03/08/2000 02:40 PM Senate HES

          SB 261-PROTECTION FROM NEEDLE & SHARPS INJURIES                                                                   
                                                                                                                                
CHAIRMAN MILLER announced  that today's meeting was postponed due to                                                            
a  lengthy   Senate  floor  session   and  he  apologized   for  the                                                            
inconvenience.    He  noted  his intention  to  hear  the  sponsor's                                                            
statement  today and to take  testimony from  a person who  traveled                                                            
from out-of-state  to testify.  He  announced that the bill  will be                                                            
heard again on March 21  and asked anyone else wishing to testify on                                                            
the bill to participate in that meeting.                                                                                        
                                                                                                                                
SENATOR  KIM  ELTON, District  B,  gave  the  following abbreviated                                                             
sponsor statement.   SB 261 provides  for a safer needle  and sharps                                                            
instrument  regime in health care  facilities.  Similar legislation                                                             
has been  addressed by  five states  and has been  introduced  in 20                                                            
other states.   He worked closely with health care  providers to try                                                            
to develop  a  workable law.   He  indicated a  proposed  amendment,                                                            
which  he will  ask members  to support  at the  next meeting,  that                                                            
allows some  leeway for  pre-filled needle  manufacturers to  ensure                                                            
that SB 261 works for them also.                                                                                                
                                                                                                                                
MR.   JAKE  MATER,   Government   Affairs   Director   for   Aventis                                                            
Pharmaceuticals,   said  he  was speaking   for  Aventis  and  other                                                            
manufacturers  who have sent written  letters to committee  members.                                                            
Manufacturers  of pre-filled syringes  are concerned that  under the                                                            
current laws in other states,  pre-filled syringes are not currently                                                            
engineered with sharps  devices.  Manufacturers will have to conduct                                                            
stability studies for approximately  two years and then wait for six                                                            
months  to one  year for  FDA approval.   Manufacturers  have  asked                                                            
other  states to  give them  an exemption  to allow  for either  FDA                                                            
approval  or some  timeframe  that  will allow  the  free market  to                                                            
decide  what products  should be made  available  to patients.   The                                                            
manufacturers  support the concept of SB 261 and the  need for these                                                            
devices.  Their primary  concern is for patient and physician access                                                            
to needle products.                                                                                                             
                                                                                                                                
SENATOR ELTON  pointed out that the proposed amendment  provides for                                                            
a three-year period for  manufacturers of pre-filled syringe devices                                                            
to comply.  He  said he does not think any committee  member will be                                                            
unwilling to make additional adjustments if "hiccups" occur.                                                                    
                                                                                                                                
MR. MATER explained that  one of the manufacturers' concerns is that                                                            
as  more  and  more  consolidation  occurs  in  the  pharmaceutical                                                             
industry, products are  being brought in from abroad.  Because those                                                            
products have  not gone through the  entire FDA process,  SB 261 may                                                            
limit product  access to individuals.   He wanted to encourage  some                                                            
forethought  as  far as  the  timeframe for  getting  FDA  approval,                                                            
rather than include a specific date.                                                                                            
                                                                                                                                
CHAIRMAN  MILLER repeated  his intent  to hear SB  261 as the  first                                                            
item of  business before  the committee on  March 20. The  committee                                                            
will  take testimony,  discuss  proposed amendments,  and  hopefully                                                            
move  the bill  on  to its  next committee  of  referral.   He  then                                                            
adjourned the meeting at 2:48 p.m.