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
________________________________________________________________________
3518
2023-2024 Regular Sessions
IN SENATE
January 31, 2023
___________
Introduced by Sen. FERNANDEZ -- read twice and ordered printed, and when
printed to be committed to the Committee on Consumer 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
21 medicaid managed care plans, health carriers and pharmacy benefits
22 managers doing business in the state in a format and manner prescribed
23 by the attorney general.
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD00235-01-3
S. 3518 2
1 2. The office of the attorney general shall post on its website all
2 the notices required pursuant to paragraph (a) of subdivision one of
3 this section in a format and manner developed by the attorney general
4 that is searchable by drug, cost, disease, and manufacturer both for the
5 brand and generic drug for public review.
6 3. For a violation by a manufacturer of a brand name drug who knowing-
7 ly or negligently fails to notify the attorney general as required in
8 paragraph (a) of subdivision one of this section, the attorney general
9 shall fine such manufacturer no less than five thousand dollars for the
10 first violation for each day such manufacturer fails to properly notify
11 the attorney general pursuant to the requirements of this section and no
12 less than ten thousand dollars for each violation thereafter for each
13 day such manufacturer fails to properly notify the attorney general
14 pursuant to the requirements of this section.
15 4. The attorney general is authorized to promulgate rules and regu-
16 lations necessary for the implementation of this section.
17 § 3. This act shall take effect on the one hundred eightieth day after
18 it shall have become a law.
