Legislature(2015 - 2016)SENATE FINANCE 532

04/11/2016 09:00 AM FINANCE

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* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+= SB 101 STATE PARKS FEES & SALES OF MERCHANDISE TELECONFERENCED
Moved CSSB 101(FIN) Out of Committee
+= SB 200 MANDATORY PHYSICAL ACTIVITY IN SCHOOLS TELECONFERENCED
Scheduled but Not Heard
+= SB 201 PHARMA BD & EMPLOYEES;DRUG DIST/MANUFAC TELECONFERENCED
Moved SB 201 Out of Committee
+= SJR 12 CONST. AM: ELECTED ATTORNEY GENERAL TELECONFERENCED
Moved SJR 12 Out of Committee
+= SB 196 POWER COST EQ FUND: RESERVE ACCT;DIVIDEND TELECONFERENCED
Moved CSSB 196(FIN) Out of Committee
+= SB 210 COMM. REV. SHARING;PROP. TAX EXEMPTIONS TELECONFERENCED
Heard & Held
+ Bills Previously Heard/Scheduled TELECONFERENCED
SENATE BILL NO. 201                                                                                                           
                                                                                                                                
     "An Act relating to the  Board of Pharmacy; relating to                                                                    
     the  licensing  and  inspection of  certain  facilities                                                                    
     located  outside the  state;  relating  to drug  supply                                                                    
     chain security;  and creating  a position  of executive                                                                    
     administrator for the Board of Pharmacy."                                                                                  
                                                                                                                                
9:29:03 AM                                                                                                                    
                                                                                                                                
Co-Chair  MacKinnon  referred  to a  document  from  Senator                                                                    
Cathy Giessel dated April 9,  2016, in response to questions                                                                    
from the committee (copy on file).                                                                                              
                                                                                                                                
JANE  CONWAY, STAFF,  SENATOR CATHY  GIESSEL, addressed  the                                                                    
document that  answered the  questions that  had come  up at                                                                    
the previous hearing of the bill:                                                                                               
                                                                                                                                
     1. Would  SB 201  apply to regulation  of international                                                                    
     wholesalers? (sub  question.....do our AK  licensees do                                                                    
     business  with  wholesalers  in  Mexico  or  Canada  or                                                                    
     similar?) But even so, we  can't regulate a business in                                                                    
     another country could we?                                                                                                  
                                                                                                                                
     Alaskan pharmacies do not  do business with wholesalers                                                                    
     in Mexico  or Canada  since they presumably  don't sell                                                                    
     US  FDA approved  drugs and  as such  the FDA  does not                                                                    
     allow import of said drugs.                                                                                                
                                                                                                                                
Ms.  Conway specified  that drugs  must be  licensed in  the                                                                    
United States and  be approved by the  United States Federal                                                                    
Drug Administration (FDA).                                                                                                      
                                                                                                                                
Co-Chair MacKinnon  restated that  her question had  been if                                                                    
an international  or foreign  country could  market directly                                                                    
to Alaskans, and somehow bypass the FDA.                                                                                        
                                                                                                                                
Co-Chair  MacKinnon  referred  to the  first  question,  and                                                                    
asked for professional feedback on the matter.                                                                                  
                                                                                                                                
DIRK WHITE, PHARMACIST,  SITKA (via teleconference), relayed                                                                    
that  he recently  finished  his term  as  president of  the                                                                    
Board  of  Pharmacy.  He  stated   there  had  been  ongoing                                                                    
conversation  regarding importation  of  drugs from  foreign                                                                    
countries.  He  recounted  that  in  the  Clinton  era,  the                                                                    
importation of  pharmaceuticals was going to  be allowed but                                                                    
was  later  quashed  by  the  U.S.  Justice  Department.  He                                                                    
discussed  the   Drug  Quality  Security  Act   (DQSA),  and                                                                    
informed  that  there  was  a  practice  called  "track  and                                                                    
trace,"  under  which pharmacists  were  ensured  as to  the                                                                    
provenance and pedigree of the  items that had been ordered.                                                                    
He noted that  he received an electronic file  every time he                                                                    
placed  an order  from a  wholesaler, which  would show  the                                                                    
pedigree  of  each  item  that  was  ordered.  He  discussed                                                                    
prevention efforts by  the Board of Pharmacy  to ensure that                                                                    
wholesalers were following DQSA  regulations. He pointed out                                                                    
that  the  board  had  no  jurisdiction  over  international                                                                    
pharmacies  or  wholesalers,  and   added  that  there  were                                                                    
loopholes.                                                                                                                      
                                                                                                                                
