BILL ANALYSIS                                                                                                                                                                                                    

                                                                     AB 463

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          Date of Hearing:  April 28, 2015 

                            ASSEMBLY COMMITTEE ON HEALTH

                                    Bonta, Chair

                     463 (Chiu) - As Introduced  February 23, 2015

          SUBJECT:  Pharmaceutical Cost Transparency Act of 2015.

          1)Requires that pharmaceutical companies file an annual report  
            with the Office of Statewide Health Planning and Development  
            (OSHPD) regarding the pricing of prescription drugs.   
            Specifically, this bill:  

          1)Requires that a pharmaceutical manufacturer that sells a  
            prescription drug in California file a report with OSHPD if  
            the wholesale acquisition cost (WAC) of the drug is more than  
            $10,000 annually or per course of treatment.  The report must  
            include the following:

             a)   The total cost of production of the drug, including:

               i)     Research and development costs, both to the  
                 manufacturer and any predecessor companies;

               ii)    Clinical trial and regulatory costs, both to the  
                 manufacturer and any predecessor companies;

               iii)   Materials, manufacturing, and administration costs  


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                 of the drug;

               iv)    Costs paid by any other entity, including federal,  
                 state, or other governmental programs or any form of  
                 subsidy, grant or other support; 

               v)     Acquisitions costs of the drug, including patents,  
                 licensing, or acquisition of another corporate entity;  

               vi)    Marketing and advertising costs for the promotion of  
                 the drug. 

             b)   A cumulative annual history of the average wholesale  
               price (AWP) and WAC increases, and which month the  
               increases took effect; 

             c)   Total company profits attributable to the drug; and,

             d)   Total amount of financial assistance the manufacturer  
               has provided through patient prescriptions assistance  
               programs, if available. 

          2)Requires that the information provided in this report be  
            audited by a fully independent third-party auditor prior to  


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          3)Requires that the report be filed with OSHPD annually, on a  
            form prescribed by OSHPD, no later than May 1 of each year. 

          4)Requires OSHPD to issue an annual report to the Legislature  
            outlining the information submitted pursuant to this section,  
            and that OSHPD post the report publicly on its Website. 

          5)Requires OSHPD to convene an advisory workgroup to develop the  
            submission form. Specifies that the workgroup must include, at  
            least, representatives from the pharmaceutical industry,  
            health care service plans and insurers, pharmacy benefit  
            managers, governmental agencies, consumer advocates and  

          EXISTING LAW:  

          1)Establishes OSHPD, and designates OSHPD as the single state  
            agency to collect specified health facility or clinic data for  
            use by all state agencies.

          2)Requires hospitals to make and file with OSHPD certain  
            specified reports, including a Hospital Discharge Abstract  
            Data Record, an Emergency Care Data Record, and an Ambulatory  
            Surgery Data Record..

          3)Requires OSHPD to compile and publish summaries of individual  
            facility and aggregate data that do not contain  
            patient-specific information for the purposes of public  


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          FISCAL EFFECT:  This bill has not been analyzed by a fiscal  


          1)PURPOSE OF THIS  
            BILL.  The author asserts that as prices for both new and  
            existing prescription drugs continue to rise, it is critically  
            important to analyze drug price and underlying costs  
            associated with individual medicines to inform the development  
            of policies that will ensure access to affordable medications.  
             Legislation is needed to enhance transparency in prescription  
            drug pricing so policymakers and purchasers can deliver on the  
            promise of health care coverage and affordability.  According  
            to the author, manufacturers should report data to the State  
            of California in order to provide taxpayers, policymakers and  
            consumers with insight into cost centers associated with drug  
            development and availability.
            2)BACKGROUND.  Specialty drugs offer striking therapeutic advances for a  
            range of very serious conditions, including cancer, hepatitis  
            C, rheumatoid arthritis, and multiple sclerosis.  The high  
            costs of specialty drugs are placing an increasing burden on  
            payers, employers, and patients.  Specialty drugs' high prices  
            raise questions about their affordability, whether their cost  
            is worth the clinical benefits they provide, and the financial  
            model of the current healthcare system.  Notably, new  
            Hepatitis C virus (HCV) treatment options that cure the  
            underlying disease with remarkable efficiency offer a drastic  
            improvement over previous therapies.  Payment systems will be  
            stressed in the short run by this cure, but will benefit in  
            the long run by the avoided downstream costs such as liver  
            transplants.  Policy makers are faced with balancing the need  
            to reward pharmaceutical breakthroughs in order to ensure the  
            innovation of future cures with the fact that payers and  
            patients have limited resources to afford very high prices.
          3)WHAT MAKES A DRUG "SPECIAL"?  Historically, a majority of  
            drugs approved by the US Food and Drug Administration (FDA)  


