Creates a wholesale prescription drug importation program which complies with federal standards and regulations for the purpose of generating substantial savings for consumers.
NEW YORK STATE ASSEMBLY MEMORANDUM IN SUPPORT OF LEGISLATION submitted in accordance with Assembly Rule III, Sec 1(f)
BILL NUMBER: A4604
SPONSOR: Simon (MS) 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:
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:
2023-24: A7954a Simon S9838 Skoufis -referred to health
Senate
2020 - S5682, Referred to Health
2021-2022- S1737, Passed Senate Assembly
2020 - A7588 Referred to Higher Education
2021-2022- A133, Referred to Higher Education
FISCAL IMPLICATIONS:
none
EFFECTIVE DATE:
This act shall take effect immediately.
STATE OF NEW YORK
________________________________________________________________________
4604
2025-2026 Regular Sessions
IN ASSEMBLY
February 4, 2025
___________
Introduced by M. of A. SIMON, COOK, DINOWITZ, HUNTER, MAGNARELLI, RAMOS,
RIVERA, ROSENTHAL, REYES, CRUZ, EPSTEIN, COLTON, PAULIN, GONZALEZ-RO-
JAS, SMITH, FORREST, JACKSON, SIMONE, HEVESI, LUNSFORD, LEVENBERG,
SANTABARBARA, LUPARDO, DeSTEFANO, DAVILA, CLARK, BURDICK, STECK,
SHRESTHA, SEAWRIGHT, K. BROWN, SHIMSKY, PHEFFER AMATO, BORES, McDO-
NOUGH -- Multi-Sponsored by -- M. of A. BUTTENSCHON -- read once and
referred to the Committee on Ways and Means
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:
1 Section 1. The public health law is amended by adding a new section
2 280-d to read as follows:
3 § 280-d. Wholesale prescription drug importation program. 1. As used
4 in this section, the following terms shall have the following meanings:
5 (a) "Wholesale prescription drug importation program" or "program"
6 means the wholesale prescription drug importation program created under
7 this section.
8 (b) "Prescription drug wholesaler" means an entity authorized to
9 acquire prescription drugs and sell or distribute them wholesale in the
10 state.
11 (c) "Approved wholesaler" means a prescription drug wholesaler author-
12 ized to participate in the importation program under this section pursu-
13 ant to approval by the state education department under section sixty-
14 eight hundred eight of the education law.
15 2. The commissioner, in consultation with the commissioner of educa-
16 tion and other appropriate federal and state agencies, shall design a
17 wholesale prescription drug importation program for the wholesale impor-
18 tation of prescription drugs from Canada. The program design shall
19 comply with applicable federal requirements, including 21 U.S.C. § 384,
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD00949-01-5
A. 4604 2
1 and requirements regarding safety and cost savings. Under the program
2 design:
3 (a) prescription drugs shall only be acquired from Canadian
4 prescription drug suppliers regulated and authorized under the laws of
5 Canada or one or more Canadian provinces, or both;
6 (b) only prescription drugs meeting the federal Food and Drug Adminis-
7 tration's safety, effectiveness, misbranding, adulteration and other
8 standards shall be imported under the program;
9 (c) only prescription drugs expected to generate substantial savings
10 for consumers in the state shall be imported;
11 (d) the prescription drug is not:
12 (i) a controlled substance as defined in 21 U.S.C. § 802;
13 (ii) a biological product as defined in 42 U.S.C. § 262;
14 (iii) an infused drug, including a peritoneal dialysis solution;
15 (iv) an intravenously injected drug;
16 (v) a drug that is inhaled during surgery;
17 (vi) a drug which is a parenteral drug, the importation of which is
18 determined by the United States Secretary of Health and Human Services
19 to pose a threat to public health;
20 (e) any approved wholesaler shall at all times comply with the track-
21 ing and tracing requirements of 21 U.S.C. §§ 360eee and 360eee-1 to the
22 extent practicable prior to imported prescription drugs coming into the
23 possession of the approved wholesaler, and fully comply with those
24 requirements after imported prescription drugs are in the possession of
25 the approved wholesaler;
26 (f) an approved wholesaler shall not sell, distribute or dispense
27 prescription drugs imported under the program outside of the state;
28 (g) the commissioner may impose an annual fee on approved wholesalers,
29 which may be based in whole or in part on the value of prescription
30 drugs imported by the approved wholesaler under the program, to support
31 the operation of the program;
32 (h) every approved wholesaler shall provide the commissioner and the
33 commissioner of education with information on its participation in the
34 program as required by such commissioners including but not limited to:
35 (i) the name and quantity of the active ingredient of the drug;
36 (ii) a description of the dosage form of the drug;
37 (iii) the date on which the drug is received;
38 (iv) the quantity of the drug that is received;
39 (v) the point of origin and destination of the drug; and
40 (vi) the price paid by the approved wholesaler for the drug
41 (i) the commissioner shall provide for auditing of the program,
42 including making sure that prescription drugs are made available at
43 substantial savings to consumers as a result of the program, ensuring
44 that the prescription drugs are approved for marketing in the United
45 States, meet all labeling requirements under state and federal laws and
46 regulations, and is not adulterated or misbranded, and ensuring that
47 prescription drugs are authentic and in compliance with the federal Food
48 and Drug Administration's approved drug specifications and standards.
