Legislature(2015 - 2016)BUTROVICH 205
02/24/2016 01:30 PM HEALTH & SOCIAL SERVICES
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SB 113-NEW DRUGS FOR THE TERMINALLY ILL 1:32:09 PM CHAIR STEDMAN announced the consideration of SB 113. 1:32:59 PM SENATOR GIESSEL moved to adopt the CS for SB 113, labeled 29- LS0783\H, as the document before the committee. CHAIR STEDMAN objected for discussion. 1:33:17 PM SENATOR BILL WIELECHOWSKI, Alaska State Legislature, as sponsor, introduced SB 113. He noted that the bill is called the "Right to Try Act." It allows terminally ill patients to work with their doctors and drug or device manufacturers to access investigational treatments that have passed the Federal Drug Administration's (FDA) safety testing phase - Phase 1 - but are not yet widely available. More than a million Americans die every year from terminal illness. CHAIR STEDMAN requested to hear the change made in the CS. 1:34:06 PM BROOKE IVY, Staff, Senator Wielechowski, Alaska State Legislature, explained the changes in version H of SB 113. She reported that SB 113 has had three iterations; version A, version W, and now version H. She related that in version H on page 1, line 10, provisions to prevent any damage to clinical trial participation were added by ensuring that patients had already attempted to enter a clinical trial. The language in Section 1 states that patients must be "ineligible or unable to participate in a clinical trial" as part of their condition. MS. IVY related that on page 2 of Section 1, the requirement for hospitals and healthcare facilities to participate was repealed. Language was added that the investigational drug shall remain in an on-going clinical trial in order to clarify that the investigational drug is in Phase 2 or Phase 3 of the FDA approval process. She said on page 2, line 21, immunity protections for medical team members, in addition to physicians, was added. On page 3, line 12, a fourth section was added because the previous section was repealed. Section 4 says it is optional for hospitals and healthcare facilities to participate in order to accommodate physicians prescribing, dispensing, or administering investigational drugs to a patient, and DHSS cannot require them to do so. 1:36:39 PM MS. IVY said in Section 4 of version W, it stated that "a licensed entity may not be subject to investigation or an enforcement action for failing to increase services." The only change from version W to version H was stating that the department may not be required to provide additional services. 1:37:20 PM CHAIR STEDMAN removed his objection. There being no further objection, version H was adopted. He noted the presence of Senator Stoltz. 1:38:22 PM SENATOR WIELECHOWSKI explained the origins of SB 113. He said the bill is known as the "Right to Try Act" and has passed in 24 states and been introduced in virtually every other state. He related that SB 113 sets up a legal framework that allows terminally ill patients to work with their doctors and drug and device manufacturers to access investigational treatments that have been passed the FDA's safety testing phase, but are not widely available. It would expand access to potentially life- saving treatments years before patients would normally be able to access them. The problem is the bureaucratic process in the FDA can take years, and fewer than 3 percent of terminally ill patients gain access to treatments through clinical trials. This legislation is designed to try and make those treatments available to the other 97 percent. He noted he worked on the legislation with Kurt Altman, an expert from the Goldwater Institute in Arizona. He emphasized that this issue cuts across party lines. It enjoys overwhelming bi-partisan support in the states where it has passed. MS. IVY explained that the goal of the bill is to create a legal climate in which terminally ill patients, who have exhausted all FDA-approved treatment options, may work with their doctors and drug manufacturers to access investigational treatments that have passed Phase 1 of the FDA approval process, but are not yet widely available. MS. IVY said version H has four sections: Section 1 of the bill prohibits the State Medical Board from taking disciplinary action against physicians for prescribing or administering an investigational drug to a terminally ill patient that meets certain criteria. Patients under this section must be ineligible or unable to participate in an ongoing clinical trial, have considered all other approved treatment options and have provided written consent. Section 2, a new section in AS 09.65, establishes that physicians, medical team members, manufacturers, importers and distributors, "acting in good faith and with reasonable care," will 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 informed consent was obtained from the patient, and notice of immunity was also given to the patient, in advance. Section 3 adds a new section to AS 17.20.110, a statute limiting the sale and distribution of new drugs. The new section will allow physicians to prescribe or administer investigational drugs under the conditions established in Section 1. Finally, Section 4 would prevent the Department of Health and Social Services from requiring a licensed health care facility to increase its services solely to accommodate physicians who are prescribing or administering investigational drugs to a patient. 