A07588 Summary:

SPONSORGottfried (MS)
COSPNSRArroyo, Barron, Blake, Cahill, Cook, Dinowitz, Englebright, Galef, Gunther, Hunter, Lavine, Lifton, Magnarelli, Miller MG, Montesano, Ortiz, Ramos, Rivera, Rosenthal L, Seawright, Simon, Zebrowski, Jacobson, Stirpe, Hevesi, Carroll, Mikulin, Reyes, DenDekker, Benedetto, D'Urso, Cruz, Epstein, Colton, Niou
MLTSPNSRButtenschon, Lentol, Lupardo, Thiele
Add 280-d, Pub Health L
Creates a wholesale prescription drug importation program which complies with federal standards and regulations for the purpose of generating substantial savings for consumers.
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A07588 Actions:

05/10/2019referred to higher education
01/08/2020referred to higher education
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A07588 Memo:

submitted in accordance with Assembly Rule III, Sec 1(f)
SPONSOR: Gottfried (MS)
  TITLE OF BILL: An act to amend the public health law, in relation to creating a wholesale prescription drug importation program   PURPOSE OR GENERAL IDEA OF BILL: to create a state program to import prescription drugs from other coun- tries at lower cost.   SUMMARY OF SPECIFIC PROVISIONS: The Commissioner of Health will seek federal certification for a program under which an approved wholesaler may import drugs that meet U.S. Food and Drug Administration standards from only suppliers who are regulated and authorized under the laws of their country for distribution and sale only in New York. The operation of the program will be funded by annual fees paid by the authorized wholesaler. The Commissioner will make regulations to require and authorized wholesaler application process, reporting and audits; collaborate with the Attorney General to combat fraud; seek all required federal approvals for participation including those required for the 340-B program; and report annually to the legislature.   JUSTIFICATION: Concern about drug pricing is at an all-time high. Studies show how U.S. consumers pay the highest prices in the world for life-saving and enhancing drug treatments. The prices we pay may fund the research and development that benefits the entire world but those same prices make treatment options unavailable here at home if patients cannot afford their medicines or public programs cannot finance expensive treatments for everyone in need. Drug importation is high on the list of solutions the public wants to pursue. Federal law allows the Secretary of Health and Human Services (HHS) to certify programs for personal and wholesale importation from countries such as Canada if consumer safety is on par with the U.S. drug supply chain system and significant consumer cost savings are realized. Under the federal law, shipments from Canada, for example, will be test- ed on a sample basis for purity and potency and products would be labeled properly for the U.S. market and distributed to retail pharma- cies and other settings included in the program. Just as in the regular commercial market, retail pharmacies and other dispensing settings order and pay for products, and administrative costs set by the Commissioner. The product acquisition cost will be the Canadian price. Pharmacies and other dispensers will charge the Canadian price without mark-up, except for cost-based dispensing fee, for uninsured people or people in their deductible period. Health plans and other payers will pay dispensers for the product at the Canadian price without mark-up except for cost-based dispensing fee. Medical care is a fundamental fact of life at some point or another, but the burden of paying for that care should not, on its own, be the death of us.   PRIOR LEGISLATIVE HISTORY: New bill.   FISCAL IMPLICATIONS: None   EFFECTIVE DATE: Immediately.
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A07588 Text:

                STATE OF NEW YORK
                               2019-2020 Regular Sessions
                   IN ASSEMBLY
                                      May 10, 2019
        Introduced  by M. of A. GOTTFRIED, ARROYO, ASHBY, BARRON, BLAKE, CAHILL,
          L. ROSENTHAL, SEAWRIGHT, SIMON, ZEBROWSKI -- Multi-Sponsored by --  M.
          of  A.  LUPARDO,  THIELE -- read once and referred to the Committee on
          Higher Education
        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. 7588                             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.
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