NY State Senate Bill 2023-S9838

Current Bill Status - On Floor Calendar

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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Actions

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jun 07, 2024	ordered to third reading rules cal.612 substituted for a7954a
Jun 06, 2024	referred to higher education delivered to assembly passed senate ordered to third reading cal.1877
Jun 03, 2024	referred to rules

Votes

- Jun 6, 2024 - Floor Vote
  S9838
  
  59
  
  Aye
  
  2
  
  Nay
  
  0
  
  Absent
  
  1
  
  Excused
  
  0
  
  Abstained
  - - Floor Vote: Jun 6, 2024
      
      aye (59)
      
      Addabbo Jr.
      
      Ashby
      
      Bailey
      
      Breslin
      
      Brisport
      
      Brouk
      
      Canzoneri-Fitzpatrick
      
      Chu
      
      Cleare
      
      Comrie
      
      Cooney
      
      Felder
      
      Fernandez
      
      Gianaris
      
      Gonzalez
      
      Gounardes
      
      Griffo
      
      Harckham
      
      Helming
      
      Hinchey
      
      Hoylman-Sigal
      
      Jackson
      
      Kavanagh
      
      Krueger
      
      Lanza
      
      Liu
      
      Mannion
      
      Martinez
      
      Martins
      
      Mattera
      
      May
      
      Mayer
      
      Murray
      
      Myrie
      
      O'Mara
      
      Oberacker
      
      Ortt
      
      Palumbo
      
      Parker
      
      Persaud
      
      Ramos
      
      Rhoads
      
      Rivera
      
      Rolison
      
      Ryan
      
      Salazar
      
      Sanders Jr.
      
      Scarcella-Spanton
      
      Sepúlveda
      
      Serrano
      
      Skoufis
      
      Stavisky
      
      Stec
      
      Stewart-Cousins
      
      Tedisco
      
      Thomas
      
      Webb
      
      Weber
      
      Weik
      
      nay (2)
      
      Borrello
      
      Gallivan
      
      excused (1)
      
      Walczyk

2023-S9838 (ACTIVE) - Details

See Assembly Version of this Bill:: A7954
Law Section:: Public Health Law
Laws Affected:: Add §280-d, Pub Health L; amd §6808, Ed L
Versions Introduced in Other Legislative Sessions:: 2019-2020: A7588
2021-2022: A133

2023-S9838 (ACTIVE) - Summary

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

2023-S9838 (ACTIVE) - Sponsor Memo

                                 
BILL NUMBER: S9838

SPONSOR: SKOUFIS
 
TITLE OF BILL:

An act to amend the public health law and the education law, in relation
to creating a wholesale prescription drug importation program

 
PURPOSE:

To create a state program to import prescription drugs from other coun-
tries at lower cost.

 
SUMMARY OF PROVISIONS:

Section one adds a new section 280-d to the Public Health Law to direct
the Commissioner of Health, in consultation with the Commissioner of
Education, to design a wholesale prescription drug importation program
for the wholesale importation of prescription drugs from Canada. The
prescription drugs imported under the program would be restricted to
those that meet certain standards, including drugs that are expected to
generate substantial savings for consumers in NY.

Under the bill, the Commissioner of Health would seek all necessary
federal certifications and/or approvals for the program. The Department
of Health would be authorized to impose annual fees on approved whole-
salers to support the operation of the program.  Additionally, the
Department of Health would promulgate regulations in consultation with
the State Education Department and report annually to the legislature.

Section two adds a new subdivision 10 to section 6808 of the Education
Law to prohibit a wholesaler from participating in the wholesale drug
importation program without prior application and approval by the State
Education Department

Section three sets forth the effective date.

 
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.

 
LEGISLATIVE HISTORY:

New bill

 
FISCAL IMPLICATIONS:

To be determined.

 
EFFECTIVE DATE:
This act shall take effect 18 months after it shall have become a law.
Effective immediately, the addition, amendment and/or repeal of any rule
or regulation necessary for the implementation of this act on its effec-
tive date are authorized to be made and completed on or before such
effective date.

