Alaska State Legislature, shared that the proposed bill was often referenced nationally as "Right to Try" legislation. He stated that the goal of the proposed bill was: to create a legal climate in which terminally ill patients who have exhausted all FDA (U.S. Food and Drug Administration) approved treatment options may work with their doctors and drug manufacturers to access investigational and safe treatments that have passed Phase I of the FDA approval process but are not yet widely available. REPRESENTATIVE GRENN reported that "Right to Try" laws had been passed in 33 states, with this legislation being considered in another 15 states, now including Alaska. Paraphrasing from the Sponsor Statement [included in members' packets], he stated that, each year, it was estimated that more than 1 million Americans died from terminal illness. "For those who have exhausted all FDA approved options, clinical trials become the next step. However, of those patients who attempt to gain entry into a clinical trial, it is found that fewer than 3 percent are accepted." He declared that, although the FDA did have a program in place for accessing investigational drugs outside of clinical trials, which was known as the "Compassionate Use Program," it was estimated that only about 1200 people made it through the long, arduous federal process annually. He declared that the goal of the proposed bill was to provide the same access as the existing program but on a shorter timeline. He said that by assuring that terminally ill patients had more timely access to safe, though experimental drugs, in consultation with their doctor, the proposed bill would offer new hope after all FDA approved options had been exhausted. 3:35:02 PM BROOKE IVY, Staff, Representative Jason Grenn, Alaska State Legislature, presented a PowerPoint titled "House Bill 43: The Right to Try." She directed attention to the sectional analysis [included in members' packets] and to slide 2, "House Bill 43." She addressed Section 1 of the proposed bill, and stated that this section prohibited disciplinary action by the State Medical Board against physicians for prescribing or administering an investigational drug to a terminally ill patient who met certain criteria. She reported that patients had to be ineligible or unable to participate in an ongoing clinical trial, had considered all available treatment options in consultation with their doctor, and had provided written consent. She moved on to Section 2 of the proposed bill, which established that physicians, medical team members, manufacturers, importers, and distributors acting in good faith and with reasonable care would not be held liable in the case of injury or death of a terminally ill patient from the use of an investigational drug, provided that the informed consent was obtained from the patient and notice of immunity was also given to the patient in advance. She added that the section also established immunity for physicians and manufacturers who chose not to participate in the distribution of investigational drugs. She addressed Section 3 which amended AS 17.20.110, and would allow physicians to prescribe or administer investigational drugs under the conditions established in Section 1 of the proposed bill. She spoke about Section 4, which prevented the Department of Health and Social Services from requiring a licensed health care facility to increase its services, solely to accommodate physicians who were prescribing or administering investigational drugs to a patient. 3:37:37 PM MS. IVY directed attention to slide 3, "FDA Drug Review Process," and explained this process. She reported that, prior to Phase 1, the sponsors of a drug were required to submit an "Investigation New Drug" (IND) application, and through this application, the FDA reviewed the applicant's pre-clinical testing results, and then determined whether the drug was reasonably safe for testing in humans. MS. IVY spoke about slide 4, "FDA Drug Review Process (cont'd)," and explained that in Phase 1, the studies occurring after approval of the IND application, the studies could be conducted on healthy volunteers dependent on the purpose of the medication, or on individuals with specific diseases or terminal illness. She stated that safety to determine possible side effects and toxicity levels was the goal of Phase 1. She addressed slide 5, "FDA Drug Review Process (cont'd)," and spoke about the Phase 2 studies, which began when a drug was determined to be safe, and was focused on the effectiveness of the drug. She stated that, if there was evidence that a drug was effective, it moved on to Phase 3, slide 6, "FDA Drug Review Process (cont'd)." In Phase 3, more information was gained on safety and effectiveness, particularly in varying populations and in different dosages. After Phase 3, sponsors of the drug have a review meeting with the FDA, and submit a new drug application requesting approval to market the drug in the United States, slide 7, "FDA Drug Review Process (cont'd)." After this application, the FDA had 60 days to decide whether to file an application for review and then applications were generally processed within 10 months. 3:39:26 PM MS. IVY reviewed slide 8, and explained that investigational drugs had passed the safety testing in Phase 1, and were currently in ongoing clinical trials in Phase 2 and Phase 3 of the FDA process. 