A 2289: 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.

  
  STATE OF NEW YORK ________________________________________________________________________ 2289 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 -- read once and referred to the Committee on Consumer Affairs and Protection 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. (a) Each 6 pharmaceutical manufacturer doing business in this state that manufac- 7 tures a brand name prescription drug and enters into an arrangement, 8 through agreement or otherwise, with another pharmaceutical manufacturer 9 that has the purpose or effect of delaying or preventing such other 10 manufacturer from introducing a generic substitute for such drug into 11 the marketplace shall, not later than thirty days after entering into 12 such arrangement, send notice to the attorney general, in a form and 13 manner prescribed by the attorney general, disclosing the name of such 14 drug, the wholesale price, the disease such drug is commonly prescribed 15 to treat, the manufacturer of such drug, the name of the generic 16 manufacturer, and the length of the delay. 17 (b) The attorney general shall, no later than thirty days after 18 receiving a notice pursuant to paragraph (a) of this subdivision, share 19 the information with the drug utilization review board established under 20 section three hundred sixty-nine-bb of the social services law, all EXPLANATION--Matter in italics (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD00774-01-5 
 A. 2289 2 1 medicaid managed care plans, health carriers and pharmacy benefits 2 managers doing business in the state in a format and manner prescribed 3 by the attorney general. 4 2. The office of the attorney general shall post on its website all 5 the notices required pursuant to paragraph (a) of subdivision one of 6 this section in a format and manner developed by the attorney general 7 that is searchable by drug, cost, disease, and manufacturer both for the 8 brand and generic drug for public review. 9 3. For a violation by a manufacturer of a brand name drug who knowing- 10 ly or negligently fails to notify the attorney general as required in 11 paragraph (a) of subdivision one of this section, the attorney general 12 shall fine such manufacturer no less than five thousand dollars for the 13 first violation for each day such manufacturer fails to properly notify 14 the attorney general pursuant to the requirements of this section and no 15 less than ten thousand dollars for each violation thereafter for each 16 day such manufacturer fails to properly notify the attorney general 17 pursuant to the requirements of this section. 18 4. The attorney general is authorized to promulgate rules and regu- 19 lations necessary for the implementation of this section. 20 § 3. This act shall take effect on the one hundred eightieth day after 21 it shall have become a law.