2023-S9838 (ACTIVE) - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   9838
 
                             I N  S E N A T E
 
                               June 3, 2024
                                ___________
 
 Introduced  by  Sen. SKOUFIS -- read twice and ordered printed, and when
   printed to be committed to the Committee on Rules
 
 AN ACT to amend the public health law and the education law, in relation
   to creating a wholesale prescription drug importation program
 
   THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
 BLY, DO ENACT AS FOLLOWS:

   Section  1.  The  public health law is amended by adding a new section
 280-d to read as follows:
   § 280-D. WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM.  1. AS  USED
 IN THIS SECTION,  THE FOLLOWING TERMS SHALL HAVE THE FOLLOWING MEANINGS:
   (A)  "WHOLESALE  PRESCRIPTION  DRUG  IMPORTATION PROGRAM" OR "PROGRAM"
 MEANS THE WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM CREATED  UNDER
 THIS SECTION.
   (B)  "PRESCRIPTION  DRUG  WHOLESALER"  MEANS  AN  ENTITY AUTHORIZED TO
 ACQUIRE PRESCRIPTION DRUGS AND SELL OR DISTRIBUTE THEM WHOLESALE IN  THE
 STATE.
   (C) "APPROVED WHOLESALER" MEANS A PRESCRIPTION DRUG WHOLESALER AUTHOR-
 IZED TO PARTICIPATE IN THE IMPORTATION PROGRAM UNDER THIS SECTION PURSU-
 ANT  TO  APPROVAL BY THE STATE EDUCATION DEPARTMENT UNDER SECTION SIXTY-
 EIGHT HUNDRED EIGHT OF THE EDUCATION LAW.
   2. THE COMMISSIONER, IN CONSULTATION WITH THE COMMISSIONER  OF  EDUCA-
 TION  AND  OTHER  APPROPRIATE FEDERAL AND STATE AGENCIES, SHALL DESIGN A
 WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM FOR THE WHOLESALE IMPOR-
 TATION OF PRESCRIPTION DRUGS  FROM  CANADA.  THE  PROGRAM  DESIGN  SHALL
 COMPLY  WITH APPLICABLE FEDERAL REQUIREMENTS, INCLUDING 21 U.S.C. § 384,
 AND REQUIREMENTS REGARDING SAFETY AND COST SAVINGS.  UNDER  THE  PROGRAM
 DESIGN:
   (A)   PRESCRIPTION   DRUGS   SHALL  ONLY  BE  ACQUIRED  FROM  CANADIAN
 PRESCRIPTION DRUG SUPPLIERS REGULATED AND AUTHORIZED UNDER THE  LAWS  OF
 CANADA OR ONE OR MORE CANADIAN PROVINCES, OR BOTH;
   (B) ONLY PRESCRIPTION DRUGS MEETING THE FEDERAL FOOD AND DRUG ADMINIS-
 TRATION'S  SAFETY,  EFFECTIVENESS,  MISBRANDING,  ADULTERATION AND OTHER
 STANDARDS SHALL BE IMPORTED UNDER THE PROGRAM;
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD03404-08-4

