NY State Senate Bill S1737

Archive: Last Bill Status - Passed Senate

Introduced
In Committee
On Floor Calendar
- Passed Senate
- Passed Assembly
Delivered to Governor
Signed/Vetoed by Governor

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Actions

view actions (8)

	Assembly Actions - Lowercase Senate Actions - UPPERCASE
May 24, 2022	referred to higher education delivered to assembly passed senate
May 23, 2022	ordered to third reading cal.1421
May 17, 2022	reported and committed to rules
May 11, 2022	reported and committed to finance
Jan 05, 2022	referred to health
Jan 14, 2021	referred to health

Votes

view votes

May 24, 2022 - floor Vote

S1737

floor

Aye

Nay

Absent

Excused

Abstained

May 23, 2022 - Rules committee Vote

S1737

committee

Aye

Nay

Aye with Reservations

Absent

Excused

Abstained

May 17, 2022 - Finance committee Vote

S1737

committee

Aye

Nay

Aye with Reservations

Absent

Excused

Abstained

May 9, 2022 - Health committee Vote

S1737

committee

Aye

Nay

Aye with Reservations

Absent

Excused

Abstained

show Health committee vote details

Health Committee Vote: May 9, 2022

aye (10)

nay (3)

aye wr (1)

Boyle

excused (1)

Brouk

Co-Sponsors

view additional co-sponsors

S1737 (ACTIVE) - Details

See Assembly Version of this Bill:: A133
Current Committee:: Assembly Higher Education
Law Section:: Public Health Law
Laws Affected:: Add Art 2-A Title 2 §280-d, Pub Health L
Versions Introduced in Other Legislative Sessions:: 2019-2020: S5682, A7588
2023-2024: S604

S1737 (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.

S1737 (ACTIVE) - Sponsor Memo

 
BILL NUMBER: S1737

SPONSOR: SKOUFIS
 
TITLE OF BILL:

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

 
PURPOSE:

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

 
SUMMARY OF 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 distrib-
ution 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.

 
LEGISLATIVE HISTORY:

2020 - S5682 Referred to Health

Assembly

2020 - A7588 Referred to Higher Education

 
FISCAL IMPLICATIONS:

None.

 
EFFECTIVE DATE:
Immediately

S1737 (ACTIVE) - Bill Text download pdf

 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   1737
 
                        2021-2022 Regular Sessions
 
                             I N  S E N A T E
 
                             January 14, 2021
                                ___________
 
 Introduced  by  Sens. SKOUFIS, BENJAMIN, BIAGGI, FELDER, GAUGHRAN, HOYL-
   MAN, JACKSON, MAY, MYRIE, THOMAS -- 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:
 
   Section  1. Title 2 of article 2-A of 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.  (A)
 THERE  IS HEREBY CREATED IN THE DEPARTMENT A WHOLESALE PRESCRIPTION DRUG
 IMPORTATION PROGRAM.
   (B) AS USED IN THIS  SECTION,  UNLESS  THE  CONTEXT  CLEARLY  REQUIRES
 OTHERWISE, THE FOLLOWING TERMS SHALL HAVE THE FOLLOWING MEANINGS:
   (I)  "WHOLESALE  PRESCRIPTION  DRUG  IMPORTATION PROGRAM" OR "PROGRAM"
 MEANS THE WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM CREATED  UNDER
 THIS SECTION.
   (II)  "PRESCRIPTION  DRUG  WHOLESALER"  MEANS  AN ENTITY AUTHORIZED TO
 ACQUIRE PRESCRIPTION DRUGS AND SELL OR DISTRIBUTE THEM WHOLESALE IN  THE
 STATE.
   (III)  "APPROVED  WHOLESALER"  MEANS  A  PRESCRIPTION  DRUG WHOLESALER
 APPROVED UNDER THIS SECTION TO PARTICIPATE IN THE PROGRAM.
   (C) THE COMMISSIONER  SHALL  DEVELOP  AND  IMPLEMENT  THE  PROGRAM  IN
 CONSULTATION  WITH INTERESTED STAKEHOLDERS AND APPROPRIATE FEDERAL OFFI-
 CIALS. THE PROGRAM SHALL COMPLY WITH  APPLICABLE  FEDERAL  REQUIREMENTS,
 INCLUDING  21  U.S.C.  § 384, AND REQUIREMENTS REGARDING SAFETY AND COST
 SAVINGS. UNDER THE PROGRAM:
   (I) THE COMMISSIONER SHALL  APPROVE  ONE  OR  MORE  PRESCRIPTION  DRUG
 WHOLESALERS  TO  SEEK  FEDERAL  CERTIFICATION  AND  APPROVAL  TO  IMPORT
 PRESCRIPTION DRUGS FROM ONE OR MORE  OTHER  COUNTRIES,  TO  BE  SOLD  OR
 DISTRIBUTED WHOLESALE IN THE STATE;
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.

