Legislature(2017 - 2018)BUTROVICH 205

02/15/2017 01:30 PM HEALTH & SOCIAL SERVICES

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* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
Moved SB 36 Out of Committee
-- Testimony <Invitation Only> --
+ Bills Previously Heard/Scheduled: TELECONFERENCED
Moved SB 32 Out of Committee
          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                                                               
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                                                               
SENATOR   HUGHES    detailed   that   the   FDA    criteria   for                                                               
interchangeable is very strict:                                                                                                 
   1. The interchangeable first has to be classified as a                                                                       
   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:                                                                                            
                          AMENDMENT 1                                                                                       
OFFERED IN THE SENATE                   BY SENATOR GIESSEL                                                                      
TO:  SB 32                                                                                                                      
Page 2, line 17:                                                                                                                
Delete  "equivalent drug  product  or interchangeable  biological                                                           
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                                                               
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                                                               
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                                                                         
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                                                                    
     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                                                                    
     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                                                                    
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                                                                    
2:15:27 PM                                                                                                                    
CHAIR WILSON asked if there was further objection to the                                                                        
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                                                                    
     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                                                                    
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                                                                   
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                                                                       

Document Name Date/Time Subjects
ASPS Comments - Scope Optometric - AK SB36 - 02-13-2017.pdf SHSS 2/15/2017 1:30:00 PM
SB 36
Carmen Moore - oppose.pdf SHSS 2/15/2017 1:30:00 PM
SB 36
Drug schedules - Giessel.pdf SHSS 2/15/2017 1:30:00 PM
SB 36
New Mexico House Business & Industry Committee Letter 2007.pdf SHSS 2/15/2017 1:30:00 PM
SB 36
SB 32 Legislation - Version J.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/10/2017 1:30:00 PM
SHSS 2/15/2017 1:30:00 PM
SB 32
SB 36 ASMA oppose.pdf SHSS 2/15/2017 1:30:00 PM
SB 36
Alaska Biosimilars Arth Fdn oppose amendment sb 32.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/15/2017 1:30:00 PM
SB 32
SB32 - Clarification on Questions Asked in the Committee (Sen Hughes).doc HHSS 4/13/2017 3:00:00 PM
SHSS 2/15/2017 1:30:00 PM
SB 32
SB32_ASMA.pdf HHSS 4/13/2017 3:00:00 PM
SHSS 2/15/2017 1:30:00 PM
SB 32
SB 32 Am No. 1.PDF SHSS 2/15/2017 1:30:00 PM
SB 32