SB 32-PRESCRIPTIONS FOR BIOLOGICAL PRODUCTS  1:58:35 PM CHAIR WILSON called the committee back order. He announced the consideration of SB 32. He summarized that the committee heard a bill overview and had taken public testimony on February 10. He asked that Senator Hughes, the bill sponsor, provide final comments on SB 32. 1:59:06 PM SENATOR SHELLEY HUGHES, Alaska State Legislature, Juneau, Alaska, sponsor of SB 32, stated she was available to answer questions. SENATOR BEGICH noted that he received a letter from the Alaska State Medical Association (ASMA) that indicated opposition to SB 32. He detailed that ASMA proclaimed that SB 32 was not as permissive as it needed to be because biosimilars are perceived by the FDA to be considerably safe. SENATOR HUGHES replied that she was surprised by the ASMA letter because she received an earlier letter from a physician who requested notification and prior authorization. She remarked that ASMA has indicated their belief that the FDA process and approval of biosimilars for substitution at the "silver standard" level would be fine versus the "gold standard" of interchangeable. She opined that biosimilars are new and because the FDA does plan to have additional criteria for the interchangeable "gold standard," SB 32 should be left as is in order to provide another level of safety. She set forth that a prescriber needs to stay in the "driver's seat" with the ability to write, "Dispense as written" or "Call if substitute available". SENATOR HUGHES detailed that the FDA criteria for interchangeable is very strict: 1. The interchangeable first has to be classified as a biosimilar. 2. The biosimilar must be expected to produce the same clinical results as the original-biologic product in any given patient. 3. The risk in terms of safety and efficacy of alternating or switching between the use of an interchangeable and the original biologic is not greater than the risk of continued use of just the original biologic product. 2:02:45 PM She noted health-care provider groups that announced their support as follows: · Every state medical society, · The American College of Rheumatology, · The National Medical Association, · The American Association of Clinical Endocrinologists, · The American Association of Neurological Surgeons, · The American College of Mohs Surgery, · Association of Black Cardiologists, · American Society of Plastic Surgeons, · The Congress of Neurological Surgeons, · The National Hispanic Medical Association. She emphasized that the list consisted of health-care providers, not just patient-advocacy groups. She opined that the groups looked hard at the legislation and the consensus language that was reached seems to be appropriate. She reiterated that maintaining the interchangeable "gold standard" is what's best for Alaskans. 2:04:02 PM CHAIR WILSON asked Senator Hughes to address a $4,500 Department of Commerce, Community and Economic Development fiscal note for the bill. SENATOR HUGHES concurred that the fiscal was a little odd. She remarked that she is not accustomed to departments that ask for funding to write a minor set of regulations. She noted that the fiscal note can be addressed in the Senator Labor and Commerce Committee, the next committee of referral. SENATOR GIESSEL pointed out that the fiscal note analysis was referenced on page 2 of the fiscal note. CHAIR WILSON asked if there were any amendments for SB 32. 2:05:33 PM SENATOR GIESSEL offered Amendment 1: 30-LS0188\J.1 Bruce 2/14/17 AMENDMENT 1 OFFERED IN THE SENATE BY SENATOR GIESSEL TO: SB 32 Page 2, line 17: Delete "equivalent drug product or interchangeable biological  product" Insert "(1) equivalent drug product; or  (2) interchangeable biological product after obtaining  authorization under (c) of this section"    Page 2, line 25, following "shall": Insert ", before dispensing the interchangeable biological product," Page 2, line 26: Delete "biological product" Insert "proposed biological product that may be" Page 2, line 27, following "product": Insert ", and obtain authorization from the prescribing practitioner" Page 2, lines 27 - 29: Delete "The communication must be provided within three business days after dispensing the biological product as follows:" Insert "The communication may be provided as follows:" Page 3, line 10, following "information": Insert "to or obtain authorization from the prescribing practitioner" Page 3, line 19, following "information": Insert "and obtain the authorization" Page 3, lines 21 - 22: Delete ", without the prescriber's expressed authorization," Page 3, line 23, following "(A)": Insert "without the prescriber's expressed authorization," Page 3, line 25, following "(B)": Insert "with the prescriber's authorization," 2:05:40 PM SENATOR VON IMHOF objected for discussion purposes. 2:06:14 PM At ease. 2:06:42 PM CHAIR WILSON called the committee back to order. 