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            were small-molecule products, manufactured using simpler  
            processes, typically self-administered, and most often  
            dispensed through retail pharmacies.  Today, many drugs being  
            approved each year are being lumped into a poorly defined  
            group known as "high-priced specialty drugs."  These drugs are  
            often large molecule or biologic products; which means they  
            are produced using advanced biotechnology and may require  
            special administration, monitoring, and handling.  According  
            to a 2012 report by United Healthcare<1>, treatment for  
            complex or life-threatening health conditions now includes the  
            use of certain drugs broadly referred to as specialty drugs.   
            While no standard definition exists, specialty drugs generally  
            are defined as having one or more of the following  

             a)   Complex to manufacture, requiring special handling and  

             b)   Injectable or oral, self-administered or administered by  
               a health care provider;

             c)   Costly, both in total and on a per-patient basis (taken  
               by a relatively small share of the population who have  
               complex medical conditions); or,

             d)   Difficult for patients to take without ongoing clinical  
               support (making them challenging for providers to manage).




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            Historically, specialty drugs were usually injectable drugs  
            and were used to treat conditions like cancer, rheumatoid  
            arthritis, multiple sclerosis, and growth disorders; today,  
            their use has expanded beyond those conditions to include  
            treatment for other chronic and inflammatory conditions and  
            through other modes of administration.  The FDA has approved  
            about 300 drugs which many consider "specialty," compared to a  
            mere handful available two decades ago.  In recent years 70%  
            of new drugs approved by FDA have been specialty drugs.

          4)EXPENSIVE AND SPECIAL.  Most of the conditions targeted by  
            these specialty drugs tend to be chronic and progressive in  
            nature and can impact quality of life, along with morbidity  
            and mortality.  Examples include growth hormone disorders,  
            rheumatoid arthritis, asthma, multiple sclerosis, hepatitis C,  
            hemophilia, cancer, and lupus.  Cancer drugs represent a very  
            large segment of specialty drugs, and can cost up to $10,000  
            per month.  Cancer drugs traditionally are delivered either  
            through IV fluid or through injection in a physician's office  
            or hospital, and were often covered through the plan's medical  
            benefit, rather than pharmacy benefit.  Recently, oral  
            anticancer medications have also been used in cancer treatment  
            either as an adjunct to IV therapy, as a substitution for IV  
            therapy, or alone. Oral anticancer medications are being  
            prescribed more frequently for cancer treatment, and an  
            estimated 25% of anticancer agents currently in development  
            are oral cancer treatments.  With the advent of oral  
            chemotherapeutics, and recent changes in benefit designs, some  
            of most expensive drugs have been shifted to pharmacy benefit  
            instead of medical benefit.  


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            Another group of high-cost specialty drugs are "orphan drugs,"  
            those that are developed to treat very rare diseases.  The FDA  
            provides orphan status to drugs and biologics which are  
            intended for the treatment, diagnosis or prevention of rare  
            diseases/disorders that affect fewer than 200,000 people in  
            the U.S., or are not expected to recover the costs of  
            developing and marketing a treatment drug.  Because orphan  
            drugs treat very rare conditions, their high price tag is  
            often justified to balance the need to fund manufacturers'  
            research and development toward medical breakthroughs that  
            might not otherwise happen.  In recent years, concerns have  
            been raised by payers that manufacturers are charging prices  
            typically reserved for orphan drugs for new drugs that treat a  
            significantly larger population.  Due to expected approval of  
            more specialty drugs, the movement of expensive drugs into  
            pharmacy benefits, and charging specialty drug prices for  
            non-specialty drugs, the high cost of prescription drugs is at  
            the forefront for the public, payers, and policymakers.  