49 3. The department, in consultation with the state education depart-
50 ment, shall promulgate rules and regulations to design the program in
51 accordance with subdivision two of this section.
52 4. (a) The commissioner, in consultation with the commissioner of
53 education, shall seek all necessary approvals and certification by the
54 secretary of the U.S. Department of Health and Human Services and/or
55 other appropriate federal officials or agencies for the wholesale
56 prescription drug importation program designed under this section.
A. 4604 3
1 (b) The commissioner shall seek the appropriate federal approvals,
2 waivers, exemptions, or agreements, or a combination thereof, as needed
3 to enable all covered entities enrolled in or eligible for the drug
4 discount program authorized by section 340B of the federal public health
5 service act (42 U.S.C. § 256b) to participate in the wholesale
6 prescription drug importation program to the fullest extent possible
7 without jeopardizing their eligibility for such drug discount program.
8 5. Upon receipt of federal approval and certification under paragraph
9 (a) of subdivision four of this section, the commissioner shall imple-
10 ment the program pursuant to this section.
11 6. The commissioner shall immediately suspend the importation of a
12 specific prescription drug or the importation of prescription drugs by
13 an approved wholesaler if the commissioner discovers that any drug or
14 activity is in violation of this section or any federal or state law or
15 regulation, and shall immediately notify the commissioner of education
16 of such suspension. Furthermore, the commissioner shall inform the
17 commissioner of education of all facts and circumstances leading to such
18 suspension as soon as practicable, and shall cooperate with the commis-
19 sioner of education in any disciplinary investigation or action pursuant
20 to title eight of the education law related to such wholesaler.
21 7. Nothing in this section shall be construed as affecting or in any
22 way interfering with the commissioner of education's oversight of whole-
23 salers.
24 8. The commissioner shall annually report to the governor, the tempo-
25 rary president of the senate, and the speaker of the assembly regarding
26 the implementation of a federally approved wholesale prescription drug
27 importation program. The report shall include, at a minimum:
28 (a) a list of the prescription drugs imported under the program;
29 (b) a list of all participating Canadian prescription drug suppliers,
30 approved wholesalers, and other participating entities;
31 (c) estimated cost savings during the previous fiscal year;
32 (d) information regarding audit findings; and
33 (e) any other relevant information.
34 § 2. Section 6808 of the education law is amended by adding a new
35 subdivision 10 to read as follows:
36 10. Prescription drug importation program wholesalers. a. A wholesaler
37 shall not participate in the wholesale prescription drug importation
38 program under section two hundred eighty-d of the public health law
39 without prior application and approval by the department.
40 b. Such application shall be made on a form prescribed by the depart-
41 ment.
42 c. Such application shall be accompanied by a fee determined by the
43 department.
44 d. All approvals shall be renewed on dates set by the department.
45 e. All approvals shall meet applicable federal laws and regulations
46 including under 21 U.S.C. § 384, as amended, and any regulations promul-
47 gated thereunder.
48 § 3. This act shall take effect eighteen months after it shall have
49 become a law. Effective immediately, the addition, amendment and/or
50 repeal of any rule or regulation necessary for the implementation of
51 this act on its effective date are authorized to be made and completed
52 on or before such effective date.