2:06:48 PM JANE CONWAY, Staff, Senator Giessel, Alaska State Legislature, Juneau, Alaska, summarized that Amendment 1 requires that communication must be provided and authorization obtained from the prescribing practitioner prior to dispensing the medication, the interchangeable biological product. She explained the changes as follows: Page 2, line 17:  Page 2, line 17: adds "or interchangeable biological product." It also adds "interchangeable biological product after obtaining authorization" under "C" of this section. Page 2, line 25:  Following "shall", insert "before dispensing the interchangeable biological product"; again, just emphasizing that these things shall happen before the dispensing of the product. Page 2, line 26:  Deletes the words "biological product" and inserts "proposed biological product that may be" dispensed. Page 2, line 27:  Following "product", inserts the words "and obtain authorization from the prescribing practitioner". Page 2, lines 27-29:  Deletes the line, "The communication must be provided within three business days after dispensing the biological product as follows:", that whole line is deleted and inserted instead is, "The communication may be provided as follows:", and then it goes on to show how those different communications can be done. Page 3, line 10:  Following "information", inserts the words, "to or obtain authorization from the prescribing practitioner". Page 3, line 19:  Following "information", inserts the words, "and obtain the authorization". Page 3, lines 21-22:  An error to a comma that was caught during the draft of the amendment, delete "',' without the prescriber's expressed authorization". Page 3, line 23:  Following "(A)" inserts, "without the prescriber's expressed authorization". Page 3, line 25:  Following "(B)" inserts, "with the prescriber's authorization". All of these changes have to do with the intent of that amendment to have all of the communication be provided and authorized before the dispensing of the drug. 2:10:32 PM SENATOR GIESSEL spoke to Amendment 1 as follows: We held public testimony on this bill last week. My concern is that the testimony was solely from those individuals who advocates for the bill. Oral history last week had 7-national organizations advocating for this bill and 4-local organizations, there was no oppositional testimony. In the letters, written documents, we have 16-national organizations advocating and 1-local organization, and 2-local folks are opposing this; those local folks were never heard from, so I'm actually speaking on behalf of them, I'm actually told that one of those local individuals who wrote a letter was asked to withdraw her letter, that concerns me. The argument that's put forth in the most recent document I received today, in fact an hour or so, came from the Arthritis Foundation and I've heard this argument before that such an amendment that I'm offering would conflict with federal law, because the federal law allows this without the substitution, without intervention of the health-care provider, and this is asserted to be a reason that the state of Alaska cannot be more strict and I'm no lawyer, but I contested that assertion. I believe state law can be more restrictive than federal law, so I don't believe that negates the amendment. I'm a clinician, it has been asserted that if the FDA approves this, it's got to be okay. I have heard from specialists who use these medications that these are unique proteins that act uniquely in each one of us in a different way and that switching from one protein to the other, in other words these allegedly interchangeable products actually diminishes the effectiveness of these unique proteins in the individual's body, that concerns me. The second thing that concerns me is FDA approval being asserted as a "gold standard." About 15 years ago, the Varivax vaccine was approved by the FDA, this is a vaccination for children to prevent the occurrence of chicken pox. I worked at a pediatric clinic at that time and we gave one of the first Varivax vaccines in this state; a week later that two- year old came in and could no longer walk, his verbal skills were significantly impaired, and he was having a reaction to this Varivax vaccine. FDA does not mean that there will not be adverse events; that sticks in my mind as the question I always put behind someone who says, "FDA approves it, it must be okay." I also question, and I have heard from a pharmacist that they are not sure they have a concern about this, but I have concerns for the pharmacist's liability. So the pharmacist is now making a decision to change this very unique protein medication without discussion with the clinician, change it to a different formulation. So the clinician has the health records of this individual, the clinician knows a lot about the patient and he has chosen, he or she, has chosen this unique protein medication, wonderful medications, and now the pharmacist is unilaterally going to change that without consultation with the clinician. I contend that there's going to be a liability for that pharmacist if there's an adverse outcome; that of course can only be tested in a court of law, that's a very expensive process. So that's my reason for offering this amendment. I don't believe this has to be rushed, I don't believe this needs to be done without the team that makes up health care: the clinician, the pharmacist, and the patient, all consulting together for the best outcomes. 