          5)COST SHARING TIERS.  Prescription drug benefits are a specific  
            type of covered benefit usually subject to cost sharing as  
            part of the medical benefit or a separate outpatient  
            prescription drug benefit.  The separate drug benefit designs  
            can be characterized by the number of tiers (up to four) into  
            which drug classes and specific medications are assigned.   
            Each tier has a distinct cost sharing level and/or form; the  
            lower tiers are less costly to both the enrollee and to the  
            health plan or insurer.  Some payers use a four-tier system  
            which includes specialty drugs in the fourth tier; typically  
            the most costly drugs.  The four-tier design frequently  
            results in greater enrollee out-of-pocket expenses.  

            In 2013, the annual California HealthCare Foundation employer  
            benefits survey found that 66% of covered California workers  
            had a three- or four-tier cost sharing formula for  
            prescription drugs.  Nationally, 82% of covered workers were  
            subject to three- or four-tier formulas.  


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          6)The $1,000 pill.  In December 2013, the FDA approved a drug  
            produced by Gilead Sciences called Sovaldi for the treatment  
            of HCV.  Sovaldi represents a significant advance in therapy  
            for HCV as it provides a higher cure rate, allows for a  
            shorter duration of treatment, has fewer adverse side effects,  
            and opens up treatment options for individuals with comorbid  
            conditions for which traditional treatments are  
            contraindicated.  While the drug has been found to be  
            remarkably effective (curing 90% or more patients over the  
            course of 12 weeks, according to the FDA), Gilead Sciences has  
            come under heavy fire for the price of the drug treatment.   
            Sovaldi is priced at $1,000 per pill, which brings the cost  
            associated with a 12-week treatment regimen to $84,000.   
            Gilead Sciences reported sales of $10.3 billion for Sovaldi in  
            2014 alone.  Critics have raised additional concerns due to  
            variation in costs globally.  According to an April 13, 2014  
            article in the San Francisco Chronicle, Gilead prices the  
            treatment at $57,000 in the United Kingdom, $66,000 in  
            Germany, while in Egypt and other developing countries the  
            treatment costs $900, which is 99% less than the U.S. cost. 

            After nearly a year of market exclusivity for Sovaldi, in late  
            2014 Abbvie gained FDA approval to market rival HCV treatment  
            Viekira Pak.  Pharmacy benefit managers (PBMs), like  
            ExpressScripts and CVS Caremark quickly signed deals agreeing  
            to exclusive coverage for specific brand drugs on their  
            formulary, in return for a hefty price discount on the drug.   
            At least two more competitor drugs are currently in final  
            stages of clinical trials and could be on the market in the  
            near future; the increased competition in the market is  
            expected to bring costs down significantly.  In early 2015,  
            Gilead announced it would be offering rebates of up to 46% on  


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            Sovaldi now that multiple rival drugs have entered the market.  

            Many insurers and government programs have tried to limit  
            their financial exposure by reserving Sovaldi and other new  
            drugs for patients with more advanced liver disease.  This has  
            raised concerns among patient advocates that cost-containment  
            measures might force patients to wait until their condition  
            has dangerously worsened before they are deemed eligible for  
            the cure.

          7)INCREASING DRUG COSTS.  A report by the IMS Institute for  
            Healthcare Informatics states that total U.S. spending on  
            medicines was $373.9 billion in 2014, an increase of 13.1%  
            from the amount spent in 2013<2>.  This is the highest single  
            year increase since 2001 (when growth reached 17.0%).  This  
            increase is attributed to a combination of increased pharmacy  
            usage by newly insured patients, increasing drug costs, and  
            fewer branded drugs losing patent exclusivity to generics.   
            Spending on specialty drugs dwarfs all other drugs.  Generic  
            drugs represent nearly 80% of drugs dispensed, and of the  
            remaining branded drugs, only about 3% are specialty drugs.   
            Despite that, over the past five years, specialty medicines  
            have accounted for 73% of total prescription drug spending  

            According to Centers for Medicare & Medicaid Services (CMS),  
            prescription drugs account for 10% of all healthcare dollars  
            spent.  Spending increases in all categories of health care  

          <2> IMS Institute for Healthcare Informatics. Global Outlook for  
          Medicines Through 2018. November 2014. 