3:39:43 PM MS. IVY directed attention to slide 9, "FDA's Expanded Access Program," and spoke about the "Compassionate Use" program, which was designed for terminally ill patients without access to clinical trials so they could apply for these investigational treatments. She explained that the patient had to work with their doctor to apply directly to the FDA. She noted that, until recently, this application took more than 100 hours for a doctor to complete, but it had now been shortened. She acknowledged that this was still just the first step in the approval process. She added that manufacturers also had to submit lengthy documentation before the application went through the internal FDA approval process and on to a separate institutional review board, often a lengthy multi-month process. She reported that approximately 1200 applicants made it through the process annually. She addressed slide 10, "The Right to Try - A Nationwide Effort," and pointed out that this legislation had been passed or was under consideration in all but one state. 3:41:20 PM REPRESENTATIVE SULLIVAN-LEONARD, referencing slide 9, asked how many applicants did not make it through the process. MS. IVY said that she did not have that number. REPRESENTATIVE SULLIVAN-LEONARD offered her belief that it was an important component to the proposed bill. 3:42:05 PM MS. IVY pointed to the Clinical Trials document [included in members' packets] which included stories of Alaskans facing terminal illness and the benefit of having access to the drugs. She stated that, additionally, there was a Goldwater Institute policy report [included in members' packets] which delved into greater detail for the challenges of the Compassionate Use program. REPRESENTATIVE TARR asked for an update to the policy signed by President Obama prior to leaving office, which had included some provisions to expand drug trials for non-approved drugs, and for its interaction to the proposed bill. MS. IVY said that she would research the specifics. 3:44:18 PM REPRESENTATIVE KITO asked why the legislation was vetoed in Hawaii. MS. IVY replied that, although the legislation had passed unanimously from the legislature in Hawaii, the governor had vetoed it. She shared that Governor Brown in California had also vetoed the legislation, but had since changed his mind, purportedly because of instances of benefits to patients in Texas. 3:46:00 PM REPRESENTATIVE KITO referenced the statement from the bill sponsor that this was an opportunity for individuals who have terminal illnesses to try something that was not a standard procedure. He offered his belief that there might be opportunities for treatment benefits prior to waiting until a diagnosis of terminal illness. He asked why it was necessary to wait to prescribe a potential remedy until a terminal diagnosis. MS. IVY replied that the national advisors on this legislation had suggested to keep a narrow focus, as this was something already available through the FDA. She pointed out that taking on preventative care with all medications that go through the FDA approval process was a much larger federal policy discussion regarding the approval of drugs in the U.S. 3:47:59 PM CHAIR SPOHNHOLZ added that, as medications had side effects, an important part of the FDA approval process was to ensure that the medication was safe, did what it claimed, and its benefits outweighed the costs. The FDA approval process was set up to protect consumers. She offered an example of aspirin being taken to prevent heart problems, whereas it actually increased gastric problems as a side effect. She pointed out that experimental drugs needed to be proven safe. She asked for the definition of terminally ill in the proposed bill. MS. IVY directed attention to page 2, line 12 of the proposed bill, and she read: "terminal illness" means a disease that, without life- sustaining procedures, will result in death in the near future or a state of permanent unconsciousness from which recovery is unlikely. 3:50:43 PM LINDA BRUCE, Attorney, Legislative Legal Counsel, Legislative Legal Services, stated that this was a new definition which had been drafted for this bill. MS. IVY offered her belief that the definition came from model legislation in other states. 3:51:32 PM REPRESENTATIVE SULLIVAN-LEONARD asked whether the information collected from terminally ill patients could be used for other patients. MS. IVY replied that the data from investigational drugs, used outside a clinical trial, was being collected and that federal law dictated that manufacturers needed to provide this information to the FDA. She offered her belief that it was required that the data be collected. 3:53:16 PM REPRESENTATIVE TARR commented that this was Rare Diseases Awareness Day. She shared that, as there was not a large enough population to have statistically relevant information for appropriate interventions, it was often a fight to get access to medication. 