Bill Text: NY S05682 | 2019-2020 | 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 6-0)

Status: (Introduced) 2019-05-10 - REFERRED TO HEALTH [S05682 Detail]

Download: New_York-2019-S05682-Introduced.html

                STATE OF NEW YORK


                               2019-2020 Regular Sessions

                    IN SENATE

                                      May 10, 2019

        Introduced  by  Sen. SKOUFIS -- 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 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:
    21    (i)  the  commissioner  shall  approve  one  or more prescription drug
    22  wholesalers  to  seek  federal  certification  and  approval  to  import
    23  prescription  drugs  from  one  or  more  other countries, to be sold or
    24  distributed wholesale in the state;

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

        S. 5682                             2

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