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            each year.  The CMS National Health Expenditures (NHE) report  
            found that healthcare spending in all segments grew 3.6% in  
            2013.  CMS projected prescription drug spending growth would  
            be 6.4% in 2015, driven by increases in the use of  
            prescription drugs among people who are newly insured and  
            those who move to more generous insurance plans as a result of  
            the premium and cost-sharing subsidies offered by the Patient  
            Protection and Affordable Care Act (ACA).  In late 2014, IMS  
            projected that despite a temporary increase in U.S. spending  
            growth in 2014, it would moderate to 5 to 8% over the next few  
            years, coming back in-line with overall healthcare spending  

          8)EXCLUSIVITY, PATENTS, AND GENERIC DRUGS.  When new drugs come  
            to market, they are patented for approximately 10 to 12 years.  
             The time that a patent covers starts from the initial FDA  
            application, therefore, while patents generally cover a  
            molecule for 20 years, the time it takes each drug to come to  
            market varies, and therefore the remaining patented time  
            varies among drugs.  As drugs come off patent the presence of  
            generic competition dramatically reduces price.  For example,  
            blockbuster drugs such as Lipitor, Cymbalta and OxyContin have  
            recently come off patent as part of a wave of billions of  
            dollars' worth of brand blockbuster medications losing patent  
            protection<3>.  This led to unprecedented availability of  
            generic drugs, while the resulting competition among  
            manufacturers and suppliers of new generic medications drove  
            down drug costs substantially in most of the top therapy  
            classes.  The high rate of generic utilization in recent years  
            has led to more than 80% of prescriptions being now filled  
            with generic medicines.  However, the pace of price reductions  
            has begun to slow and some generic drugs; for example,  
            doxycycline and oxycodone, available generically for many  
            years, experienced considerable price increases in 2014.

          9)PRICE BENCHMARKS.  Knowing how much a drug costs is difficult;  

          <3> The 2014 Drug Trend report, Express Scripts Labs, March 2015


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            there are many different prices for each drug and different  
            ways of expressing those prices.  In the US, the two most  
            common ways of stating drug prices are the WAC and AWP.   
            Neither one, though, is a real price that anyone pays, nor are  
            they what their names imply.  Rather, they're standardized  
            ways of expressing a price, thus allowing comparisons to be  
            made from one drug to another.  AWP is a benchmark that has  
            been used for over 40 years for pricing and reimbursement of  
            prescription drugs for both government and private payers.   
            Initially, the AWP was intended to represent the average price  
            that wholesalers used to sell medications to providers, such  
            as physicians, pharmacies, and other customers.  However, the  
            AWP is not a true representation of actual market prices for  
            either generic or brand drug products.  AWP has often been  
            compared to the "list price" or "sticker price," meaning it is  
            an elevated drug price that is rarely what is actually paid.   
            AWP is not a government-regulated figure, does not include  
            buyer volume discounts or rebates often involved in  
            prescription drug sales.  As such, the AWP, while used  
            throughout the industry, is a controversial pricing benchmark.

          10)STICKER PRICE vs ACTUAL PRICE.   The WAC price of a drug on  
            the market, as originally announced by the company is rarely  
            the price paid.  The actual price paid by any one payer is  
            proprietary information, which complicates discussions of  
            value and cost to consumers.  Drug companies negotiate with  
            payers - Medicare, Medicaid, insurers, and pharmacy benefit  
            plans - to set an initial gross sales price.  Drug  
            manufacturers pay rebates back to government entities,  
            creating a difference between gross sales for a drug and net  
            sales.  The rebates are not publicly available, and vary  
            highly among payers and for different drugs.  Estimates put  
            them between 2%  for innovative new drugs all the way to 60%  
            for drugs that have several competitors are generics on the  



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            Federal law requires manufacturers to provide rebates to CMS  
            and state Medicaid agencies.  The program requires a drug  
            manufacturer to enter into, and have in effect, a national  
            rebate agreement with the Secretary of the Department of  
            Health and Human Services (HHS) in exchange for state Medicaid  
            coverage of most of the manufacturer's drugs.  These rebates  
            are paid by drug manufacturers on a quarterly basis to states  
            and are shared between the states and the Federal government  
            to offset the overall cost of prescription drugs under the  
            Medicaid program.  According to the Department of Healthcare  
            Services (DHCS), drug manufacturers are required to pay a  
            Medi-Cal rebate for all outpatient drugs that are dispensed  
            and paid for by the Medi-Cal program.  In addition, some  
            manufacturers have agreed to pay supplemental Medi-cal rebates  
            above the standard rebate.  Federal law requires rebates for  
            prescriptions offered through the AIDS Drug Assistance Program  
            (ADAP), in part because of the high cost of HIV/AIDS  
            medications.  According to the Kaiser Family Foundation, drug  
            manufacturer rebates account for 40% of the annual ADAP  

