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S04986 Summary:

BILL NOS04986
 
SAME ASNo Same As
 
SPONSORDIAZ
 
COSPNSR
 
MLTSPNSR
 
Add §278-a, Pub Health L
 
Enacts the pharmaceutical cost transparency act requiring prescription drug manufacturers to file a report disclosing certain financial information pertaining to prescription drugs which have a wholesale acquisition cost of $10,000 or more annually or per course of treatment.
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S04986 Actions:

BILL NOS04986
 
03/03/2017REFERRED TO HEALTH
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S04986 Committee Votes:

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S04986 Floor Votes:

There are no votes for this bill in this legislative session.
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S04986 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                          4986
 
                               2017-2018 Regular Sessions
 
                    IN SENATE
 
                                      March 3, 2017
                                       ___________
 
        Introduced  by  Sen.  DIAZ  --  read twice and ordered printed, and when
          printed to be committed to the Committee on Health
 
        AN ACT to amend the public health law, in relation to  establishing  the
          pharmaceutical cost transparency act of 2017
 
          The  People of the State of New York, represented in Senate and Assem-
        bly, do enact as follows:
 
     1    Section 1. This act shall be cited and may be known as the "pharmaceu-
     2  tical cost transparency act of 2017".
     3    § 2. The public health law is amended by adding a new section 278-a to
     4  read as follows:
     5    § 278-a. Prescription drug cost transparency. 1.  Legislative  intent.
     6  a.  It is the intent of the legislature to make information available to
     7  the public about the cost of ultra-high-priced pharmaceuticals, in order
     8  to make pharmaceutical pricing as transparent as the  pricing  in  other
     9  sectors of the health care industry.
    10    b. The legislature finds that there should be annual cost reporting on
    11  the  most  expensive drugs that would be of use to policymakers, govern-
    12  ment agencies, and  others  to  understand  costs  for  these  important
    13  products.
    14    2.  Each  manufacturer  of  a prescription drug, made available in New
    15  York, that has a wholesale acquisition  cost  of  ten  thousand  dollars
    16  ($10,000)  or  more  annually  or  per course of treatment, shall file a
    17  report pursuant to this section on the costs for each qualifying drug.
    18    3. The report required pursuant to subdivision  two  of  this  section
    19  shall include all of the following for each drug:
    20    a.  The  total  costs for the production of the drug, including all of
    21  the following:
    22    (i) The total research and development costs paid by the manufacturer,
    23  and separately, the total research and development  costs  paid  by  any
    24  predecessor in the development of the drug.
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD07382-01-7

        S. 4986                             2
 
     1    (ii)  The  total  costs  of clinical trials and other regulatory costs
     2  paid by the manufacturer, and separately, the total  costs  of  clinical
     3  trials  and other regulatory costs paid by any predecessor in the devel-
     4  opment of the drug.
     5    (iii) The total costs for materials, manufacturing, and administration
     6  attributable to the drug.
     7    (iv) The total costs paid by any entity other than the manufacturer or
     8  predecessor  for  research  and  development,  including any amount from
     9  federal, state, or other governmental programs or any form of subsidies,
    10  grants, or other support.
    11    (v) Any other costs to acquire  the  drug,  including  costs  for  the
    12  purchase  of  patents,  licensing or acquisition of any corporate entity
    13  owning any rights to the drug while in development, or all of these.
    14    (vi) The total marketing and advertising costs for  the  promotion  of
    15  the  drug  directly  to  consumers, including, but not limited to, costs
    16  associated with direct to consumer coupons and  amount  redeemed,  total
    17  marketing  and  advertising  costs for promotion of the drug directly or
    18  indirectly to prescribers, and any other advertising for the drug.
    19    b. A cumulative annual history of average wholesale price  and  whole-
    20  sale acquisition cost increases for the drug (expressed as percentages),
    21  including  the  months each increase in each category, average wholesale
    22  price and wholesale acquisition cost, took effect.
    23    c. The total profit attributable to the drug as represented  in  total
    24  dollars  and  represented  as  a percentage of the total company profits
    25  that were derived from the sale of the drug.
    26    d. The total amount  of  financial  assistance  the  manufacturer  has
    27  provided through patient prescription assistance programs, if available.
    28    4.  All  of the information in subdivision three of this section shall
    29  be itemized and documented by the manufacturer, and audited by  a  fully
    30  independent third-party auditor prior to filing.
    31    5.  The  information  required by this section shall be filed annually
    32  with the department on a form prescribed by the department and shall  be
    33  submitted no later than May first of each year.
    34    6.  Notwithstanding  any  other  section  of  law to the contrary, the
    35  department shall issue a report annually to  the  legislature  outlining
    36  the  information  submitted pursuant to this section, and the department
    37  shall post the report publicly on its website.
    38    7. The department shall convene an advisory panel to develop the  form
    39  required  by  this  section.  The  panel  shall include, but need not be
    40  limited to, representatives from  the  pharmaceutical  industry,  health
    41  care service plans and insurers, pharmacy benefit managers, governmental
    42  agencies, consumer advocates, and physicians.
    43    § 3. This act shall take effect immediately.
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