Establishes a generic drug research and development laboratory and production facility to manufacture generic prescription drugs in the state and the empire state biosimilar insulin initiative, which will develop generic forms of the three most widely used forms of insulin.
STATE OF NEW YORK
________________________________________________________________________
9535
IN ASSEMBLY
March 20, 2024
___________
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-
24 ment shall establish a generic drug research and development laboratory
25 and production facility within the university of the state of New York
26 system.
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD13501-01-3
A. 9535 2
1 (b) The generic drug research and development laboratory and
2 production facility established pursuant to paragraph (a) of this subdi-
3 vision shall produce and distribute generic prescription drugs, with the
4 intent that these drugs be made widely available to public and private
5 purchasers, facilities licensed pursuant to article twenty-eight of this
6 chapter, and pharmacies as defined in section six thousand eight hundred
7 two of the education law, as appropriate.
8 (c) Each drug produced pursuant to paragraph (b) of this subdivision
9 shall be made available to providers, patients, and purchasers at a
10 price not to exceed the cost of such production for residents of the
11 state.
12 (d) The department shall prioritize the development and production of
13 generic prescription drugs that have the greatest impact on lowering
14 drug costs to patients, increasing competition and addressing shortages
15 in the prescription drug market, improving public health, or reducing
16 the cost of prescription drugs to public and private purchasers.
17 2. The first initiative of the generic drug research and development
18 laboratory and production facility established pursuant to subdivision
19 one of this section shall be the empire state biosimilar insulin initi-
20 ative. Such initiative shall include the research, development, and
21 production of generic forms of the three most widely used forms of insu-
22 lin. Such insulin shall be produced or distributed by a non-profit
23 generic drug manufacturer that is registered with the United States Food
24 and Drug Administration.
25 3. Until such time as the generic drug research and development labo-
26 ratory and production facility is completed and the empire state biosi-
27 milar insulin initiative begins, the commissioner shall enter into part-
28 nerships resulting in the production or distribution of at least one
29 generic form of insulin pursuant to section two hundred eighty-seven of
30 this title.
31 § 287. Partnerships; production and distribution of prescription
32 drugs. 1. The commissioner shall enter into partnerships resulting in
33 the production or distribution of at least one generic form of insulin,
34 with the intent that such insulin be made widely available to public and
35 private purchasers, facilities licensed pursuant to article twenty-eight
36 of this chapter, and pharmacies as defined in section six thousand eight
37 hundred two of the education law, as appropriate. Such insulin shall be
38 produced or distributed by a non-profit generic drug manufacturer that
39 is registered with the United States Food and Drug Administration.
40 2. Each form of insulin produced pursuant to subdivision one of this
41 section shall be made available to providers, patients, and purchasers
42 at a price not to exceed thirty dollars per monthly dose for residents
43 of the state.
44 § 288. Proprietary information. Notwithstanding any provision of law
45 to the contrary, all nonpublic information and documents obtained by the
46 department pursuant to this title shall not be required to be disclosed
47 pursuant to article six of the public officers law.
48 § 2. This act shall take effect immediately.