3:54:50 PM STARLEE COLEMAN, Vice President, Communications, Goldwater Institute, reported that her organization had crafted the language on which proposed HB 43 was based, although, she acknowledged, there had been some Alaska specific adjustments. She relayed that diagnosis for a terminal illness currently offered three paths of approved options for the access to promising investigational treatments: the first path was for the clinical trials; the second path was for those who could afford to travel overseas to access drugs that were already available in countries other than the U.S; the third path was for the connected, the aforementioned FDA "Expanded Access" program. For the remainder of the public, there was no path to access investigational treatments, hence the "Right to Try" program. She stated that it was important to understand that this program was the opposite of the right to die movement, which was for people ready to end their own lives. The "Right to Try" program allows patients with terminal illnesses who had tried existing treatments with no success, and could not enroll with a clinical trial, to access promising treatments being safely used in government approved clinical trials. She pointed out that it was not a question for whether or not trying an investigational treatment was too risky, as the risk from these treatments was exactly the same as for those entered into government clinical trials. She emphasized that it was hard to be selected for a clinical trial. She offered an example of clinical trials for children diagnosed with spinal muscular atrophy (SMA). She reported that 97 percent of cancer patients had to rely on drugs already on the market, even if a drug in a clinical trial was being developed specifically for their type of cancer, and had already been approved in other countries. She reiterated that, although about 1200 people annually made it through the application process, it was not known how many people were declined as FDA did not keep records. She reported that, although the FDA declared that its approval rate was about 99 percent, she had questioned this rate. She offered an example of a cancer trial center in Houston, the largest in the world, which claimed that it had only been able to get one person through the FDA "Expanded Access" process annually. She surmised that many doctors spoke to the FDA in advance and would not apply if the FDA stated they would not accept the application. She pointed out the difficulty for doctors in Alaska who were not familiar with the FDA process or hierarchy. She compared the FDA program with a similar program in France which treated 25,000 people annually, and declared that there was a problem with the FDA program. 4:04:00 PM MS. COLEMAN stated that, although no one expected a guarantee that an investigational drug would offer a cure, they just wanted an opportunity to try the medications already being used in clinical trials. She declared that dying people and their families were owed that opportunity. She stated that "Right to Try" was already working and saving lives. She offered an example of terminal pancreatic cancer patients. She emphasized that states were able to do this to complement the federal drug approval process, and not compete with it. She declared that the right to save your own life was a human right, and that it should not be necessary to also fight government red tape. 4:05:49 PM REPRESENTATIVE JOHNSTON asked for clarification that the proposed bill was for the right to try drugs that had gone through the first, second, and third steps toward FDA approval. MS. IVY replied that all of these drugs had passed Phase 1 for safety testing and were currently in Phase 2 or Phase 3. REPRESENTATIVE JOHNSTON asked if drugs allowed in Europe had already passed Phase 1 by the FDA, and were also in Phase 2 or Phase 3. MS. IVY replied that was correct. She stated that in some countries medications or treatments were in general use, and considered safe and effective, but had not yet gone through Phase 1 of the FDA process in order to be eligible under the "Right to Try" program. She pointed out that a person could travel to that country and utilize the medication, but that was outside this process. MS. COLEMAN offered an example for five FDA investigational treatment drugs for breast cancer which had been approved in other countries. She stated that "Right to Try" would allow those treatments already in use to become available to American women. 4:07:59 PM CHAIR SPOHNHOLZ asked how many people had taken advantage of the access to "Right to Try." MS. COLEMAN replied that there was not a complete record for that information, as there was not a state specific reporting requirement for the use of drugs in a state with a "Right to Try" law. She noted that this would be duplicative of drug company reports to the FDA, adding that the FDA did not make this information available under public records laws. 4:09:27 PM REPRESENTATIVE JOHNSTON asked if a drug would qualify if it was used for one treatment, even though its purpose was for something else. She pointed out that it had already gone through the Phase 1 safety test, but not through the next phases. MS. COLEMAN said that she would need more specifics about the drug's placement in the trial process. She reiterated that the goal of "Right to Try" was to provide access for terminal patients to any drug which had passed the initial safety trial, and was in on-going trials and under active investigation. She said that it was legal for drugs to be used for another purpose, which she termed "off label use." 4:11:28 PM REPRESENTATIVE TARR expressed concern for the provision of immunity, noting that medical malpractice provisions were still in place, and asked if this had been an issue in any other states. She asked if there was protection for an individual who felt pressured or coerced into taking a drug. MS. COLEMAN shared this concern that patients were protected from any undue pressure