New York Assembly Bill A00500 Latest Draft

   
  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 facil- ity and the empire state biosimilar insulin initiative The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. Article 2-A of the public health law is amended by adding a 2 new title IV to read as follows: 3 TITLE IV 4 NEW YORK AFFORDABLE DRUG MANUFACTURING ACT 5 Section 285. Definitions. 6 286. Generic drug research and development laboratory and 7 production facility; empire state biosimilar insulin 8 initiative. 9 287. Partnerships; production and distribution of prescription 10 drugs. 11 288. Proprietary information. 12 § 285. Definitions. 1. For the purposes of this title, the following 13 terms shall have the following meanings: 14 (a) "Generic drug" shall mean a drug that is approved pursuant to 15 subdivision (j) of section 355 of the Federal Food, Drug, and Cosmetic 16 Act (21 U.S.C. Sec. 301 et seq.), or a biosimilar, as defined under the 17 federal Public Health Service Act (42 U.S.C. Sec. 262). 18 (b) "Partnerships" shall include, but not be limited to, agreements 19 for the procurement of generic prescription drugs by way of contracts or 20 purchasing by a payer, state governmental agency, group purchasing 21 organization, nonprofit organization, or other entity. 22 § 286. Generic drug research and development laboratory and production 23 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 
 A. 500 2 1 ment shall establish a generic drug research and development laboratory 2 and production facility within the university of the state of New York 3 system. 4 (b) The generic drug research and development laboratory and 5 production facility established pursuant to paragraph (a) of this subdi- 6 vision shall produce and distribute generic prescription drugs, with the 7 intent that these drugs be made widely available to public and private 8 purchasers, facilities licensed pursuant to article twenty-eight of this 9 chapter, and pharmacies as defined in section six thousand eight hundred 10 two of the education law, as appropriate. 11 (c) Each drug produced pursuant to paragraph (b) of this subdivision 12 shall be made available to providers, patients, and purchasers at a 13 price not to exceed the cost of such production for residents of the 14 state. 15 (d) The department shall prioritize the development and production of 16 generic prescription drugs that have the greatest impact on lowering 17 drug costs to patients, increasing competition and addressing shortages 18 in the prescription drug market, improving public health, or reducing 19 the cost of prescription drugs to public and private purchasers. 20 2. The first initiative of the generic drug research and development 21 laboratory and production facility established pursuant to subdivision 22 one of this section shall be the empire state biosimilar insulin initi- 23 ative. Such initiative shall include the research, development, and 24 production of generic forms of the three most widely used forms of insu- 25 lin. Such insulin shall be produced or distributed by a non-profit 26 generic drug manufacturer that is registered with the United States Food 27 and Drug Administration. 28 3. Until such time as the generic drug research and development labo- 29 ratory and production facility is completed and the empire state biosi- 30 milar insulin initiative begins, the commissioner shall enter into part- 31 nerships resulting in the production or distribution of at least one 32 generic form of insulin pursuant to section two hundred eighty-seven of 33 this title. 34 § 287. Partnerships; production and distribution of prescription 35 drugs. 1. The commissioner shall enter into partnerships resulting in 36 the production or distribution of at least one generic form of insulin, 37 with the intent that such insulin be made widely available to public and 38 private purchasers, facilities licensed pursuant to article twenty-eight 39 of this chapter, and pharmacies as defined in section six thousand eight 40 hundred two of the education law, as appropriate. Such insulin shall be 41 produced or distributed by a non-profit generic drug manufacturer that 42 is registered with the United States Food and Drug Administration. 43 2. Each form of insulin produced pursuant to subdivision one of this 44 section shall be made available to providers, patients, and purchasers 45 at a price not to exceed thirty dollars per monthly dose for residents 46 of the state. 47 § 288. Proprietary information. Notwithstanding any provision of law 48 to the contrary, all nonpublic information and documents obtained by the 49 department pursuant to this title shall not be required to be disclosed 50 pursuant to article six of the public officers law. 51 § 2. This act shall take effect immediately.