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A7196Assembly2019-2020 SessionSame asS5169

Disclose Drug Delay Deals

Official title

“Enacts the manufacturer disclosure and transparency act”

Status
In Assembly Committee
Consumer Affairs And Protection
Impact
5/10
Moderate
Passage
0%

Bill progress

Step 2 of 7

In committee · Consumer Affairs And Protection

What's happening

This bill requires drug manufacturers to disclose agreements that delay generic drugs to the attorney general, with penalties for noncompliance.

Why it matters

  1. Increases transparency around "pay-for-delay" agreements. by requiring drug companies to disclose deals that postpone the release of cheaper generic drugs, making it harder for manufacturers to keep such arrangements secret and potentially deterring them.

  2. Enables oversight and action by multiple stakeholders. because the disclosed information is not only sent to the Attorney General, but also shared with Medicaid, health plans, and pharmacy benefit managers, providing these groups with more tools to monitor and possibly challenge anti-competitive practices.

  3. Promotes public awareness and accountability. by mandating that all reported agreements, including drug names, costs, diseases treated, and involved manufacturers, be posted online in a searchable format, empowering consumers, watchdogs, and the media to scrutinize pharmaceutical practices.

  4. Imposes meaningful financial penalties for noncompliance. , with fines starting at $5,000 per day and increasing to $10,000 per day for repeated violations, creating a strong incentive for manufacturers to follow the law and discouraging attempts to evade reporting.

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Who cares

  • Brand-name drug manufacturers

    Those doing business in New York would have to report arrangements delaying or preventing generic competition within 30 days or face daily fines for knowing or negligent failures to notify.

  • New York attorney general’s office

    The office would collect disclosures, post searchable notices online, share information with specified health care entities and impose fines for reporting violations.

  • Medicaid managed care plans, health carriers and pharmacy benefit managers

    They would receive disclosures detailing affected drugs, wholesale prices, manufacturers and the length of generic-entry delays.

  • Patients taking brand-name prescription drugs

    They could search public notices for arrangements delaying generic substitutes by drug, cost, disease and manufacturer.

Headline styles

Disclose Drug Delay Deals

Plain English, a few words. Used as the page title.

Sponsors

History

  1. Print number 7196a
  2. Amend (t) and recommit to consumer affairs and protection
  3. Referred to consumer affairs and protection
  4. Referred to consumer affairs and protection

Companion bill

The same bill in the other chamber. A bill becomes law when one version passes both houses and the governor signs it, so either number can carry it.

S5169Senate

Require Drug Deal Disclosure

In Senate Committee · Consumer Protection · Sponsor Alessandra Biaggi

Impact 5 · Moderate0% to pass

Full text

2 pagesUnderlined is new[Struck] is removedOfficial text on nysenate.gov ↗

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 -- recommitted to the Committee on Consumer Affairs and Protection in accordance with Assembly Rule 3, sec. 2 -- 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 Assembly, do enact as follows:

Section 1. This act shall be known and may be cited as the "manufacturer disclosure and transparency act".

§ 2. The general business law is amended by adding a new section 396- rrr to read as follows:

§ 396-rrr. Delay of introduction of generic medications. 1. (a) Each pharmaceutical manufacturer doing business in this state that manufactures a brand name prescription drug and enters into an arrangement, 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

that has the purpose or effect of delaying or preventing such other manufacturer from introducing a generic substitute for such drug into the marketplace shall, not later than thirty days after entering into such arrangement, send notice to the attorney general, in a form and manner prescribed by the attorney general, disclosing the name of such drug, the wholesale price, the disease such drug is commonly prescribed to treat, the manufacturer of such drug, the name of the generic manufacturer, and the length of the delay.

(b) The attorney general shall, no later than thirty days after receiving a notice pursuant to paragraph (a) of this subdivision, share the information with the drug utilization review board established under section three hundred sixty-nine-bb of the social services law, all medicaid managed care plans, health carriers and pharmacy benefits managers doing business in the state in a format and manner prescribed by the attorney general.

2. The office of the attorney general shall post on its website all the notices required pursuant to paragraph (a) of subdivision one of this section in a format and manner developed by the attorney general that is searchable by drug, cost, disease, and manufacturer both for the brand and generic drug for public review.

3. For a violation by a manufacturer of a brand name drug who knowingly or negligently fails to notify the attorney general as required in paragraph (a) of subdivision one of this section, the attorney general shall fine such manufacturer no less than five thousand dollars for the first violation for each day such manufacturer fails to properly notify the attorney general pursuant to the requirements of this section and no less than ten thousand dollars for each violation thereafter for each day such manufacturer fails to properly notify the attorney general pursuant to the requirements of this section.

4. The attorney general is authorized to promulgate rules and regulations necessary for the implementation of this section.

§ 3. This act shall take effect on the one hundred eightieth day after it shall have become a law.

Reflowed for reading: line numbers and page breaks removed. Cite the official text.

Summaries, headlines and scores are AI-generated from the official bill text. How we score bills. Source: NYS Open Legislation.