2:15:27 PM CHAIR WILSON asked if there was further objection to the amendment. SENATOR BEGICH announced that he objected to Amendment 1. He explained his objection as follows: As Senator Giessel duly noted in a duly noticed public hearing that all of the proper, appropriate notice required by law, a number of organizations testified on this bill and anyone was able and had opportunity to testify on this bill. We had testimony, as she points out, that was overwhelmingly in favor of this legislation. I also take note of some of the comments from the Arthritis Foundation, which I also received today and would note that there's a question here of the amendment proposed potentially delaying prescription service, but I want to go further and since we are talking about personal stories, a member of my own staff is a beneficiary of these products. My staffer who is in the audience, Richard Benavides, suffers from cancer, uses these and has identified to me that the ability to have rapid access to what are known to be safe procedures is something that he finds is essential to his wellbeing. I would argue that our duty here is to allow a public process and then through that public process, adjust if necessary a bill. We have done that public process, the testimony overwhelmingly favored the bill as is or in fact moves in the opposite direction of what Senator Giessel is proposing. We will have further committees and there will be further opportunity, but at this time I just want to express my objection to that amendment and would urge the members to not support this amendment. 2:17:56 PM SENATOR GIESSEL clarified that public testimony did not allow opposition. She set forth that the individuals who opposed the bill were online and were not allowed to testify because the meeting ran out and public testimony was closed; consequently, their voice was not heard. She explained that Amendment 1 does not limit access to biologics in any way. She specified that the interchangeables, which are addressed in the bill, are not yet available and may not be available for several years. She asked what the rush is. CHAIR WILSON noted for the record that some of the comments for and against were publicized and made available on the internet for folks to see. SENATOR VON IMHOF commented on Amendment 1 as follows: I very much appreciate the robust dialogue and thank you Senator Giessel, you brought up actually some interesting points that gave me pause today and made me think, it's interesting trying to digest the information that comes in associated with all of these bills, both in the written form and in the verbal form. As we sit here, I feel that it is best to try to, again, to use my words I said in the previous bill, thread-the-needle and try to find the best-foot- forward based on the information that we have in front of us. I understand the concern with the FDA, I don't share those same concerns; I believe that it is a very robust and successful entity and that their analysis gives me comfort. I also see in the letter we received today that biosimilars have been used in Europe with excellent safety and efficacy profile since 2006, and have resulted in significant cost savings. Health-care costs in Alaska is a significant issue as we can all attest and if there's no clinical, meaningful differences between biologic and the reference biological in terms of safety, purity and potency, yet it provides a cost difference, then I think it makes sense to go forward with this. I understand that there are no biosimilars on the market now, but yes it could be years from now, or it could be months from now, we don't know. So as a good boy scout it's best to be prepared. I'm going to vote for the pure form of this bill and not support the amendment. 2:21:40 PM A roll call vote was taken. Senator Giessel and Chair Wilson voted in favor of Amendment 1; Senators Begich and von Imhof voted against it. Therefore, Amendment 1 failed by a 2:2 vote. CHAIR WILSON announced that hearing no further amendments, he would entertain a motion to move SB 32 out of committee. 2:21:53 PM SENATOR VON IMHOF moved to report SB 32, [30-LD0188\J], from committee with individual recommendations and attached fiscal note(s) 2:22:03 PM CHAIR WILSON announced that without objection, SB 32 moved from Senate Health and Social Services Standing Committee. 2:22:12 PM SENATOR GIESSEL commented as follows: Before we leave this subject, you know there's a reason that Senator von Imhof is on the finance committee. She has expertise in that area. There's a reason that I am on the health committee. I'm a clinician. I appreciate the discussion today, thank you.