9:34:01 AM                                                                                                                    
                                                                                                                                
Co-Chair MacKinnon  was unclear  as to Mr.  White's response                                                                    
on the matter of  directly accepting drugs from wholesalers.                                                                    
She  wondered if  the bill  should endeavor  to prevent  the                                                                    
ability to  purchase drugs from  a wholesaler  that marketed                                                                    
internationally. She wondered if  the committee should amend                                                                    
the bill to ban the ability to purchase internationally.                                                                        
                                                                                                                                
Mr. White  clarified that the prohibition  she described was                                                                    
essentially  what  pharmacists  had  been  operating  under.                                                                    
According to regulations, he should  not be able to purchase                                                                    
from  an international  pharmacy or  wholesaler, but  he was                                                                    
sure there  was a way around  the rule, which is  why he had                                                                    
mentioned  a loophole.  He referred  to  copious amounts  of                                                                    
packages  that  were  being  sent from  out  of  state,  and                                                                    
thought the FDA was unable  to inspect them all. He asserted                                                                    
that   he  would   always  order   from  a   major  national                                                                    
wholesaler. There were also  small regional businesses which                                                                    
were licensed and certified and  inspected, and were able to                                                                    
ship  into   other  states.   He  did   not  see   that  the                                                                    
international concern was a priority.                                                                                           
                                                                                                                                
Ms. Conway spoke to the  regulation of internet sales on the                                                                    
first page of the document:                                                                                                     
                                                                                                                                
     2. Are internet sales regulated? Sub question - would                                                                      
     AK licensees purchase off the internet? Are they even                                                                      
     allowed to do that?                                                                                                        
                                                                                                                                
     Alaskan Pharmacies may purchase off the internet from                                                                      
     Wholesalers licensed in the  United States and purchase                                                                    
     FDA   approved  drugs.   Alaskan  pharmacies   may  not                                                                    
     purchase  and  then  dispense  drugs  from  wholesalers                                                                    
     (presumably  out  of  the country)  that  are  NOT  FDA                                                                    
     approved.                                                                                                                  
                                                                                                                                
Ms.   Conway   stated   that  individuals   could   purchase                                                                    
medications  over the  internet.  She noted  that there  had                                                                    
been  discussion about  an internet  corporation forming  to                                                                    
address  the dot-com  pharmacy industry;  so  that a  person                                                                    
could  look  up  an  internet  pharmacy to  see  if  it  was                                                                    
certified as handling FDA-approved drugs.                                                                                       
                                                                                                                                
Co-Chair MacKinnon related that  the committee had addressed                                                                    
the  fiscal note  on April  9, 2016.  She noted  that public                                                                    
testimony had opened and closed on the same date.                                                                               
                                                                                                                                
Vice-Chair Micciche MOVED to report  SB 201 out of Committee                                                                    
with individual recommendations  and the accompanying fiscal                                                                    
note.                                                                                                                           
                                                                                                                                
SB   201   was   REPORTED   out  of   committee   with   "no                                                                    
recommendation"  and with  one  previously published  fiscal                                                                    
note: FN1 (CED).                                                                                                                
                                                                                                                                
9:38:36 AM                                                                                                                    
AT EASE                                                                                                                         
                                                                                                                                
9:42:06 AM                                                                                                                    
RECONVENED                                                                                                                      
                                                                                                                                

Document Name Date/Time Subjects
SB 200 Public Testimony Nees.pdf SFIN 4/11/2016 9:00:00 AM
SB 200
SB 200 NEA Alaska Letter.pdf SFIN 4/11/2016 9:00:00 AM
SB 200
SB 210 Community Revenue Sharing Estimates.pdf SFIN 4/11/2016 9:00:00 AM
SB 210
SB 201 Responses to questions during SB 201 hearing SFIN 4.pdf SFIN 4/11/2016 9:00:00 AM
SB 201
SB 210 with $38.2 million vs Status Quo with $60 million.pdf SFIN 4/11/2016 9:00:00 AM
SB 210