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S04786 Summary:

BILL NOS04786A
 
SAME ASNo Same As
 
SPONSORRIVERA
 
COSPNSRCOONEY, MAY
 
MLTSPNSR
 
Add Art 2-A Title IV §§282 - 285, Pub Health L
 
Enacts the "New York affordable drug manufacturing act" to direct the commissioner of health to enter into partnerships to increase competition, lower prices, and address shortages in the market for generic prescription drugs, to reduce the cost of prescription drugs for public and private purchasers, taxpayers, and consumers, and to increase patient access to affordable drugs.
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S04786 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                         4786--A
 
                               2023-2024 Regular Sessions
 
                    IN SENATE
 
                                    February 14, 2023
                                       ___________
 
        Introduced  by  Sen.  RIVERA -- read twice and ordered printed, and when
          printed to be committed  to  the  Committee  on  Health  --  committee
          discharged, bill amended, ordered reprinted as amended and recommitted
          to said committee
 
        AN  ACT to amend the public health law, in relation to enacting the "New
          York affordable drug manufacturing act"

          The People of the State of New York, represented in Senate and  Assem-
        bly, do enact as follows:
 
     1    Section  1.  Short  title. This act shall be known and may be cited as
     2  the "New York affordable drug manufacturing act".
     3    § 2. Article 2-A of the public health law is amended by adding  a  new
     4  title IV to read as follows:
     5                                  TITLE IV
     6                 NEW YORK AFFORDABLE DRUG MANUFACTURING ACT
     7  Section 282. Definitions.
     8          283. Partnerships;   production   and  distribution  of  generic
     9                 prescription drugs.
    10          284. Reporting.
    11          285. Proprietary information.
    12    § 282. Definitions. As used in this title, the following  terms  shall
    13  have the following meanings:
    14    1.  "Generic prescription drug" means a drug that is approved pursuant
    15  to an application submitted under subdivision (j) of section 355 of  the
    16  Federal Food, Drug, and Cosmetic Act (21 U.S.C.  Sec. 301 et seq.), or a
    17  biosimilar,  as  defined under the federal Public Health Service Act (42
    18  U.S.C. Sec. 262) that is not under patent.
    19    2. "Partnerships" means agreements  for  the  procurement  of  generic
    20  prescription  drugs  by way of contracts or purchasing by a payer, state
    21  governmental agency, group purchasing organization, nonprofit  organiza-
    22  tion, or other entity.
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD08090-02-3

        S. 4786--A                          2
 
     1    §   283.   Partnerships;   production   and  distribution  of  generic
     2  prescription drugs. 1. (a) The commissioner shall  enter  into  partner-
     3  ships, consistent with paragraph (b) of subdivision two of this section,
     4  in  consultation  with all appropriate state agencies and the department
     5  of  health or equivalent institution of any other state as determined by
     6  the commissioner, to increase competition,  lower  prices,  and  address
     7  shortages  in  the  market for generic prescription drugs, to reduce the
     8  cost of prescription drugs for public and private purchasers, taxpayers,
     9  and consumers, and to increase patient access to affordable drugs.
    10    (b) The department shall have the ability to hire staff to oversee and
    11  project-manage the partnerships for  manufacturing  or  distribution  of
    12  generic prescription drugs.
    13    2. (a) The commissioner shall enter into partnerships resulting in the
    14  production  or  distribution  of  generic  prescription  drugs, with the
    15  intent that these drugs be made widely available to public  and  private
    16  purchasers, facilities licensed pursuant to article twenty-eight of this
    17  chapter, and pharmacies as defined in section six thousand eight hundred
    18  two of the education law, as appropriate. The generic prescription drugs
    19  shall  be  produced  or  distributed  by  a drug company or generic drug
    20  manufacturer that is registered with the United  States  Food  and  Drug
    21  Administration.
    22    (b)  (i)  The commissioner shall only enter into partnerships pursuant
    23  to paragraph (a) of this subdivision to produce a  generic  prescription
    24  drug  at a price that results in savings, targets failures in the market
    25  for generic drugs, and improves patient  access  to  affordable  medica-
    26  tions.
    27    (ii)  For  top  drugs  identified  pursuant  to the criteria listed in
    28  subparagraph (v) of this paragraph, the department  shall  determine  if
    29  viable  pathways  exist  for  partnerships  to manufacture or distribute
    30  generic prescription drugs by  examining  the  relevant  legal,  market,
    31  policy, and regulatory factors.
    32    (iii) The department shall consider the following, if applicable, when
    33  setting the price of the generic prescription drug:
    34    (1) United States Food and Drug Administration user fees.
    35    (2)  Abbreviated new drug application acquisition costs amortized over
    36  a five-year period.
    37    (3) Mandatory rebates.
    38    (4) Total contracting and production costs for the drug,  including  a
    39  reasonable  amount  for  administrative,  operating,  and rate-of-return
    40  expenses of the drug company or generic drug manufacturer.
    41    (5) Research and development costs attributed to the drug over a five-
    42  year period.
    43    (6) Other initial start-up costs amortized over a five-year period.
    44    (iv) Each drug shall be made available  to  providers,  patients,  and
    45  purchasers at a transparent price and without rebates, other than feder-
    46  ally required rebates.
    47    (v)   The   department  shall  prioritize  the  selection  of  generic
    48  prescription drugs that have the greatest impact on lowering drug  costs
    49  to  patients,  increasing  competition  and  addressing shortages in the
    50  prescription drug market, improving public health, or reducing the  cost
    51  of prescription drugs to public and private purchasers.
    52    (c)  (i) In identifying generic prescription drugs to be produced, the
    53  department shall consider prescription  drug  retail  price  lists  made
    54  pursuant to section two hundred seventy-eight of this article.
    55    (ii)  The  partnerships entered into pursuant to paragraph (a) of this
    56  subdivision shall include the production of at least one form  of  insu-

