Legislature(2017 - 2018)ADAMS ROOM 519
04/11/2018 01:30 PM FINANCE
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SENATE BILL NO. 32 "An Act relating to biological products; relating to the practice of pharmacy; relating to the Board of Pharmacy; and providing for an effective date." Co-Chair Foster relayed that SB 32 was last heard in committee on May 3, 2017. 3:36:12 PM SENATOR SHELLEY HUGHES, SPONSOR, provided a review of the legislation. She reported that since the bill was last heard the Alaska Board of Pharmacy decided to support the bill and that 41 states adopted similar legislation; an increase from 33 in 2017. She detailed that a biologic was made from a living cell and had a complex molecular structure. The drugs were the fastest growing type of "therapeutic products." Approximately three dozen biologic medicines were used to treat serious and chronic diseases for thousands of Alaskans. Additionally, a generic drug could be substituted by a pharmacist because it contained "identical chemical recipe." Biological products differ from traditional generics and were not able to replicate exactly due to its complex compounds therefore generic biologic medicines were not identical and were considered "biosimilar." The federal Food and Drug Administration (FDA) developed a "gold standard" or criteria for biosimilar products and labeled them "interchangeables." An interchangable biosimilar was highly similar to the original biologic and had been found to produce similar clinical results. The bill would update current laws to allow a pharmacist to substitute interchangeable biosimilars for prescribed brand-name biologics that were approved by the FDA but maintained the prescribers control by authorizing them to specify whether a substitution was allowable. Patient consent was also required before any substitution was made. The chemical results would be the same. The legislation required that within three days after dispensing, the pharmacist must communicate to the physician the specific biologic product dispensed. 3:40:38 PM Representative Kawasaki asked whether patient consent for the substitution was necessary. Senator Hughes responded in the affirmative. Representative Kawasaki asked about the gold standard for interchangeable biosimilars and wondered what the standard was. Senator Hughes replied that the FDA's definition of an approved biosimilar was that the "interchangeable would produce the same clinical result as the referenced product in any given patient." Representative Kawasaki asked how the process worked when the pharmacist communicated to the prescribing practitioner what specific biologic substitute was dispensed. Senator Hughes relayed that it would happen via an electronic system, emails, or phone calls and allowed 3 business days for the communication. Co-Chair Foster moved to invited testimony. 3:44:29 PM Co-Chair Foster OPENED public testimony. 3:44:58 PM RICHARD HOLT, CHAIRMAN, BOARD OF PHARMACISTS, ANCHORAGE (via teleconference), indicated that the board supported SB 32. He reported that the field of biologic medicine was rapidly growing, and the board needed to stay focused on the industry. He noted that currently Alaskan pharmacists would not be able to offer interchangeables and was in full support of the bill. Representative Wilson related that the board would be required to post and maintain a link to the FDA's list of all currently approved interchangeable biological products on the board's website. She asked whether the board was in support of the requirement. Mr. Holt replied in the affirmative. 3:47:16 PM MARC BOAS, SELF, ANCHORAGE (via teleconference), was a current patient with the chronic illness, psoriasis. He spoke in support of SB 32. He indicated that he was an advocate for a chapter of the National Psoriasis Foundation. He delineated that conventional drug treatment results diminished over time. Biosimilars offered significant relief and cost savings. He believed the bill provided the correct pathways to gain access to the appropriate interchangeables while protecting the patient. He urged members not to delay passage of the bill. He thanked members for their support. 3:49:41 PM AT EASE 3:49:56 PM RECONVENED Co-Chair Foster would be passing the gavel to Vice-Chair Gara. SHAINA SMITH, U.S. PAIN FOUNDATION, WASILLA (via teleconference), spoke in favor of the legislation. She read from a foundation member's letter who was a decorated veteran and experienced chronic pain for over 45 years. He relayed his experience with relief from rheumatoid arthritis from a biologic medicine. He supported the opportunity to have an FDA substitution in the case he built resistance to his current biologic. He supported the bill. 3:52:08 PM ASHLYN ANTONELLI, SELF, ANCHORAGE (via teleconference), spoke in favor of the bill. She shared that she was a brain tumor survivor and currently struggled with psoriatic arthritis and provided details about her health. She supported the ability to be prescribed a biosimilar substitute and noted that many other states had approved the substitutions. She related that her pain was debilitating, and she had to take a three-hour nap when she got home from work. She hoped the committee would put itself in the position of a person with chronic illness to understand the need for supporting the legislation. 3:55:11 PM TERRY MCCLELLAND, SELF, ANCHORAGE (via teleconference), testified in support of the bill. He related that he was a volunteer for the Colorectal Cancer Alliance. He shared that he had cancer twice and was medically prohibited from receiving any further chemotherapy or radiation. He wanted the bill to pass to ensure all Alaskans had access to other options. 3:56:50 PM Vice-Chair Gara noted he was signing on as a co-sponsor for the bill. Vice-Chair Gara CLOSED public testimony. 3:57:24 PM AT EASE 3:58:14 PM RECONVENED Representative Guttenberg asked what the difference between a biologic and biosimilar was. RYLAN HANKS, DIRECTOR OF REGULATORY POLICY, AMGEN, LOS ANGELES, CALIFORNIA (via teleconference), replied that since biologics were made with living cells exact replications were impossible. He explained that a patient's immune system recognized the biologic by responding in certain ways to the small molecules. Because of the slight differences in the small molecules between a biologic and biosimilar, the biosimilar was not an exact copy. The way a biosimilar reacted in the body was highly similar but not exactly the same. Senator Hughes appreciated the committee's time. She commended her staff, Aimee Bushnell, for working hard on the bill. Vice-Chair Gara MOVED a conceptual amendment. Representative Wilson OBJECTED for discussion. Vice-Chair Gara explained Conceptual Amendment 1. He cited that on page 4, line 17, the effective date was changed from July 1, 2017 to July 1, 2018 and on page 4, line 18 the year 2018 was changed to 2019. Representative Wilson WITHDREW her OBJECTION. There being NO further OBJECTION, Conceptual Amendment 1 was ADOPTED. Representative Kawasaki asked whether the bill applied specifically to interchangeable biological products only. Senator Hughes replied in the affirmative. She detailed that an interchangeable was a sub-category of a biosimilar and only an interchangeable biosimilar could be substituted. Representative Kawasaki pointed to an FDA document and read the following: An interchangeable biological product may be substituted for the reference product by a pharmacist without intervention by a healthcare provider who prescribed the product? Representative Kawasaki restated his question regarding the provision that the pharmacists must notify the prescriber of the substitution. Senator Hughes answered that the FDA did not require pharmacist's notification. However, patient groups across the country requested the notification and all 41 states included the notification requirement in response to public outcry. 4:03:54 PM Vice-Chair Gara reviewed the new fiscal impact note from the Department of Commerce, Community and Economic Development (DCCED) in the amount of $4,500 for the regulatory process. Vice-Chair Gara MOVED to REPORT HCS SB 32(FIN) out of committee with individual recommendations and the accompanying fiscal note. There being NO OBJECTION, it was so ordered. HCS SB 32(FIN) was REPORTED out of committee with a "do pass" recommendation and with one new fiscal impact note from the Department of Commerce, Community and Economic Development. 4:05:55 PM AT EASE 4:06:52 PM RECONVENED