          11)The cost of developing drugs.  The research and development  
            process is complex, costly, and time-consuming.  According to  
            the California Biotechnology Foundation, it takes 10 to 15  
            years and costs $1.2 billion, on average, to advance on  
            potential new medicine from a research concept to an  
            FDA-approved treatment.  Failure is built into the research  
            system.  Roughly 95% of candidates entering clinical trial  
            will eventually fail.  On average, only one out of every 10  
            thousand potential new compounds becomes a new drug.   
            According to the Pharmaceutical Manufacturers of America  
            (PhRMA), out of every 5 to 10 thousand screened compounds,  
            only 250 enter preclinical testing, five enter human clinical  
            trials, and one is approved by the FDA. 



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            Due to the complexity and length of time invested in research,  
                     it is difficult for analysts and researchers to assess exactly  
            how much it costs to bring one drug to market.  The timeframe  
            of development can last for decades, and may be a combination  
            of efforts from multiple companies or previous research on  
            other drugs.  An analysis of publicly available data performed  
            by Forbes magazine in 2013 estimated the cost of bringing a  
            drug to market can vary from $350 Million to $4.5 Billion<5>.   

          12)PUBLICLY AVAILABLE INFORMATION.  Publicly traded  
            manufacturers report significant amounts of financial data to  
            shareholders and the government in annual U.S. Securities and  
            Exchange Commission filings.  The items include such things as  
            research and development costs, marketing, sales, advertising,  
            information technology, legal defense, the cost of raw  
            materials, and more.  These reports are filed on an annual  
            basis, and not compiled over the lifetime of drug development.  
             Additionally, these reports contain aggregate information for  
            all products on the market and currently being developed by a  
            manufacturer.  Some small companies might bring a single drug  
            to market in a given year, but larger companies might have  
            many drugs approved for market every year.  For example, in a  
            recent filing by Pfizer they stated that in one year they had  
            276 projects in all phases of development; 13 were in phase 3  
            clinical trials, 65 in earlier phases of clinical trials, and  


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            the remaining 200 were in very early discovery phases.  
            13)SUPPORT.  Supporters believe that this bill is necessary due to the  
            lack of transparency surrounding the pricing of prescription  
            drugs.  Proponents state that the public and policymakers  
            should know more about the pricing of drugs in order to  
            determine if the value is worth exorbitant costs.  The ACA has  
            increased transparency across our health care system but  
            unfortunately not regarding prescription drug costs and  
            pricing.  Anthem Blue Cross writes that this bill will bring  
            the increasing cost of pharmaceuticals into to the broader  
            conversation around how to control health care costs in the  
            coming years.  While the focus of controlling costs is  
            generally directed at health plans and insurers, it is time  
            for drug manufacturers and other entities to participate in  
            this conversation and offer solutions to reduce costs.  The  
            California School Employees Association and other supporters  
            believe that the information provided by this bill will  
            provide accountability into the pricing process and help the  
            public know what the costs are based on.  AIDS Healthcare  
            Foundation believes that the lack of drug pricing transparency  
            has been a detriment to the state and its citizens for too  
            long.  Many of the supporters argue that high prescription  
            drug prices affect the overall cost of delivering health care,  
            which threatens the long-term success of the ACA and put  
            enormous cost pressures on state and local governments.   
            Health Net states that health plans, insurers, hospitals, and  
            physicians are all required to submit extensive cost and  
            quality data to regulators to guide them in their policy  
            making.  If the high cost of these new specialty drugs is  
            justified by the investment the pharmaceutical companies have  
            made to develop, manufacture, and market these drugs then the  
            reporting requirements of this bill will demonstrate this. 
            14)OPPOSITION.  Opponents argue this bill will result in increased costs  
            without tangible results.  The Biotechnology Industry  
            Organization states that this bill does not provide adequate  
            context for the complex issue of pricing, which is based not  
            just on manufacturers' costs, but also on market forces and an  
            assessment of value that cannot simply be reduced to a few  
            lines on a balance sheet.  The Pharmaceutical Research and  


