Bill Text: NY S00604 | 2023-2024 | General Assembly | Introduced
Bill Title: Creates a wholesale prescription drug importation program which complies with federal standards and regulations for the purpose of generating substantial savings for consumers.
Spectrum: Partisan Bill (Democrat 12-0)
Status: (Engrossed) 2024-06-03 - referred to higher education [S00604 Detail]
Download: New_York-2023-S00604-Introduced.html
STATE OF NEW YORK ________________________________________________________________________ 604 2023-2024 Regular Sessions IN SENATE January 5, 2023 ___________ Introduced by Sens. SKOUFIS, FELDER, HOYLMAN, JACKSON, MAY, MYRIE, SERRANO, 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: 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: 21 (i) the commissioner shall approve one or more prescription drug 22 wholesalers to seek federal certification and approval to import 23 prescription drugs from one or more other countries, to be sold or 24 distributed wholesale in the state; EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD03404-01-3S. 604 2 1 (ii) prescription drugs shall only be acquired from suppliers regu- 2 lated and authorized under the laws of the other country or a jurisdic- 3 tion thereof; 4 (iii) only prescription drugs meeting the U.S. Food and Drug Adminis- 5 tration's safety, effectiveness, and other standards shall be imported 6 under the program; 7 (iv) only prescription drugs expected to generate substantial savings 8 for consumers shall be imported; 9 (v) the approved wholesaler shall at all times comply with the track- 10 ing and tracing requirements of 21 U.S.C. §§ 360eee and 360eee-1 to the 11 extent feasible and practical, including prior to imported prescription 12 drugs coming into its possession; 13 (vi) an approved wholesaler shall not sell or distribute prescription 14 drugs imported under the program outside the state; 15 (vii) the commissioner may impose an annual fee on approved whole- 16 salers, which may be based in whole or in part on the value of 17 prescription drugs imported by the approved wholesaler under the 18 program, to support the operation of the program; 19 (viii) every approved wholesaler shall provide the commissioner with 20 information on its participation in the program as reasonably required 21 by the commissioner; the commissioner may provide for keeping certain 22 information confidential within the department where reasonably neces- 23 sary for successful operation of the program; and 24 (ix) the commissioner shall provide for auditing of the program, 25 including making sure that prescription drugs are made available at 26 substantial savings to consumers as a result of the program. 27 (d) The commissioner shall make regulations and take other actions 28 reasonably necessary to implement the program. 29 2. The commissioner shall consult with the attorney general to identi- 30 fy the potential for, and to monitor, anticompetitive behavior under or 31 in relation to the program. 32 3. (a) The commissioner shall seek all necessary approvals and certif- 33 ication by the secretary of the U.S. Department of Health and Human 34 Services or other appropriate federal officials or agencies for the 35 wholesale prescription drug importation program. 36 (b) The commissioner shall seek the appropriate federal approvals, 37 waivers, exemptions, or agreements, or a combination thereof, as needed 38 to enable all covered entities enrolled in or eligible for the federal 39 340B drug pricing program to participate in the wholesale prescription 40 drug importation program to the fullest extent possible without jeopard- 41 izing their eligibility for the 340B program. 42 4. The commissioner shall establish procedures for prescription drug 43 wholesalers to apply and be approved to be an approved wholesaler, 44 including requirements for periodic renewal of that approval. The 45 commissioner shall provide reasonable grounds for suspending or revoking 46 approval of an approved wholesaler under this section, including reason- 47 able provision for notice, opportunity to be heard, and appeal. 48 5. The commissioner shall annually report to the assembly committees 49 on health and on ways and means and the senate committees on health and 50 on finance regarding the operation of the wholesale prescription drug 51 importation program. 52 § 2. This act shall take effect immediately.
