NY State Senate Bill 2025-S371

Current Bill Status - In Senate Committee Health Committee

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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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 08, 2025	referred to health

2025-S371 (ACTIVE) - Details

Current Committee:: Senate Health
Law Section:: Public Health Law
Laws Affected:: Add §280-d, Pub Health L; amd §6808, Ed L
Versions Introduced in 2023-2024 Legislative Session:: S9838

2025-S371 (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.

2025-S371 (ACTIVE) - Sponsor Memo

                                 
BILL NUMBER: S371

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:

Creates a wholesale prescription drug importation program that complies
with federal standards and regulations, generating substantial consumer
savings.

 
SUMMARY OF PROVISIONS:

Section 1: 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 promulgates regulations in consultation with the
State Education Department and reports annually to the legislature.

Section 2: 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 3: Sets the effective date.

 
JUSTIFICATION:

Concern about drug pricing is at an all-time high. Studies show how the
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. Still, 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 federal law, shipments from Canada, for example, will be tested on
a sample basis for purity and potency. Products would be appropriately
labeled for the U.S. market and distributed to retail pharmacies and
other settings included in the program. 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 prod-
uct acquisition cost will be the Canadian price. Pharmacies and other
dispensers will charge the Canadian price without markup, except for
cost-based dispensing fees 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 markup, except for the 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:

Senate

2019: S5682, Referred to Health

2020: S5682, Referred to Health

2021: S1737, Referred to Health

2022: S1737, Passed Senate

2023: N/A

2024: S604, Passed Senate

Assembly

2019: A7588, Referred to Higher Education

2020: A7588, Referred to Higher Education

2021: A133, Referred to Higher Education

2022: A133, Referred to Higher Education

2023: No Assembly Same As

2024: No Assembly Same As

 
FISCAL IMPLICATIONS:

None.

 
EFFECTIVE DATE:
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.

2025-S371 (ACTIVE) - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                    371
 
                        2025-2026 Regular Sessions
 
                             I N  S E N A T E
 
                                (PREFILED)
 
                              January 8, 2025
                                ___________
 
 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 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;
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.

                                                            LBD00949-01-5
 S. 371                              2
 
   (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;
   (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
 S. 371                              3
 
 PRESCRIPTION DRUG IMPORTATION PROGRAM TO  THE  FULLEST  EXTENT  POSSIBLE
 WITHOUT JEOPARDIZING THEIR ELIGIBILITY FOR SUCH DRUG DISCOUNT PROGRAM.
   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 S371

Sponsored By

Current Bill Status - In Senate Committee Health Committee

2025-S371 (ACTIVE) - Details

2025-S371 (ACTIVE) - Summary

2025-S371 (ACTIVE) - Sponsor Memo

2025-S371 (ACTIVE) - Bill Text download pdf

Comments

Senate Bill S371

Share this bill

Sponsored By

James Skoufis

Current Bill Status - In Senate Committee Health Committee

2025-S371 (ACTIVE) - Details

2025-S371 (ACTIVE) - Summary

2025-S371 (ACTIVE) - Sponsor Memo

2025-S371 (ACTIVE) - Bill Text download pdf

Comments