Bill Text: NY A07954 | 2023-2024 | General Assembly | Introduced

Bill Title: Creates a wholesale prescription drug importation program which complies with federal standards and regulations for the purpose of generating substantial savings for consumers.

Spectrum: Partisan Bill (Democrat 24-1)

Status: (Introduced) 2023-08-18 - referred to higher education [A07954 Detail]

Download: New_York-2023-A07954-Introduced.html

                STATE OF NEW YORK


                               2023-2024 Regular Sessions

                   IN ASSEMBLY

                                     August 18, 2023

        Introduced  by  M. of A. SIMON, COOK, DINOWITZ, GUNTHER, HUNTER, LAVINE,
          FORREST, JACKSON -- Multi-Sponsored by -- M. of A. BUTTENSCHON, LUPAR-
          DO, THIELE -- read once and referred to the Committee on Higher Educa-

        AN  ACT to amend the public health law, in relation to creating a whole-
          sale prescription drug importation program

          The People of the State of New York, represented in Senate and  Assem-
        bly, do enact as follows:

     1    Section  1. Title 2 of article 2-A of the public health law is amended
     2  by adding a new section 280-d to read as follows:
     3    § 280-d. Wholesale prescription drug  importation  program.    1.  (a)
     4  There  is hereby created in the department a wholesale prescription drug
     5  importation program.
     6    (b) As used in this  section,  unless  the  context  clearly  requires
     7  otherwise, the following terms shall have the following meanings:
     8    (i)  "Wholesale  prescription  drug  importation program" or "program"
     9  means the wholesale prescription drug importation program created  under
    10  this section.
    11    (ii)  "Prescription  drug  wholesaler"  means  an entity authorized to
    12  acquire prescription drugs and sell or distribute them wholesale in  the
    13  state.
    14    (iii)  "Approved  wholesaler"  means  a  prescription  drug wholesaler
    15  approved under this section to participate in the program.
    16    (c) The commissioner  shall  develop  and  implement  the  program  in
    17  consultation  with interested stakeholders and appropriate federal offi-
    18  cials. The program shall comply with  applicable  federal  requirements,
    19  including  21  U.S.C.  § 384, and requirements regarding safety and cost
    20  savings. Under the program:

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.

        A. 7954                             2

     1    (i) the commissioner shall  approve  one  or  more  prescription  drug
     2  wholesalers  to  seek  federal  certification  and  approval  to  import
     3  prescription drugs from one or more  other  countries,  to  be  sold  or
     4  distributed wholesale in the state;
     5    (ii)  prescription  drugs  shall only be acquired from suppliers regu-
     6  lated and authorized under the laws of the other country or a  jurisdic-
     7  tion thereof;
     8    (iii)  only prescription drugs meeting the U.S. Food and Drug Adminis-
     9  tration's safety, effectiveness, and other standards shall  be  imported
    10  under the program;
    11    (iv)  only prescription drugs expected to generate substantial savings
    12  for consumers shall be imported;
    13    (v) the approved wholesaler shall at all times comply with the  track-
    14  ing  and tracing requirements of 21 U.S.C. §§ 360eee and 360eee-1 to the
    15  extent feasible and practical, including prior to imported  prescription
    16  drugs coming into its possession;
    17    (vi)  an approved wholesaler shall not sell or distribute prescription
    18  drugs imported under the program outside the state;
    19    (vii) the commissioner may impose an annual  fee  on  approved  whole-
    20  salers,  which  may  be  based  in  whole  or  in  part  on the value of
    21  prescription  drugs  imported  by  the  approved  wholesaler  under  the
    22  program, to support the operation of the program;
    23    (viii)  every  approved wholesaler shall provide the commissioner with
    24  information on its participation in the program as  reasonably  required
    25  by  the  commissioner;  the commissioner may provide for keeping certain
    26  information confidential within the department where  reasonably  neces-
    27  sary for successful operation of the program; and
    28    (ix)  the  commissioner  shall  provide  for  auditing of the program,
    29  including making sure that prescription  drugs  are  made  available  at
    30  substantial savings to consumers as a result of the program.
    31    (d)  The  commissioner  shall  make regulations and take other actions
    32  reasonably necessary to implement the program.
    33    2. The commissioner shall consult with the attorney general to identi-
    34  fy the potential for, and to monitor, anticompetitive behavior under  or
    35  in relation to the program.
    36    3. (a) The commissioner shall seek all necessary approvals and certif-
    37  ication  by  the  secretary  of  the U.S. Department of Health and Human
    38  Services or other appropriate federal  officials  or  agencies  for  the
    39  wholesale prescription drug importation program.
    40    (b)  The  commissioner  shall  seek the appropriate federal approvals,
    41  waivers, exemptions, or agreements, or a combination thereof, as  needed
    42  to  enable  all covered entities enrolled in or eligible for the federal
    43  340B drug pricing program to participate in the  wholesale  prescription
    44  drug importation program to the fullest extent possible without jeopard-
    45  izing their eligibility for the 340B program.
    46    4.  The  commissioner shall establish procedures for prescription drug
    47  wholesalers to apply and be  approved  to  be  an  approved  wholesaler,
    48  including  requirements  for  periodic  renewal  of  that  approval. The
    49  commissioner shall provide reasonable grounds for suspending or revoking
    50  approval of an approved wholesaler under this section, including reason-
    51  able provision for notice, opportunity to be heard, and appeal.
    52    5. The commissioner shall annually report to the  assembly  committees
    53  on  health and on ways and means and the senate committees on health and
    54  on finance regarding the operation of the  wholesale  prescription  drug
    55  importation program.
    56    § 2. This act shall take effect immediately.