                                                            LBD00370-01-1

 S. 1737                             2
 
   (II)  PRESCRIPTION  DRUGS  SHALL ONLY BE ACQUIRED FROM SUPPLIERS REGU-
 LATED AND AUTHORIZED UNDER THE LAWS OF THE OTHER COUNTRY OR A  JURISDIC-
 TION THEREOF;
   (III)  ONLY PRESCRIPTION DRUGS MEETING THE U.S. FOOD AND DRUG ADMINIS-
 TRATION'S SAFETY, EFFECTIVENESS, AND OTHER STANDARDS SHALL  BE  IMPORTED
 UNDER THE PROGRAM;
   (IV)  ONLY PRESCRIPTION DRUGS EXPECTED TO GENERATE SUBSTANTIAL SAVINGS
 FOR CONSUMERS SHALL BE IMPORTED;
   (V) THE 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 FEASIBLE AND PRACTICAL, INCLUDING PRIOR TO IMPORTED  PRESCRIPTION
 DRUGS COMING INTO ITS POSSESSION;
   (VI)  AN APPROVED WHOLESALER SHALL NOT SELL OR DISTRIBUTE PRESCRIPTION
 DRUGS IMPORTED UNDER THE PROGRAM OUTSIDE THE STATE;
   (VII) THE COMMISSIONER MAY IMPOSE AN ANNUAL  FEE  ON  APPROVED  WHOLE-
 SALERS,  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;
   (VIII)  EVERY  APPROVED WHOLESALER SHALL PROVIDE THE COMMISSIONER WITH
 INFORMATION ON ITS PARTICIPATION IN THE PROGRAM AS  REASONABLY  REQUIRED
 BY  THE  COMMISSIONER;  THE COMMISSIONER MAY PROVIDE FOR KEEPING CERTAIN
 INFORMATION CONFIDENTIAL WITHIN THE DEPARTMENT WHERE  REASONABLY  NECES-
 SARY FOR SUCCESSFUL OPERATION OF THE PROGRAM; AND
   (IX)  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.
   (D)  THE  COMMISSIONER  SHALL  MAKE REGULATIONS AND TAKE OTHER ACTIONS
 REASONABLY NECESSARY TO IMPLEMENT THE PROGRAM.
   2. THE COMMISSIONER SHALL CONSULT WITH THE ATTORNEY GENERAL TO IDENTI-
 FY THE POTENTIAL FOR, AND TO MONITOR, ANTICOMPETITIVE BEHAVIOR UNDER  OR
 IN RELATION TO THE PROGRAM.
   3. (A) THE COMMISSIONER SHALL SEEK ALL NECESSARY APPROVALS AND CERTIF-
 ICATION  BY  THE  SECRETARY  OF  THE U.S. DEPARTMENT OF HEALTH AND HUMAN
 SERVICES OR OTHER APPROPRIATE FEDERAL  OFFICIALS  OR  AGENCIES  FOR  THE
 WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM.
   (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 FEDERAL
 340B DRUG PRICING PROGRAM TO PARTICIPATE IN THE  WHOLESALE  PRESCRIPTION
 DRUG IMPORTATION PROGRAM TO THE FULLEST EXTENT POSSIBLE WITHOUT JEOPARD-
 IZING THEIR ELIGIBILITY FOR THE 340B PROGRAM.
   4.  THE  COMMISSIONER SHALL ESTABLISH PROCEDURES FOR PRESCRIPTION DRUG
 WHOLESALERS TO APPLY AND BE  APPROVED  TO  BE  AN  APPROVED  WHOLESALER,
 INCLUDING  REQUIREMENTS  FOR  PERIODIC  RENEWAL  OF  THAT  APPROVAL. THE
 COMMISSIONER SHALL PROVIDE REASONABLE GROUNDS FOR SUSPENDING OR REVOKING
 APPROVAL OF AN APPROVED WHOLESALER UNDER THIS SECTION, INCLUDING REASON-
 ABLE PROVISION FOR NOTICE, OPPORTUNITY TO BE HEARD, AND APPEAL.
   5. THE COMMISSIONER SHALL ANNUALLY REPORT TO THE  ASSEMBLY  COMMITTEES
 ON  HEALTH AND ON WAYS AND MEANS AND THE SENATE COMMITTEES ON HEALTH AND
 ON FINANCE REGARDING THE OPERATION OF THE  WHOLESALE  PRESCRIPTION  DRUG
 IMPORTATION PROGRAM.
   § 2. This act shall take effect immediately.

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The New York State Senate

senate Bill S1737

Sponsored By

Archive: Last Bill Status - Passed Senate

Your Voice

Actions

Votes

May 24, 2022 - floor Vote

Floor Vote: May 24, 2022

May 23, 2022 - Rules committee Vote

Rules Committee Vote: May 23, 2022

May 17, 2022 - Finance committee Vote

Finance Committee Vote: May 17, 2022

May 9, 2022 - Health committee Vote

Health Committee Vote: May 9, 2022

Co-Sponsors

S1737 (ACTIVE) - Details

S1737 (ACTIVE) - Summary

S1737 (ACTIVE) - Sponsor Memo

S1737 (ACTIVE) - Bill Text download pdf

Comments

senate Bill S1737

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Sponsored By

Archive: Last Bill Status - Passed Senate

Your Voice

Actions

Votes

May 24, 2022 - floor Vote

Floor Vote: May 24, 2022

May 23, 2022 - Rules committee Vote

Rules Committee Vote: May 23, 2022

May 17, 2022 - Finance committee Vote

Finance Committee Vote: May 17, 2022

May 9, 2022 - Health committee Vote

Health Committee Vote: May 9, 2022

Co-Sponsors

S1737 (ACTIVE) - Details

S1737 (ACTIVE) - Summary

S1737 (ACTIVE) - Sponsor Memo

S1737 (ACTIVE) - Bill Text download pdf

Comments