 S. 9838                             2
 
   (C) ONLY PRESCRIPTION DRUGS EXPECTED TO GENERATE  SUBSTANTIAL  SAVINGS
 FOR CONSUMERS IN THE STATE SHALL BE IMPORTED;
   (D) THE PRESCRIPTION DRUG IS NOT:
   (I) A CONTROLLED SUBSTANCE AS DEFINED IN 21 U.S.C. § 802;
   (II) A BIOLOGICAL PRODUCT AS DEFINED IN 42 U.S.C. § 262;
   (III) AN INFUSED DRUG, INCLUDING A PERITONEAL DIALYSIS SOLUTION;
   (IV) AN INTRAVENOUSLY INJECTED DRUG;
   (V) A DRUG THAT IS INHALED DURING SURGERY;
   (VI)  A  DRUG  WHICH IS A PARENTERAL DRUG, THE IMPORTATION OF WHICH IS
 DETERMINED BY THE UNITED STATES SECRETARY OF HEALTH AND  HUMAN  SERVICES
 TO POSE A THREAT TO PUBLIC HEALTH;
   (E)  ANY APPROVED WHOLESALER SHALL AT ALL TIMES COMPLY WITH THE TRACK-
 ING AND TRACING REQUIREMENTS OF 21 U.S.C. §§ 360EEE AND 360EEE-1 TO  THE
 EXTENT  PRACTICABLE PRIOR TO IMPORTED PRESCRIPTION DRUGS COMING INTO THE
 POSSESSION OF THE APPROVED  WHOLESALER,  AND  FULLY  COMPLY  WITH  THOSE
 REQUIREMENTS  AFTER IMPORTED PRESCRIPTION DRUGS ARE IN THE POSSESSION OF
 THE APPROVED WHOLESALER;
   (F) AN APPROVED WHOLESALER SHALL  NOT  SELL,  DISTRIBUTE  OR  DISPENSE
 PRESCRIPTION DRUGS IMPORTED UNDER THE PROGRAM OUTSIDE OF THE STATE;
   (G) THE COMMISSIONER MAY IMPOSE AN ANNUAL FEE ON APPROVED WHOLESALERS,
 WHICH  MAY  BE  BASED  IN  WHOLE OR IN PART ON THE VALUE OF PRESCRIPTION
 DRUGS IMPORTED BY THE APPROVED WHOLESALER UNDER THE PROGRAM, TO  SUPPORT
 THE OPERATION OF THE PROGRAM;
   (H)  EVERY  APPROVED WHOLESALER SHALL PROVIDE THE COMMISSIONER AND THE
 COMMISSIONER OF EDUCATION WITH INFORMATION ON ITS PARTICIPATION  IN  THE
 PROGRAM AS REQUIRED BY SUCH COMMISSIONERS INCLUDING BUT NOT LIMITED TO:
   (I) THE NAME AND QUANTITY OF THE ACTIVE INGREDIENT OF THE DRUG;
   (II) A DESCRIPTION OF THE DOSAGE FORM OF THE DRUG;
   (III) THE DATE ON WHICH THE DRUG IS RECEIVED;
   (IV) THE QUANTITY OF THE DRUG THAT IS RECEIVED;
   (V) THE POINT OF ORIGIN AND DESTINATION OF THE DRUG; AND
   (VI) THE PRICE PAID BY THE APPROVED WHOLESALER FOR THE DRUG
   (I)  THE  COMMISSIONER  SHALL  PROVIDE  FOR  AUDITING  OF THE PROGRAM,
 INCLUDING MAKING SURE THAT PRESCRIPTION  DRUGS  ARE  MADE  AVAILABLE  AT
 SUBSTANTIAL  SAVINGS  TO  CONSUMERS AS A RESULT OF THE PROGRAM, ENSURING
 THAT THE PRESCRIPTION DRUGS ARE APPROVED FOR  MARKETING  IN  THE  UNITED
 STATES,  MEET ALL LABELING REQUIREMENTS UNDER STATE AND FEDERAL LAWS AND
 REGULATIONS, AND IS NOT ADULTERATED OR  MISBRANDED,  AND  ENSURING  THAT
 PRESCRIPTION DRUGS ARE AUTHENTIC AND IN COMPLIANCE WITH THE FEDERAL FOOD
 AND DRUG ADMINISTRATION'S APPROVED DRUG SPECIFICATIONS AND STANDARDS.
   3.  THE  DEPARTMENT,  IN CONSULTATION WITH THE STATE EDUCATION DEPART-
 MENT, SHALL PROMULGATE RULES AND REGULATIONS TO DESIGN  THE  PROGRAM  IN
 ACCORDANCE WITH SUBDIVISION TWO OF THIS SECTION.
   4.  (A)  THE  COMMISSIONER,  IN  CONSULTATION WITH THE COMMISSIONER OF
 EDUCATION, SHALL SEEK ALL NECESSARY APPROVALS AND CERTIFICATION  BY  THE
 SECRETARY  OF  THE  U.S.  DEPARTMENT OF HEALTH AND HUMAN SERVICES AND/OR
 OTHER APPROPRIATE  FEDERAL  OFFICIALS  OR  AGENCIES  FOR  THE  WHOLESALE
 PRESCRIPTION DRUG IMPORTATION PROGRAM DESIGNED UNDER THIS SECTION.
   (B)  THE  COMMISSIONER  SHALL  SEEK THE APPROPRIATE FEDERAL APPROVALS,
 WAIVERS, EXEMPTIONS, OR AGREEMENTS, OR A COMBINATION THEREOF, AS  NEEDED
 TO  ENABLE  ALL  COVERED  ENTITIES  ENROLLED IN OR ELIGIBLE FOR THE DRUG
 DISCOUNT PROGRAM AUTHORIZED BY SECTION 340B OF THE FEDERAL PUBLIC HEALTH
 SERVICE  ACT  (42  U.S.C.  §  256B)  TO  PARTICIPATE  IN  THE  WHOLESALE
 PRESCRIPTION  DRUG  IMPORTATION  PROGRAM  TO THE FULLEST EXTENT POSSIBLE
 WITHOUT JEOPARDIZING THEIR ELIGIBILITY FOR SUCH DRUG DISCOUNT PROGRAM.
 S. 9838                             3
 
