BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                     AB 159


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          Date of Hearing:  May 13, 2015


                        ASSEMBLY COMMITTEE ON APPROPRIATIONS


                                 Jimmy Gomez, Chair


          AB  
          159 (Calderon) - As Amended April 28, 2015


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          |             |Business and Professions       |     |14 - 0       |
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          Urgency:  No  State Mandated Local Program:  NoReimbursable:  No


          SUMMARY:


          This bill sets up a legal structure whereby individuals with  
          serious or immediately life-threatening conditions can gain  
          access to investigational drugs, biological product, or medical  
          devices (investigational products). Specifically, this bill: 








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             1)   Defines investigational drug, biological product, or  
               device as a drug, biological product, or device that has  
               successfully completed phase one of a clinical trial  
               approved by the United States Food and Drug Administration  
               (FDA), but has not been approved for general use and  
               remains under investigation in an approved clinical trial.



             2)   Allows, but does not require, the manufacturer of an  
               investigational product to make the product available to an  
               eligible patient, as defined.  Specifies that the  
               manufacturer require a patient to pay for the costs of the  
               investigational product. 

             3)   Defines an eligible patient as one who has met a number  
               of specified criteria, including having a serious or  
               life-threatening condition, as defined, and having  
               considered all FDA-approved treatment options. 



             4)   Allows, but does not require, a health plan or insurer  
               to provide coverage for the investigational product, or the  
               costs of services related to the use of the investigational  
               product. 



             5)   Prohibits a state regulatory board from taking  
               disciplinary action against a physician's license, and  
               prohibits a state agency from altering a recommendation  
               made to the federal Centers for Medicare and Medicaid  
               Services regarding a health care provider's certification  
               to participate in the Medicare or Medicaid program, based  
               on the recommendation, prescription, or treatment of the  
               investigational product, provided the recommendation or  








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               prescription is consistent with protocol approved by an  
               institutional review board. 



             6)   Prohibits an official, employee, or agent of the state  
               from blocking or attempting to block an eligible patient's  
               access to an investigational product pursuant to this  
               article. 



             7)   Specifies it does not create a private cause of action  
               against a manufacturer of an investigational product, or  
               against any other person or entity involved in the care of  
               an eligible patient using the investigational product, for  
               any harm done to the patient resulting from it, so long as  
               the manufacturer or other person or entity is  complying in  
               good faith with the terms of this article, unless there was  
               a failure to exercise reasonable care.





             8)   Requires institutional review boards to report  
               information about requests for investigational products to  
               the California Department of Public Health (CDPH), the  
               Medical Board of California (MBC), and the Osteopathic  
               Medical Board of California (OBMC).
          FISCAL EFFECT:


          Minor and absorbable costs to CDPH, MBC, and OMBC to receive and  
          review biannually reports from institutional review boards on  
          the requests for treatment with an investigational product. 


          COMMENTS:








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          1)Purpose.  According to the author, this bill removes barriers  
            to accessing potentially life-saving drugs for terminally-ill  
            patients and doctors who believe an investigational drug or  
            device could be their last hope for survival.  These patients  
            may seek compassionate use exemptions from the FDA, but the  
            process is cumbersome and approval comes too late for many.   
            This bill removes barriers for patients who need to  
            immediately obtain investigational treatments, while also  
            protecting physicians, hospitals, and manufacturers from  
            retribution.
          


          2)Background.  Drugs and devices go through clinical trials,  
            stage one of which establishes safety and assesses toxicity.   
            Once a drug or devices passes stage one, there are two more  
            phases before being approved for sale.  This bill would allow  
            manufacturers to make available investigational products, that  
            have passed phase one trials, to patients meeting specified  
            criteria, and would protect from liability doctors who  
            recommend or prescribe the investigational products, as well  
            as manufacturers who make them available.  



            Experimental treatments are often available by participating  
            in a clinical trial.  If a patient is unable to enroll in a  
            clinical trial, the FDA expanded access exemption, also called  
            "compassionate use," provides a pathway for patients to gain  
            access to investigational drugs or devices for serious  
            diseases or conditions.  A licensed physician is able to apply  
            for expanded access on behalf of the patient. The physician  
            must be willing to commit to oversee the treatment, work with  
            the manufacturing company and FDA, obtain the drugs, monitor  
            the patient during the course of treatment, and file necessary  
            paperwork.  The FDA states that they receive approximately  
            1,000 expanded use applications per year, and has approved  








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            more than 99% of those applications.  



          3)Support. The Los Angeles County Board of Supervisors supports  
            this bill. 



          4)Opposition. The California Medical Association, California  
            Nurse Association/National Nurses United, Association of  
            Northern California Oncologists oppose this bill, citing  
            patient safety and other concerns.  The Association of  
            Northern California Oncologists believe this bill threatens  
            the viability of adult clinical trial enrollment and would  
            result in slowing the development of cancer care in the  
            future.
          


          5)Related Legislation.  


            


             a)   SB 149 (Stone), pending in Senate Appropriations  
               Committee, is largely similar to this bill, with  
               differences primarily in definitions and liability  
               exemptions. 



             b)   SB 715 (Anderson) is largely the same as this bill with  
               some differences in definitions. SB 715 was referred to  
               Senate Health Committee and not heard. 











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             c)   SB 128 (Wolk), pending in the Senate Appropriations  
               Committee, permits a competent, qualified individual who is  
               a terminally ill adult to receive a prescription for aid in  
               dying medication if certain conditions are met.  



          Analysis Prepared by:Lisa Murawski / APPR. / (916)  
          319-2081