New York A 2289: Enacts the manufacturer disclosure and transparency act

Bill Text

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A02289 Summary:

BILL NOA02289A

&nbsp

SAME ASSAME AS S00488-A

&nbsp

SPONSORGallagher

&nbsp

COSPNSRStirpe, Forrest, Stern, Gonzalez-Rojas, Simon, Shimsky, Colton, Reyes, Simone, Raga, Shrestha,
 Seawright, Ramos, Rosenthal, Davila, Clark, Lupardo, Brown K, Epstein, Santabarbara, Romero,
 Kelles, Jacobson, Lasher, Griffin, Kassay, Moreno

&nbsp

MLTSPNSR

&nbsp

Add 396-rrr, Gen Bus L

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Enacts the manufacturer disclosure and transparency act requiring prescription drug manufacturers to notify the attorney general of arrangements between pharmaceutical manufacturers resulting in the delay of the introduction of generic medications.

Go to top A02289 Actions:

BILL NOA02289A

&nbsp

01/16/2025referred to consumer affairs and protection

05/22/2025amend and recommit to consumer affairs and protection

05/22/2025print number 2289a

01/07/2026referred to consumer affairs and protection

Go to topA02289 Committee&nbspVotes:

Go to topA02289 Floor&nbspVotes:

There are no Assembly votes for this bill in this legislative session.

Go to topA02289 Text:

 STATE OF NEW YORK
 ________________________________________________________________________

 2289--A

 2025-2026 Regular Sessions

 IN ASSEMBLY

 January 16, 2025
 ___________

 Introduced by M. of A. GALLAGHER, STIRPE, FORREST, MAMDANI, STERN,
 GONZALEZ-ROJAS, SIMON, SHIMSKY, COLTON, REYES, SIMONE, RAGA, SHRESTHA,
 SEAWRIGHT, RAMOS, ROSENTHAL, DAVILA, CLARK, LUPARDO, K. BROWN,
 EPSTEIN, SANTABARBARA, ROMERO, KELLES, JACOBSON -- read once and
 referred to the Committee on Consumer Affairs and Protection --
 committee discharged, bill amended, ordered reprinted as amended and
 recommitted to said committee

 AN ACT to amend the general business law, in relation to requiring
 prescription drug manufacturers to notify the attorney general of
 arrangements between pharmaceutical manufacturers resulting in the
 delay of the introduction of generic drugs

 The People of the State of New York, represented in Senate and Assem-
 bly, do enact as follows:

 1 Section 1. This act shall be known and may be cited as the "manufac-
 2 turer disclosure and transparency act".
 3 § 2. The general business law is amended by adding a new section 396-
 4 rrr to read as follows:
 5 § 396-rrr. Delay of introduction of generic medications. 1. For
 6 purposes of this section, the following terms shall have the following
 7 meanings:
 8 (a) "Agreement" means anything that would constitute an agreement
 9 under state law.
 10 (b) "Attorney general" means the office of the New York state attorney
 11 general.
 12 (c) "Patent settlement agreement" means any agreement that is entered
 13 into within sixty days of the resolution or the settlement of patent
 14 litigation, or any other agreement that is contingent upon, provides a
 15 contingent condition for, or is otherwise related to the resolution or
 16 settlement of patent litigation, including, without limitation:
 17 (i) any agreement required to be provided to the federal trade commis-
 18 sion or the antitrust division of the United States department of

 EXPLANATION--Matter in italics (underscored) is new; matter in brackets
 [ ] is old law to be omitted.
 LBD00774-05-5

 A. 2289--A 2

 1 justice under the Medicare Prescription Drug, Improvement, and Modern-
 2 ization Act of 2003, Pub. L. No. 108-173;
 3 (ii) any agreement between a biosimilar or interchangeable product
 4 applicant and a biological product deemed a reference product sponsor
 5 under the Biologics Price Competition and Innovation Act of 2009, Pub.
 6 L. No. 111-148, that resolves patent claims between the applicant and
 7 sponsor; or
 8 (iii) any agreement between parties to a patent settlement agreement
 9 executed sixty days before or after final execution of the patent
 10 settlement agreement and which either: (A) is intended to relate to the
 11 patent settlement agreement, such as including activities or actions
 12 contemplated under the patent settlement agreement; (B) references the
 13 patent settlement agreement or any obligation arising out of the patent
 14 settlement agreement, or is otherwise related to the patent settlement
 15 agreement; or (C) identifies, references or refers to any drug or active
 16 pharmaceutical ingredient that was the subject matter or referenced by
 17 the litigation that resulte