   5. UPON RECEIPT OF FEDERAL APPROVAL AND CERTIFICATION UNDER  PARAGRAPH
 (A)  OF  SUBDIVISION FOUR OF THIS SECTION, THE COMMISSIONER SHALL IMPLE-
 MENT THE PROGRAM PURSUANT TO THIS SECTION.
   6.  THE  COMMISSIONER  SHALL  IMMEDIATELY SUSPEND THE IMPORTATION OF A
 SPECIFIC PRESCRIPTION DRUG OR THE IMPORTATION OF PRESCRIPTION  DRUGS  BY
 AN  APPROVED  WHOLESALER  IF THE COMMISSIONER DISCOVERS THAT ANY DRUG OR
 ACTIVITY IS IN VIOLATION OF THIS SECTION OR ANY FEDERAL OR STATE LAW  OR
 REGULATION,  AND  SHALL IMMEDIATELY NOTIFY THE COMMISSIONER OF EDUCATION
 OF SUCH SUSPENSION.   FURTHERMORE, THE  COMMISSIONER  SHALL  INFORM  THE
 COMMISSIONER OF EDUCATION OF ALL FACTS AND CIRCUMSTANCES LEADING TO SUCH
 SUSPENSION  AS SOON AS PRACTICABLE, AND SHALL COOPERATE WITH THE COMMIS-
 SIONER OF EDUCATION IN ANY DISCIPLINARY INVESTIGATION OR ACTION PURSUANT
 TO TITLE EIGHT OF THE EDUCATION LAW RELATED TO SUCH WHOLESALER.
   7. NOTHING IN THIS SECTION SHALL BE CONSTRUED AS AFFECTING OR  IN  ANY
 WAY INTERFERING WITH THE COMMISSIONER OF EDUCATION'S OVERSIGHT OF WHOLE-
 SALERS.
   8.  THE COMMISSIONER SHALL ANNUALLY REPORT TO THE GOVERNOR, THE TEMPO-
 RARY PRESIDENT OF THE SENATE, AND THE SPEAKER OF THE ASSEMBLY  REGARDING
 THE  IMPLEMENTATION  OF A FEDERALLY APPROVED WHOLESALE PRESCRIPTION DRUG
 IMPORTATION PROGRAM.  THE REPORT SHALL INCLUDE, AT A MINIMUM:
   (A) A LIST OF THE PRESCRIPTION DRUGS IMPORTED UNDER THE PROGRAM;
   (B) A LIST OF ALL PARTICIPATING CANADIAN PRESCRIPTION DRUG  SUPPLIERS,
 APPROVED WHOLESALERS, AND OTHER PARTICIPATING ENTITIES;
   (C) ESTIMATED COST SAVINGS DURING THE PREVIOUS FISCAL YEAR;
   (D) INFORMATION REGARDING AUDIT FINDINGS; AND
   (E) ANY OTHER RELEVANT INFORMATION.
   §  2.  Section  6808  of  the education law is amended by adding a new
 subdivision 10 to read as follows:
   10. PRESCRIPTION DRUG IMPORTATION PROGRAM WHOLESALERS. A. A WHOLESALER
 SHALL NOT PARTICIPATE IN THE  WHOLESALE  PRESCRIPTION  DRUG  IMPORTATION
 PROGRAM  UNDER  SECTION  TWO  HUNDRED  EIGHTY-D OF THE PUBLIC HEALTH LAW
 WITHOUT PRIOR APPLICATION AND APPROVAL BY THE DEPARTMENT.
   B. SUCH APPLICATION SHALL BE MADE ON A FORM PRESCRIBED BY THE  DEPART-
 MENT.
   C.  SUCH  APPLICATION  SHALL BE ACCOMPANIED BY A FEE DETERMINED BY THE
 DEPARTMENT.
   D. ALL APPROVALS SHALL BE RENEWED ON DATES SET BY THE DEPARTMENT.
   E. ALL APPROVALS SHALL MEET APPLICABLE FEDERAL  LAWS  AND  REGULATIONS
 INCLUDING UNDER 21 U.S.C. § 384, AS AMENDED, AND ANY REGULATIONS PROMUL-
 GATED THEREUNDER.
   §  3.  This  act shall take effect eighteen months after it shall have
 become a law. Effective  immediately,  the  addition,  amendment  and/or
 repeal  of  any  rule  or regulation necessary for the implementation of
 this act on its effective date are authorized to be made  and  completed
 on or before such effective date.

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Senate Bill S9838

Sponsored By

Current Bill Status - On Floor Calendar

Jun 6, 2024 - Floor Vote

Floor Vote: Jun 6, 2024

2023-S9838 (ACTIVE) - Details

2023-S9838 (ACTIVE) - Summary

2023-S9838 (ACTIVE) - Sponsor Memo

2023-S9838 (ACTIVE) - Bill Text download pdf

Comments

Senate Bill S9838

Share this bill

Sponsored By

James Skoufis

Current Bill Status - On Floor Calendar

2023-S9838 (ACTIVE) - Details

2023-S9838 (ACTIVE) - Summary

2023-S9838 (ACTIVE) - Sponsor Memo

2023-S9838 (ACTIVE) - Bill Text download pdf

Comments