BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                    AB 1668


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          ASSEMBLY THIRD READING


          AB  
          1668 (Calderon)


          As Amended  March 7, 2016


          Majority vote


           ------------------------------------------------------------------ 
          |Committee       |Votes|Ayes                  |Noes                |
          |                |     |                      |                    |
          |                |     |                      |                    |
          |                |     |                      |                    |
          |----------------+-----+----------------------+--------------------|
          |Health          |18-0 |Wood, Maienschein,    |                    |
          |                |     |Bonilla, Burke,       |                    |
          |                |     |Campos, Dababneh,     |                    |
          |                |     |Cooley, Roger         |                    |
          |                |     |Hernández, Lackey,    |                    |
          |                |     |Nazarian, Olsen,      |                    |
          |                |     |Patterson,            |                    |
          |                |     |Ridley-Thomas,        |                    |
          |                |     |Rodriguez, Santiago,  |                    |
          |                |     |Steinorth, Thurmond,  |                    |
          |                |     |Waldron               |                    |
          |                |     |                      |                    |
          |----------------+-----+----------------------+--------------------|
          |Business &      |14-0 |Salas, Brough, Baker, |                    |
          |Professions     |     |Bloom, Campos,        |                    |
          |                |     |Chávez, Dahle, Dodd,  |                    |
          |                |     |Burke, Gatto, Jones,  |                    |
          |                |     |Mullin, Ting, Wood    |                    |
          |                |     |                      |                    |
          |----------------+-----+----------------------+--------------------|








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          |Appropriations  |20-0 |Gonzalez, Bigelow,    |                    |
          |                |     |Bloom, Bonilla,       |                    |
          |                |     |Bonta, Calderon,      |                    |
          |                |     |Chang, Daly, Eggman,  |                    |
          |                |     |Gallagher, Eduardo    |                    |
          |                |     |Garcia, Roger         |                    |
          |                |     |Hernández, Holden,    |                    |
          |                |     |Jones, Obernolte,     |                    |
          |                |     |Quirk, Santiago,      |                    |
          |                |     |Wagner, Weber, Wood   |                    |
          |                |     |                      |                    |
          |                |     |                      |                    |
           ------------------------------------------------------------------ 


          SUMMARY:  Authorizes the manufacturer of an investigational  
          drug, biological product, or device (investigational drug) that  
          is not yet approved by the United States Food and Drug  
          Administration (FDA) to make the investigational drug available  
          to a patient with a serious or immediately life-threatening  
          disease, when that patient has considered all other treatment  
          options currently approved by the FDA, has been unable to  
          participate in a relevant clinical trial, and for whom the  
          investigational drug has been recommended by the patient's  
          primary physician and a consulting physician.  Specifies other  
          criteria and parameters for the use of such investigational  
          drugs in this way.


          FISCAL EFFECT:  According to the Assembly Appropriations  
          Committee:


          1)Minor and absorbable costs to the California Department of  
            Health Services (DPH), the Medical Board of California, and  
            Osteopathic Medical Board of California to receive and review  
            biannually reports from institutional review boards on the  
            requests for treatment with an investigational product  
            (various funds).








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          2)Costs of $380,000 in the first year of implementation, and  
            $200,000 ongoing to Department of Managed Health Care (DMHC)  
            (Managed Care Fund).  First year costs are higher because of  
            probable additional legal analysis and processing Public  
            Records Act (PRA) requests for experimental procedures  
            previously authorized or rejected by health plans.  Ongoing  
            costs are related to patient and provider inquiries to the  
            DMHC's Help Center.  DMHC indicates any of the investigational  
            and/or experimental Independent Medical Review (IMR) requests  
            require thorough analysis to determine if literature and  
            studies on the treatments are available, and to review  
            clinical trials, if completed or available. 


          3)The California Department of Insurance may, similarly to DMHC,  
            experience unknown costs related to IMR requests, PRA  
            requests, or other requests for other assistance to the extent  
            these requests increase.  (Insurance Fund).  


          COMMENTS:  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 could  
          be their last hope for survival.  The author further states that  
          those patients that have exhausted all other treatment options,  
          and are not eligible for clinical trials, often seek access to  
          investigational new drugs but face a variety of hurdles.  These  
          patients may seek compassionate use exemptions from the FDA, but  
          the process is cumbersome and approval comes too late for many.   
          The author explains this bill removes barriers for patients who  
          need to immediately obtain investigational treatments, while  
          also protecting physicians, hospitals, and manufacturers from  
          retribution.


          Patient requests for access to drugs and biologics prior to  
          their approval have long created a dilemma for regulators, who  
          must balance the needs of patients and their families who  
          believe that an experimental product could save their life, with  








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          ensuring the safety of the greater population through tightly  
          controlled clinical trials and drug approval.  This issue has  
          become increasingly visible and difficult in recent times, as  
          views about the inherent right of patients in certain situations  
          to unapproved products have been expressed by patients and their  
          advocates, state legislators, members of Congress, and some  
          court cases.  In 2014 four states adopted legislation similar to  
          this bill (Colorado, Louisiana, Michigan, and Missouri) and one  
          state (Arizona) adopted a resolution to place the issue on the  
          November 2014 ballot, where it was approved by voters.   
          According to the National Conference on State Legislatures, at  
          least 41 other states considered similar right-to-try  
          legislation in 2015.  


          Supporters argue that patients with no other treatment options  
          should be able to take on more risk than healthy patients would  
          otherwise choose.  The Los Angeles County Board of Supervisors  
          supports this bill, stating that terminally ill patients, who  
          have exhausted their options to find a cure and who have  
          identified a physician and pharmaceutical company willing to  
          assist them, deserve the right to experimental treatments that  
          could prolong their lives. 


          The Medical Oncology Association of Southern California (MOASC)  
          opposes, stating that "while we appreciate the interest in  
          supporting patients, there are substantive dangers in a "right  
          to try" outside the context of a clinical trial, including the  
          damage to adult clinical trial enrollment, which hold the  
          promise of the future of medicine." MOASC additionally raises  
          concerns about the difficulty identifying an "immediately  
          life-threatening condition", the lack of sufficient informed  
          consent process to protect patients seeking these drugs, and the  
          lack of appropriate physician supervision of the use of these  
          drugs.  The California Nurses Association (CNA) states that this  
          bill erroneously suggests that consumers do not have access to  
          these drugs because physicians fear their liability to practice  
          medicine would be compromised and their liability increased if  








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          they were to recommend such treatment.  CNA points out that  
          nothing in this legislation impacts the availability of drugs to  
          terminally ill patients unless the manufacturer of a drug allows  
          it to be used in advance of FDA approval.




          Analysis Prepared by:                                             
                          John Gilman / HEALTH / (916) 319-2097  FN:  
          0003206