        S. 4786--A                          3
 
     1  lin,  provided that a viable pathway for manufacturing a more affordable
     2  form of insulin exists.
     3    (iii)  The department shall prioritize drugs for chronic and high-cost
     4  conditions.
     5    (d) The department shall consult with all of the following public  and
     6  private   purchasers   to   assist  in  developing  a  list  of  generic
     7  prescription drugs to be manufactured or  distributed  through  partner-
     8  ships and to determine the volume of each generic prescription drug that
     9  can  be procured over a multiyear period to support a market for a lower
    10  cost generic prescription drug:
    11    (i) The department of mental  hygiene,  the  office  for  people  with
    12  developmental  disabilities,  the  office  of  general services, and the
    13  department of corrections and community  supervision,  or  the  entities
    14  acting on behalf of each of those state purchasers.
    15    (ii) Health insurers licensed pursuant to the insurance law.
    16    (iii) Hospitals.
    17    (iv) Any other entity as determined by the commissioner.
    18    (e)  Before  effectuating  a partnership pursuant to this section, the
    19  commissioner shall determine minimum thresholds for  procurement  of  an
    20  entity's expected volume of a targeted drug from the company or manufac-
    21  turer over a multiyear period.
    22    (f)   All  state  agencies  shall  be  required  to  purchase  generic
    23  prescription drugs from the department  or  entities  that  contract  or
    24  partner with the department pursuant to this chapter.
    25    (g)  The department shall not be required to consult with every entity
    26  listed in subparagraphs (ii), (iii) and (iv) of paragraph  (d)  of  this
    27  subdivision,  so  long  as  purchaser  engagement  includes a reasonable
    28  representation from these groups.
    29    § 284. Reporting. 1. On or before January first, two thousand  twenty-
    30  six,  the  department  shall  submit  a  report  to the legislature that
    31  assesses the feasibility of directly manufacturing generic  prescription
    32  drugs and selling generic prescription drugs at a fair price. The report
    33  shall  include,  but not be limited to, an analysis of governance struc-
    34  ture options for manufacturing functions, including chartering a private
    35  organization, a public-private partnership, or a public board of  direc-
    36  tors.
    37    2.  On or before March first, two thousand twenty-five, the department
    38  shall report to the legislature on both of the following:
    39    (a) A description of the status of all drugs targeted under this chap-
    40  ter.
    41    (b) An analysis of how the activities of  the  department  may  impact
    42  competition, access to targeted drugs, the costs of those drugs, and the
    43  costs of generic prescription drugs to public and private purchasers.
    44    §  285.  Proprietary information. Notwithstanding any provision of law
    45  to the contrary, all nonpublic information and documents obtained by the
    46  department pursuant to this title shall not be required to be  disclosed
    47  pursuant to article six of the public officers law.
    48    § 3. Severability. If any clause, sentence, paragraph, section or part
    49  of  this act shall be adjudged by any court of competent jurisdiction to
    50  be invalid and after exhaustion of  all  further  judicial  review,  the
    51  judgment  shall  not affect, impair or invalidate the remainder thereof,
    52  but shall be confined in its operation to the  clause,  sentence,  para-
    53  graph,  section or part of this act directly involved in the controversy
    54  in which the judgment shall have been rendered.
    55    § 4. This act shall take effect on the first of January next  succeed-
    56  ing one year after it shall have become a law.
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