What's happening
The bill creates a wholesale prescription drug importation program in New York to allow approved wholesalers to import certain drugs, aiming to increase consumer savings and ensure safety compliance.
Why it matters
Focuses on Consumer Savings. The program is designed to allow only those drugs expected to generate substantial savings for consumers to be imported, meaning it targets reducing out-of-pocket costs for New Yorkers rather than simply expanding supply.
Emphasizes Safety and Compliance. Strict safeguards are included, such as importing drugs only from regulated suppliers, ensuring all products meet FDA safety and efficacy standards, and requiring adherence to federal tracking and tracing protocols, which helps address public concerns about counterfeit or unsafe medicines.
Includes Oversight and Accountability Mechanisms. The bill requires regular audits, reporting to the legislature, and information sharing by participating wholesalers, as well as confidentiality provisions when necessary. This aims to ensure that the program truly delivers savings and operates transparently.
Addresses Market Competition and Existing Drug Programs. The commissioner must coordinate with the Attorney General to monitor for anticompetitive behavior, and seek federal waivers to ensure that entities participating in the federal 340B drug pricing program can benefit from the importation program without risking their eligibility, integrating the new program with existing cost-saving measures.
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Who cares
Headline styles
Import Cheaper Prescription Drugs
Plain English, a few words. Used as the page title.
Sponsors
Senator · Senate District 39
History
- Referred to health
- Referred to health
Companion bill
The same bill in the other chamber. A bill becomes law when one version passes both houses and the governor signs it, so either number can carry it.
Import Cheaper Prescription Drugs
In Assembly Committee · Higher Education · Sponsor Richard Gottfried
Full text
2 pagesUnderlined is new[Struck] is removedOfficial text on nysenate.gov ↗
STATE OF NEW YORK
5682
2019-2020 Regular Sessions
IN SENATE
May 10, 2019
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, in relation to creating a wholesale prescription drug importation program
The People of the State of New York, represented in Senate and Assembly, 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 officials. 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.
LBD11421-01-9
S. 5682 2
(ii) prescription drugs shall only be acquired from suppliers regulated and authorized under the laws of the other country or a jurisdiction thereof;
(iii) only prescription drugs meeting the U.S. Food and Drug Administration'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 tracking 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 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;
(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 necessary 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 identify 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 certification 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 jeopardizing 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 reasonable 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.
Reflowed for reading: line numbers and page breaks removed. Cite the official text.
Sponsor's memo
Title of bill
An act to amend the public health 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
New bill
Fiscal implications
None.
Effective date
Immediately
Summaries, headlines and scores are AI-generated from the official bill text. How we score bills. Source: NYS Open Legislation.