Legislature(2017 - 2018)ADAMS ROOM 519

04/11/2018 01:30 PM FINANCE

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* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
Scheduled but Not Heard
Moved HCS SB 32(FIN) Out of Committee
-- Public Testimony --
Moved HCS CSSSSB 4(L&C) Out of Committee
-- Public Testimony --
+ Bills Previously Heard/Scheduled TELECONFERENCED
Moved CSHB 306(FIN) Out of Committee
Moved HB 384 Out of Committee
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                                                                    
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                                                                                                                    
Co-Chair  Foster would  be passing  the gavel  to Vice-Chair                                                                    
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                                                                    
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                                                                    
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                                                                                                                    
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                                                                    
4:05:55 PM                                                                                                                    
AT EASE                                                                                                                         
4:06:52 PM                                                                                                                    

Document Name Date/Time Subjects
HB 339 Support.pdf HFIN 4/11/2018 1:30:00 PM
HB 339
SB032 Opposing Document-Opposition Letters 04.17.17.pdf HFIN 4/11/2018 1:30:00 PM
SB 32
SB032 Sectional Analysis ver J 04.17.17.pdf HFIN 4/11/2018 1:30:00 PM
SB 32
SB032 Sponsor Statement 04.17.17.pdf HFIN 4/11/2018 1:30:00 PM
SB 32
SB032 Supporting Documents-Support Letters 04.17.17.pdf HFIN 4/11/2018 1:30:00 PM
SB 32
SB32_Support_050317.pdf HFIN 4/11/2018 1:30:00 PM
SB 32
SB4 Explanation of Changes ver. J to ver. N 4.2.3018.pdf HFIN 4/11/2018 1:30:00 PM
SB 4
SB4 Sectional Analysis ver. N 4.2.2018.pdf HFIN 4/11/2018 1:30:00 PM
SB 4
SB4 Sponsor Statement ver. N 4.2.2018.pdf HFIN 4/11/2018 1:30:00 PM
SB 4
SB4 Support Letters 4.2.2018.pdf HFIN 4/11/2018 1:30:00 PM
SB 4
SB4 Support Doc - News Articles 4.2.2018.pdf HFIN 4/11/2018 1:30:00 PM
SB 4
SB4 Support Doc - Braiding Regs Report Packet Version 4.2.2018.pdf HFIN 4/11/2018 1:30:00 PM
SB 4
SB4 Support Doc - DEC Letters 4.2.2018.pdf HFIN 4/11/2018 1:30:00 PM
SB 4
Board of Pharmacy BOP 3-22-18 SB32 Support Letter.pdf HFIN 4/11/2018 1:30:00 PM
SB 32
HB 386 Opposition.PDF HFIN 4/11/2018 1:30:00 PM
HB 386
Alaska AMCP letter SB 32.pdf HFIN 4/11/2018 1:30:00 PM
SB 32
HB384 2018-03-29 ATA Comments in Opposition to .pdf HFIN 4/11/2018 1:30:00 PM
HB 384
HB 384 Letter of Opposition - House Finance.pdf HFIN 4/11/2018 1:30:00 PM
HB 384
HB 385 - Sectional Analysis - 4.10.2018.pdf HFIN 4/11/2018 1:30:00 PM
HB 385
SB 32 Alaska Biosimilars one-pager.pdf HFIN 4/11/2018 1:30:00 PM
SB 32
SB 32 Alaska UNITED Support doc_4.11.18.pdf HFIN 4/11/2018 1:30:00 PM
SB 32
SB 32 Biologicals list under 505 pathway.pdf HFIN 4/11/2018 1:30:00 PM
SB 32
HB 306 CS WORKDRAFT v J.pdf HFIN 4/11/2018 1:30:00 PM
HB 306