Legislature(1997 - 1998)

04/02/1997 03:23 PM House L&C

Audio Topic
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
txt
 HJR 31 - FEDERAL FOOD, DRUG, AND COSMETIC ACT                                 
                                                                               
 Number 030                                                                    
                                                                               
 CHAIRMAN ROKEBERG announced the first order of business would be              
 HJR 31, "Requesting the United States Congress to amend the Federal           
 Food, Drug, and Cosmetic Act," sponsored by Representative Pete               
 Kott                                                                          
                                                                               
 Number 086                                                                    
                                                                               
 NICOLE POIRRIER, Intern to Representative Pete Kott, Alaska State             
 Legislature, came before the committee to address HJR 31.  She said           
 the resolution asks Congress to take a look at the Federal Food,              
 Drug and Cosmetic Act.  Currently, there are several products that            
 are in the testing phase that could be more rapidly approved to               
 assist patients suffering from various illnesses.  She said HJR 31            
 asks Congress to speed up that process.                                       
                                                                               
 Number 149                                                                    
                                                                               
 REPRESENTATIVE TOM BRICE asked Ms. Poirrier if she has specific               
 recommendations of the Food and Drug Administration (FDA) about how           
 they could speed up that process.                                             
                                                                               
 REPRESENTATIVE PETE KOTT, sponsor of HJR 31, responded, "In                   
 specific, there are no general areas that we're specifically                  
 looking at.  In generalities, that whole U.S. code is a fairly                
 extensive session.  We actually ran off a copy, but not to bore you           
 with the details, we tried to peruse it as much as possible and               
 tried to glean from what steps are involved and it's a nightmarish            
 code that's really difficult to understand to begin with."                    
 Representative Kott said it is his understanding that Congress                
 currently has two measures, one in the House and one in the Senate,           
 that analyzes the code for those red tape areas that could expedite           
 products coming to market much more sooner than they currently are.           
 He pointed out many of the products are in the testing stage and              
 could take three to eight years to be released.  He said an example           
 is AZT, which treats AIDS (acquired immune deficiency syndrome),              
 was in the experimental stage for about four and a half to five               
 years.  He said he thinks that those people who suffered from the             
 virus would have liked to have taken their chances early on versus            
 not having anything for treatment.  Representative Kott said the              
 resolution asks Congress to look at that area in the code and                 
 determine what areas need to be changed that could potentially                
 expedite these products coming to market.                                     
                                                                               
 Number 307                                                                    
                                                                               
 REPRESENTATIVE JOE RYAN said Representative Kott talked about                 
 dissemination of information.  He asked him if he knows if Congress           
 has any plans in "ringing" in these people a little bit.  He said             
 he has noticed that lately they prohibit anybody from saying                  
 (indisc.) to say what benefits may be derived from using a certain            
 vitamin and yet, physicians will give you certain vitamins during             
 pregnancy to make sure certain diseases don't happen because it               
 could be from a vitamin deficiency that causes these diseases.  Yet           
 the FDA won't allow anybody to put on a vitamin label any                     
 information as to what the use of vitamins will do to help you.               
 They shut down people's ability to make statements that are proven            
 scientific facts.                                                             
                                                                               
 REPRESENTATIVE KOTT said he isn't aware of any of the specifics               
 that Representative Ryan is addressing.  He pointed out many of the           
 products that are currently being dispensed are dispensed for a               
 certain ailment that a product has been approved to be dispensed              
 for.  He said, "What I am of the understanding is that we're also             
 asking, through the Congressional legislation, is for those                   
 products that are currently approved to at least provide                      
 additional, and this is the pharmaceuticals, provide information to           
 those physicians for some of the ailments that the product is not             
 approved for that could lead to them at least assisting in the                
 discussion and dialogue with patients perhaps offering additional             
 options."  He said the whole process is basically one that's a very           
 difficult one and there is a lot of red tape and hurdles to jump              
 through.  He noted he thinks we have come a long ways from the                
 initial writing of the code and it's time to revisit it.  He said             
 maybe there needs to be a preapproval stage for those cases that              
 are terminal.                                                                 
                                                                               
 Number 528                                                                    
                                                                               
 CHAIRMAN ROKEBERG said he noticed in his committee file that there            
 is a page of information referencing the activities of the 104th              
 Congress and specific references to SB 1477 and HR 3199.  He asked            
 if those are Senate joint and the House resolutions regarding this            
 activity.                                                                     
                                                                               
 REPRESENTATIVE KOTT said that is correct.                                     
                                                                               
 CHAIRMAN ROKEBERG asked where those currently are in the realm of             
 things.                                                                       
                                                                               
 REPRESENTATIVE KOTT said they're moving through the process at a              
 relatively stable and slow rate as most Congressional actions move.           
 He said HJR 31 asks Congress to continue moving that legislation              
 through the process.  He said he is not asking that public safety             
 be jeopardized in any shape of fashion.  It asks them to look at              
 the procedures involved to see if we can maintain public safety as            
 well as to move those products to market.                                     
                                                                               
 CHAIRMAN ROKEBERG said HJR 31 is intended to spur along the passage           
 of those particular Congressional actions.                                    
                                                                               
 REPRESENTATIVE KOTT said that is correct.                                     
                                                                               
 CHAIRMAN ROKEBERG asked if the Pharmaceutical Association is                  
 interested in this activity.                                                  
                                                                               
 REPRESENTATIVE KOTT indicated they are supportive.                            
                                                                               
 Number 632                                                                    
                                                                               
 REPRESENTATIVE BILL HUDSON asked if this is something that is                 
 moving through the National Conference of State Legislatures (NCSL)           
 where there is a broad base of states that are appealing for this             
 kind of legislation.                                                          
                                                                               
 REPRESENTATIVE KOTT said he isn't sure if it is supported by the              
 NCSL, but said he wouldn't be surprised if it is because they are             
 generally in support of this kind of legislation.  He noted there             
 are 20 plus states that have submitted resolutions of similar                 
 nature.                                                                       
                                                                               
 Number 711                                                                    
                                                                               
 REPRESENTATIVE JOHN COWDERY made a motion to move HJR 31 out of               
 committee with individual recommendations.                                    
                                                                               
 CHAIRMAN ROKEBERG asked if there was an objection.  Hearing none,             
 HJR 31 moved out of the House Labor and Commerce Standing                     
 Committee.                                                                    
                                                                               

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