What's happening
This bill creates a state-run lab to develop and produce affordable generic drugs, starting with biosimilar insulin, and limits insulin costs for New Yorkers.
Why it matters
Establishes a public drug manufacturing capability within the SUNY system. , aiming to increase competition and directly address drug shortages, which could make essential medicines more reliably available and less vulnerable to supply chain disruptions or market manipulation.
Ties the price of state-produced generic drugs (including insulin) to actual production costs or a capped rate. , meaning New Yorkers would be shielded from price spikes and profiteering on critical drugs—potentially saving patients and insurers significant money.
Prioritizes drugs with the greatest public health impact or those subject to high costs and shortages. , focusing state resources on medicines where intervention can most effectively reduce health inequities and financial burdens.
Requires the state to act quickly by forming partnerships with nonprofit manufacturers until its own facility is operational. , ensuring that lower-cost insulin becomes available to residents as soon as possible, rather than waiting for the new lab to be built and certified.
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Who cares
Headline styles
Make Generic Insulin in NY
Plain English, a few words. Used as the page title.
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History
- Referred to health
- Referred to health
Full text
2 pagesUnderlined is new[Struck] is removedOfficial text on nysenate.gov ↗
STATE OF NEW YORK
500
2025-2026 Regular Sessions
IN ASSEMBLY (Prefiled)
January 8, 2025
Introduced by M. of A. STECK -- read once and referred to the Committee on Health
AN ACT to amend the public health law, in relation to establishing a generic drug research and development laboratory and production facility and the empire state biosimilar insulin initiative
The People of the State of New York, represented in Senate and Assembly, do enact as follows:
Section 1. Article 2-A of the public health law is amended by adding a new title IV to read as follows:
TITLE IV
NEW YORK AFFORDABLE DRUG MANUFACTURING ACT Section 285. Definitions.
286. Generic drug research and development laboratory and
production facility; empire state biosimilar insulin
initiative.
287. Partnerships; production and distribution of prescription
drugs.
288. Proprietary information.
§ 285. Definitions. 1. For the purposes of this title, the following terms shall have the following meanings:
(a) "Generic drug" shall mean a drug that is approved pursuant to subdivision (j) of section 355 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.), or a biosimilar, as defined under the federal Public Health Service Act (42 U.S.C. Sec. 262).
(b) "Partnerships" shall include, but not be limited to, agreements for the procurement of generic prescription drugs by way of contracts or purchasing by a payer, state governmental agency, group purchasing organization, nonprofit organization, or other entity.
§ 286. Generic drug research and development laboratory and production facility; empire state biosimilar insulin initiative. 1. (a) The depart-
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD00670-01-5
ment shall establish a generic drug research and development laboratory and production facility within the university of the state of New York system.
(b) The generic drug research and development laboratory and production facility established pursuant to paragraph (a) of this subdivision shall produce and distribute generic prescription drugs, with the intent that these drugs be made widely available to public and private purchasers, facilities licensed pursuant to article twenty-eight of this chapter, and pharmacies as defined in section six thousand eight hundred two of the education law, as appropriate.
(c) Each drug produced pursuant to paragraph (b) of this subdivision shall be made available to providers, patients, and purchasers at a price not to exceed the cost of such production for residents of the state.
(d) The department shall prioritize the development and production of generic prescription drugs that have the greatest impact on lowering drug costs to patients, increasing competition and addressing shortages in the prescription drug market, improving public health, or reducing the cost of prescription drugs to public and private purchasers.
2. The first initiative of the generic drug research and development laboratory and production facility established pursuant to subdivision one of this section shall be the empire state biosimilar insulin initiative. Such initiative shall include the research, development, and production of generic forms of the three most widely used forms of insulin. Such insulin shall be produced or distributed by a non-profit generic drug manufacturer that is registered with the United States Food and Drug Administration.
3. Until such time as the generic drug research and development laboratory and production facility is completed and the empire state biosimilar insulin initiative begins, the commissioner shall enter into partnerships resulting in the production or distribution of at least one generic form of insulin pursuant to section two hundred eighty-seven of this title.
§ 287. Partnerships; production and distribution of prescription drugs. 1. The commissioner shall enter into partnerships resulting in the production or distribution of at least one generic form of insulin, with the intent that such insulin be made widely available to public and private purchasers, facilities licensed pursuant to article twenty-eight of this chapter, and pharmacies as defined in section six thousand eight hundred two of the education law, as appropriate. Such insulin shall be produced or distributed by a non-profit generic drug manufacturer that is registered with the United States Food and Drug Administration.
2. Each form of insulin produced pursuant to subdivision one of this section shall be made available to providers, patients, and purchasers at a price not to exceed thirty dollars per monthly dose for residents of the state.
§ 288. Proprietary information. Notwithstanding any provision of law to the contrary, all nonpublic information and documents obtained by the department pursuant to this title shall not be required to be disclosed pursuant to article six of the public officers law.
§ 2. This act shall take effect immediately.
Reflowed for reading: line numbers and page breaks removed. Cite the official text.
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