1:42:12 PM MS. IVY reviewed the four phases of the FDA drug review process: Prior to Phase 1 is when sponsors of a drug are required to submit what's called an Investigational New Drug (or IND) Application - it is through this application process the FDA reviews the applicant's preclinical testing results and determines whether the drug is reasonably safe for testing in humans. Phase 1 studies occur after the approval of the Investigational New Drug Application. These studies may be conducted on healthy volunteers in cases of testing on drugs like ibuprofen or anti- inflammatories, or on individuals with a specific disease or terminal illness. The goal of Phase 1 testing is to determine possible side effects and toxicity levels. Basically, Phase 1 focuses on safety. Phase 2 studies begin when a drug passes Phase 1 and is therefore considered relatively safe (no unacceptable toxicity levels). While Phase 1 focuses on safety, Phase 2 focuses on a drug's effectiveness. If there is evidence a drug is effective, it will then progress to Phase 3. This is where more information is gained on safety and effectiveness, particularly in varying populations, at different dosages and in combination with other medications. After Phase 3, sponsors of the drug then have a review meeting with the FDA, and go on to complete a New Drug Application, which if approved, would allow them to market the drug in the United States. From there the FDA has 60 days to decide whether to officially "file" the application for review. If filed, applications are generally processed within 10 months. 1:44:24 PM MS. IVY explained that when the term "investigational drugs" is used in Senate Bill 113, it refers to those experimental drugs that have passed safety testing in Phase 1, and that remain in ongoing clinical trials in either Phase 2 or Phase 3 of the FDA approval process. She addressed the purpose of the legislation. Each year, it is estimated that over one million Americans die from a terminal illness. Many individuals diagnosed with a fatal condition may spend years searching for a cure or a viable treatment. 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. In recognition of the 97 percent of patients denied access to clinical trials, the FDA does have a program in place for accessing investigational drugs outside of clinical trials, known as the "compassionate use" program. Nevertheless, it's estimated that only about 1,000 people make it through this federal process each year. By the FDA's own estimate, the program's application form alone can take 100 hours for a doctor to complete. In an effort to streamline the process, the FDA did announce plans in February of 2015 to shorten the application. However, a year has now passed and the new form has yet to be made available. The application is only the first step. Manufacturers must also submit lengthy documentation. Once complete, application paperwork must then make its way through the FDA, and then to a separate Institutional Review Board for approval, an often lengthy, multi-month process. 1:46:38 PM She stated that given this information, the goal of Senate Bill 113 is to provide the same access as the FDA's existing "compassionate use" program, but on shorter timeline. By ensuring terminally ill patients have more timely access to safe, but experimental drugs, in consultation with their doctor, SB 113 attempts to offer new hope when all FDA-approved options have been exhausted She noted items in members' packets: 1) An Updated NCSL Legislative Map (1-4-2016). Although this th map was published on January 4 of this year, it is already out of date. As of today, 47 states have now seen "Right to Try" legislation either introduced or passed. Of those, 24 states have signed the "Right to Try" into law with overwhelming bi-partisan, and often unanimous, support. The Indiana - (H), Georgia - (H), Texas - (S), Nevada - (H&S), North Carolina - (H&S) are just a sampling of legislative bodies that put their unanimous support behind the "Right to Try." 22 states also currently have legislation pending, including Alaska. For the record, this now adds WA, ID, KS, KY, WV, GA, SC, MD, RI & VT to the map as "pending." Please also note the map contains an error: NH has not yet passed the "Right to Try," but it is currently pending. 2) Sponsor Statement - note that state legislation numbers reference in the sponsor statement, being based on this map, are now incorrect. 