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            Manufacturers of American (PhRMA) opposes this bill and claims  
            it would create new burdensome reporting requirements on an  
            industry that should otherwise be dedicating its resources to  
            bringing new therapies and cures to prescribing physicians and  
            their patients.  PhRMA asserts that the information required  
            by this bill would be difficult to ascertain, and complying  
            with the reporting requirements imposed in the bill will be  
            costly for the life sciences industry.  The Orange County  
            Business Council states that these types of disclosures are  
            limited due to confidentiality and proprietary reasons because  
            substantial competitive information can be gleaned from costs  
            associated with specific research and development information  
            and sales and marketing information by marketplace  
            LEGISLATION.  AB 339 (Gordon) limits copayments, coinsurance,  
            and other cost sharing for specialty drugs to 1/24 of the  
            annual out-of-pocket limit applicable to individual coverage  
            for a supply of up to 30 days (about $275 for the 2015 plan  
            year).  Prohibits a plan or contract from placing all or most  
            of the prescription medications that treat a specific  
            condition on the highest cost tier tiers of their drug  
            formulary.  Creates a framework for assigning specialty drugs  
            into formulary tiers.  This bill is pending in this Committee.  


             a)   Finite timeframe of reporting.  Generally accepted  
               accounting principles require companies to keep records  
               going back seven years.  As drafted, this bill would  
               require disclosure of financial information regarding the  
               entire development process of a drug, which could  
               potentially go back over a decade or more.  The author  
               should limit disclosure of information going back a finite  
               number of years, such as the previous seven years.

             b)   Reporting the cost of failed drugs.  Most potential  


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               compounds never make it all the way to being an approved  
               drug.  Companies invest significant resources in research  
               and development of projects that ultimately fail, which is  
               a factor in determining their business model.  The author  
               should amend this bill to include a provision for reporting  
               aggregate expenditures on developing drugs that fail to  
               succeed through the process to market approval. 

             c)   Proprietary and contract information.  Some of the  
               information that would be provided by companies pursuant to  
               this bill might be proprietary.  For example, wholesale  
               materials and manufacturing costs could reveal proprietary  
               business information.  The licensing and acquisition costs  
               of purchasing another business are often kept confidential  
               under the terms and conditions of that contract.  The  
               requirements of this bill might open the state to  
               liability.  The author should amend the bill to ensure that  
               proprietary or trade secreted information is kept  
               confidential by OSHPD. 



          AIDS Healthcare Foundation
          America's Health Insurance Plans
          Anthem Blue Cross
          Association of California Life and Health Insurance Companies
          Blue Shield of California
          California Association of Health Plans
          California Hepatitis Alliance
          California Labor Federation
          California Nurses Association 


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          California PACE Association
          California Professional Firefighters
          California School Employees Association
          California Teachers Association
          Consumers Union
          Fresno Chamber of Commerce
          Greater West Covina Business Association
          Health Access
          Health Net
          Industry Manufacturers Council
          Kaiser Permanente
          Laborers International Union of North America Local 777 and 792
          Los Angeles Area Chamber of Commerce
          Molina Healthcare
          Montebello Chamber of Commerce
          National Multiple Sclerosis Society
          Ontario Chamber of Commerce
          Richmond Chamber of Commerce
          San Gabriel Valley Economic Partnership
          San Gabriel Valley Regional Chamber of Commerce
          San Ramon Chamber of Commerce
          SEIU California
          Small Business Majority
          State Building and Construction Trades Council, AFL-CIO
          Torrance Area Chamber of Commerce
          Torrance Area Chamber of Commerce Governmental Affairs Policy  
          UFCW Western States Council
          Valley Industry and Commerce Association
          Young Professionals Chronic Disease Network

          Astellas Pharma


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          BioMarin Pharmaceutical
          Biotechnology Industry Organization
          California Healthcare Institute
          California Manufacturers & Technology Association
          Irvine Chamber of Commerce
          Orange County Business Council
          Otsuka Pharmaceutical Development & Commercialization, Inc
          Pharmaceuticals Research and Manufacturers of America
          Takeda Pharmaceutical Company

          Analysis Prepared  
          by:              Dharia McGrew / HEALTH / (916) 319-2097