to try something they were not fully comfortable with and to protect them from medical malpractice. She shared that the proposed bill had two patient protections: (1) that a patient must voluntarily sign a comprehensive, informed consent document, and (2) that this was totally voluntary with no incentive for the pharmaceutical company to participate. She said that medical malpractice laws were not impacted by the proposed bill, and these laws would remain in place. She declared that a point of the liability shield was to ensure that doctors, hospitals, and pharmaceutical companies understand that should a patient in a terminal situation die while taking an investigational treatment, that, in and of itself, was not a reason to be sued. 4:15:05 PM MS. IVY added that there were other protections in the proposed bill, as it included investigational drugs in on-going trials. She offered her belief that, under federal law, manufacturers cannot engage in the marketing and sale of unapproved drugs, and were not legally permitted to sell investigational drugs for more than the production cost. She stated that this removed the cost benefit for manufacturers to participate. CHAIR SPOHNHOLZ asked whether the informed consent described in the proposed bill included a verbal discussion for the risks and benefits. MS. IVY, in response to Chair Spohnholz, expressed her agreement and added that discussion would include all available treatment options currently approved by the FDA. CHAIR SPOHNHOLZ directed attention to page 2, lines 26 - 27, as the guarantee of a verbal conversation with the doctor regarding the risks and benefits of a potential treatment, and that writing was a codification of that consent. MS. IVY expressed her agreement that this was the intent of the proposed bill, and expressed her support of any necessary amendment to clarify the requirement for a verbal conversation. 4:18:24 PM CHAIR SPOHNHOLZ said that HB 43 would be held over and public testimony would be opened at that time.
Document Name | Date/Time | Subjects |
---|---|---|
HB025 ver A 2.16.17.PDF |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
HB025 Sponsor Statement 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
HB025 Sectional Analysis ver A 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
HB025 Supporting Document-Cost Savings Study 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
HB025 Supporting Document-ADN Commentary 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
HB025 Supporting Document-Guttmacher Alaska Statistics 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
HB025 Supporting Document-Guttmacher Public Costs from Unintended Pregnancies 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
HB025 Supporting Document-Letter Kachemak Bay Family Planning Clinic 2.23.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
HB025 Supporting Document-Letter League of Women Voters Alaska 2.24.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
HB025 Supporting Document-Unintended Pregnancies Study 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
HB025 Supporting Document-Letter Planned Parenthood Votes Northwest & Hawaii 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
HB025 Supporting Document-UCSF Study Newspaper Article 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
HB025 Supporting Document-Letter Dr. Tina Tomsen 2.27.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
HB025 Supporting Document-Support Emails 2.27.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
HB025 Opposing Document-America's Health Insurance Plans 2.27.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
HB025 Opposing Document-Letter NFIB 2.16.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
HB025 Fiscal Note DHSS-Medicaid Services 2.28.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
HB025 Fiscal Note DHSS-DHCS 2.28.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
HB025 Fiscal Note DCCED-DIO 2.28.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/9/2017 3:00:00 PM HHSS 4/6/2017 3:00:00 PM HHSS 4/11/2017 3:00:00 PM |
HB 25 |
HB043 ver D 2.22.17.PDF |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
HB043 Sponsor Statement 2.22.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
HB043 Sectional Analysis ver D 2.22.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
HB043 Supporting Document - Legislative Map 2.22.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
HB043 Supporting Document - FDA Drug Review Process 2.22.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
HB043 Supporting Document - Clinical Trials in Alaska.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
HB043 Supporting Document - Goldwater Institute Fact Sheet 2.22.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
HB043 Supporting Document - Goldwater Institute Patient Stories 2.22.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
HB043 Supporting Document - Goldwater Institute Policy Report Summary 2.22.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
HB43 Supporting Document - Letters of Support 2.27.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
HB043 Fiscal Note DCCED--DCBPL 2.28.17.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
HB 43 Powerpoint Presentation.pdf |
HHSS 2/28/2017 3:00:00 PM HHSS 3/2/2017 3:00:00 PM HHSS 3/7/2017 3:00:00 PM |
HB 43 |
AK ED Coordination Project from SB 74 to H HSS.pdf |
HHSS 2/28/2017 3:00:00 PM |