3) Goldwater Institute Policy Report - an abbreviated version of the Goldwater Institute's Policy Report. The Policy Report goes into greater detail on the challenges of the FDA's "compassionate use" program, and tells the story of Kianna Karnes, a 41 year old diagnosed with kidney cancer who passed away before she could receive access to an investigational drug that may have helped her. To read a quick excerpt from the executive summary: "In the case of Kianna Karnes, she had a better chance than most patients at receiving expanded access. As her father explained, "Here is a case where her old man understood clinical trials. I knew about compassionate use; I had a friendship with a powerful member of Congress; I've got the Wall Street Journal behind me. But I still couldn't save her life. Now, what about the thousands of people out there who don't have these kinds of resources available to them?" To most patients, and many physicians outside of major institutions, the process of obtaining expanded access is excessively time-consuming and extremely difficult to navigate." For those members who are interested, the full report is now available on Basis. 4) Clinical Trials - a document entitled "Clinical Trials." While SB 113 focuses on terminally ill patients who do not qualify for clinical trials, we felt the inclusion of these Alaskan stories would help to illustrate local experiences with terminal illness, as well as the benefit of simply having access to new treatment options, clinical trial or not. 1:49:50 PM SENATOR STOLTZE requested a definition of biological products and information whether FDA's testing "not doing harm" must also "show that it does good." 1:50:28 PM MS. IVY deferred to Mr. Altman to answer. SENATOR STOLTZE voiced concern about product contents leading to false hopes. CHAIR STEDMAN opened public testimony. 1:52:45 PM KURT ALTMAN, Counsel, Goldwater Institute, presented information about SB 112. He said he is the drafter of the model legislation SB 113 is generally fashioned after. He said he has been to about 30 to 35 states and has met with stakeholders, legislators, legal panels, FDA doctors, pharmaceutical companies, and insurance companies for about two years. He explained that the bill would allow terminal patients, on the recommendation of their physicians, to access investigational new drugs, biologics, or devices that have passed Phase 1 of FDA testing and remain in the testing process. He said a common misperception is that a drug can pass Phase 1 and be marketed to desperate people. The "Right to Try" was designed to prevent that and there are a number of safeguards. A company cannot get a drug through Phase 1 and then market it to the public. 1:56:24 PM MR. ALTMAN continued to describe the FDA approval process and stressed that the bill does not take people away from clinical trials. He used the cell phone as an example of how technology has advanced and compared it to medical technology advances, which have often outpaced the FDA process. Many drugs are in their 12th year of clinical trials and it is nearly impossible for patients to access those drugs. The bill would keep the access to these drugs between the doctor and the patient. 1:58:37 PM MR. ALTMAN defined biological products as cells - plant or human - that are injected into the body. He said there is a significant concern about charlatans trying to take advantage of desperate people. Right to Try has made that nearly impossible because the drug has to pass FDA's Phase 1 and remain in Phase 2 or 3. That means it is a legitimate drug and it would be provided for free or for cost of production. Federal statute prohibits any profit to a company for sale of a drug that has not been officially approve for marketing. The process is designed not to make money off of desperate people. 2:01:16 PM SENATOR STOLTZE asked if the cells could be from an aborted child. MR. ALTMAN said no. SENATOR STOLTZE questioned, "Absolutely no?" MR. ALTMAN replied, "Absolutely no." 2:02:20 PM MICHAEL MAHARREY, National Communications Director, 10th Amendment Center, testified in support of SB 113. He said his organization has been involved in, and supportive of, the Right to Try from the beginning. He provided statistics related to the time it takes to get a drug approved. He said the bill is a perfect example of states exercising their rightful authority to exercise control over local issues. It would expanded access to treatments for the desperately ill. 2:05:47 PM KEN LANDFIELD, representing himself, testified in support of SB 113. He referred to the Hippocratic Oath to do no harm, and wondered how much harm could be done to a terminally ill person under guidance of their physician. He thought the Right to Try should be an option. SENATOR WIELECHOWSKI said he appreciated the opportunity to present SB 113. He concluded it is an important bill that crosses party lines and potentially saves lives. CHAIR STEDMAN held SB 113 in committee.