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
________________________________________________________________________
S. 5169--A A. 7196--A
2019-2020 Regular Sessions
SENATE - ASSEMBLY
April 12, 2019
___________
IN SENATE -- Introduced by Sens. BIAGGI, BENJAMIN, CARLUCCI, GAUGHRAN,
HOYLMAN, JACKSON, MAY, MYRIE, PARKER, SALAZAR -- read twice and
ordered printed, and when printed to be committed to the Committee on
Consumer Protection -- recommitted to the Committee on Consumer
Protection in accordance with Senate Rule 6, sec. 8 -- committee
discharged, bill amended, ordered reprinted as amended and recommitted
to said committee
IN ASSEMBLY -- Introduced by M. of A. DenDEKKER, MOSLEY, JACOBSON,
COLTON, BUTTENSCHON, HEVESI, STIRPE, REYES, BARRON, PICHARDO,
SEAWRIGHT, CARROLL, LENTOL, LiPETRI, ASHBY, WEPRIN, SIMON, LIFTON,
BENEDETTO, D'URSO, HUNTER, MONTESANO, GOTTFRIED, CRUZ -- read once and
referred to the Committee on Consumer Affairs and Protection -- recom-
mitted to the Committee on Consumer Affairs and Protection in accord-
ance with Assembly Rule 3, sec. 2 -- committee discharged, bill
amended, ordered reprinted as amended and recommitted to said commit-
tee
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
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD11037-02-0
S. 5169--A 2 A. 7196--A
1 that has the purpose or effect of delaying or preventing such other
2 manufacturer from introducing a generic substitute for such drug into
3 the marketplace shall, not later than thirty days after entering into
4 such arrangement, send notice to the attorney general, in a form and
5 manner prescribed by the attorney general, disclosing the name of such
6 drug, the wholesale price, the disease such drug is commonly prescribed
7 to treat, the manufacturer of such drug, the name of the generic
8 manufacturer, and the length of the delay.
9 (b) The attorney general shall, no later than thirty days after
10 receiving a notice pursuant to paragraph (a) of this subdivision, share
11 the information with the drug utilization review board established under
12 section three hundred sixty-nine-bb of the social services law, all
13 medicaid managed care plans, health carriers and pharmacy benefits
14 managers doing business in the state in a format and manner prescribed
15 by the attorney general.
16 2. The office of the attorney general shall post on its website all
17 the notices required pursuant to paragraph (a) of subdivision one of
18 this section in a format and manner developed by the attorney general
19 that is searchable by drug, cost, disease, and manufacturer both for the
20 brand and generic drug for public review.
21 3. For a violation by a manufacturer of a brand name drug who knowing-
22 ly or negligently fails to notify the attorney general as required in
23 paragraph (a) of subdivision one of this section, the attorney general
24 shall fine such manufacturer no less than five thousand dollars for the
25 first violation for each day such manufacturer fails to properly notify
26 the attorney general pursuant to the requirements of this section and no
27 less than ten thousand dollars for each violation thereafter for each
28 day such manufacturer fails to properly notify the attorney general
29 pursuant to the requirements of this section.
30 4. The attorney general is authorized to promulgate rules and regu-
31 lations necessary for the implementation of this section.
32 § 3. This act shall take effect on the one hundred eightieth day after
33 it shall have become a law.