BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  AB 1727
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          ASSEMBLY THIRD READING
          AB 1727 (Rodriguez) 
          As Amended May 15, 2014
          Majority vote 

           HEALTH              19-0                                        
           
           -------------------------------- 
          |Ayes:|Pan, Maienschein,         |
          |     |Ammiano, Gordon, Bonilla, |
          |     |Bonta, Chávez, Chesbro,   |
          |     |Gomez, Gonzalez,          |
          |     |Roger Hernández,          |
          |     |Lowenthal, Waldron,       |
          |     |Nazarian, Nestande,       |
          |     |Patterson, Ridley-Thomas, |
          |     |Wagner, Wieckowski        |
          |     |                          |
           -------------------------------- 
           SUMMARY  :  Prohibits the redistribution of any prescription drug  
          that the federal Food and Drug Administration (FDA) through Risk  
          Evaluation and Mitigation Strategies (REMS) requires be  
          dispensed only to patients registered with the drug's  
          manufacturer.

           FISCAL EFFECT  :  None

           COMMENTS  :  According to the author, this bill is needed to  
          strengthen patient protections and ensure patients that are  
          using drugs with serious side effects have access to the  
          required monitoring procedures.  The author notes existing law  
          governing county surplus drug collection and distribution  
          programs does not prohibit medications which are mandated by the  
          FDA to have a REMS from being donated to and dispensed from drug  
          repository programs.  REMS programs imposed by the FDA require  
          pharmaceutical manufactures to track prescriptions from the  
          doctor, through the pharmacy, and to the patient in order to  
          minimize serious side effects.  The author argues allowing  
          pharmacies that participate in a repository program to receive  
          and re-distribute these types of drugs undermines the safety  
          precautions established by REMS programs. 

          Counties that adopt an ordinance to establish a voluntary drug  
          repository and distribution program in California must also  
          establish eligibility for medically indigent patients who may  








                                                                  AB 1727
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          participate in the program free of charge; develop a formulary  
          of appropriate medications for the program; provide for the  
          proper safety and management of any medications collected by and  
          maintained under the authority of a participating licensed  
          pharmacy; and, protect the privacy of individuals for whom the  
          medication was originally prescribed.  Controlled substances,  
          i.e., prescription drugs with the potential for abuse, and  
          medication in the possession of a patient or any individual  
          member of the public are not eligible for donation.  

          Drugs that are dispensed under the program are required to be in  
          a new and properly labeled container that is specific to the  
          eligible patient.  In addition, donated drugs are required to be  
          physically separated from the participating pharmacy's other  
          drug stock for purposes of inventory, accounting, and  
          inspections.  Pharmacies must also keep complete records of the  
          acquisition and disposition of medication donated to and  
          dispensed under the program.  Lastly, a participating pharmacy  
          is required to follow the same procedural drug pedigree  
          instructions for donated drugs as it would follow for drugs  
          purchased from a wholesaler or directly from a manufacturer.   
          Only Santa Clara County has established a voluntary drug  
          repository and distribution program.  

          The Food and Drug Administration Amendments Act of 2007 gave the  
          FDA the authority to require a REMS from pharmaceutical  
          manufacturers to ensure that the benefits of a drug or  
          biological product outweigh its risks.  Many different drugs are  
          on this list, including some that are quite commonly prescribed.
             
           The elements of REMS can vary dramatically.  For AndroGel, a  
          commonly prescribed drug used in testosterone replacement  
          therapy, the very brief REMS requires dispensing a consumer  
          information packet with each prescription.  There is no  
          registration of the patients.  For thalidomide, a drug that once  
          resulted in the death or mutation of 10,000 children worldwide,  
          the requirements are much different.  The FDA approved a  
          179-page REMS with very strict controls, including limiting  
          prescription and dispensing rights only to authorized  
          prescribers and pharmacies, keeping a registry of all patients  
          prescribed thalidomide, providing extensive patient education  
          about the risks associated with the drug, and providing periodic  
          pregnancy tests for women who take the drug.  The program  
          includes physician-patient agreements governing use of  
          contraceptives and contingencies if the patient needs to be  








                                                                  AB 1727
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          tested for pregnancy.  The FDA approved the use of the drug  
          because it has therapeutic value for a number of very serious  
          illnesses and conditions, including many cancers.

          This bill would allow donations to a county voluntary drug  
          repository and distribution program of some of the drugs that  
          are subject to the REMS.  This bill would allow drugs to be  
          donated if not prohibited by the REMS and if the drug is  
          dispensed in accordance with the REMS.  

          Celgene Corporation (Celgene) supports this bill because it will  
          help provide safety to both patients and their families and  
          comply with the strict controlled distribution guidelines for  
          various drugs that require the manufacturers to track each  
          prescription from the doctor, through the pharmacy, to the  
          patient to minimize the risk of fetal exposure.  Celgene notes  
          these risk management programs are an integral part of the FDA  
          approval and are designed to minimize the risk of fetal  
          exposure.  Celgene argues that allowing pharmacies to  
          participate in a repository program to receive and redistribute  
          these types of drugs undermines the safety precautions  
          established by the FDA program.  The Pharmaceutical Research and  
          Manufacturers of America (PhARMA) support this bill because it  
          will protect consumers.  According to PhARMA, concerns about  
          possible fetal exposure renders these medications unsuitable for  
          redistribution.  They note that other states have enacted  
          similar controls over products which must adhere to strict FDA  
          guidelines on distribution.  

          There is no opposition on file.
           

          Analysis Prepared by  :    Roger Dunstan / HEALTH / (916) 319-2097  



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