S 488 New York Senate · 2025 Regular Session

Enacts the manufacturer disclosure and transparency act

Summary
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.
Bill status passed 3 of 5 stages cleared
Introduction
Jan 2025
Committee Review
May 2026
Senate Passage
May 2026
Assembly Passage
Governor
Introduced Jan 8, 2025 Last action May 12, 2026
Maddy AI version diff · 1 comparison

What changed between versions

S488 S488A · 7 edits
MODERATE
The bill was amended to add a sponsor, update its legislative status, and significantly expand its scope by adding detailed definitions and a new requirement for disclosing patent settlement agreements. This change ensures the law covers a broader range of legal arrangements that might delay generic drug entry, moving beyond just general agreements to specifically include settlements related to patent litigation and biosimilar products.
Scope change
The bill's scope expanded from requiring notification for any agreement delaying generic drugs to specifically requiring notification for 'patent settlement agreements' and agreements involving biosimilars, with new definitions clarifying what constitutes these agreements.
SCOPE

Added a new requirement for pharmaceutical manufacturers to notify the attorney general of 'patent settlement agreements' that affect the launch date of drugs or biological products.

DEFINITION

Introduced seven new definitions to clarify terms like 'patent settlement agreement,' 'biosimilar,' 'interchangeable product,' and 'drug' to ensure consistent application of the law.

REQUIREMENT

Changed the notification requirement to specifically demand the full text of patent settlement agreements, including attachments and exhibits, rather than just general notice details.

Removed the previous requirement to share notice information with the drug utilization review board, Medicaid managed care plans, health carriers, and pharmacy benefits managers.

TIMELINE

Adjusted the timeline for the attorney general to post notices on their website from thirty days to sixty days after receiving the manufacturer's notice.

ENFORCEMENT

Revised the penalty structure to a flat fine of ten thousand dollars per day for non-compliance, removing the tiered penalty system based on whether it was the first or subsequent violation.

TECHNICAL

Added a severability clause to ensure that if any part of the new law is found unconstitutional, the rest of the bill remains in effect.

Floor votes · Senate Feb 25, 2025

How they voted

5011
Passed · 2 other
Total votes 63
Feb 25, 2025
D Democratic41
39 Yea 2
95% Yea
R Republican22
11 Yea 11 Nay
50% Nay
Vote distribution
All Yea All Nay Mixed No data
Full legislative history

Actions timeline

Total actions
22
Key actions
4
Committee
6
Amendments
1
May 12, 2026
Committee
REFERRED TO CONSUMER AFFAIRS AND PROTECTION
lower
May 12, 2026
Upper · Passed
PASSED SENATE
upper
May 12, 2026
Committee
REPORTED AND COMMITTED TO RULES
upper
Jan 7, 2026
Committee
REFERRED TO CONSUMER PROTECTION
upper
Jun 9, 2025
Committee
REFERRED TO CONSUMER AFFAIRS AND PROTECTION
lower
Jun 9, 2025
Upper · Passed
REPASSED SENATE
upper
May 22, 2025
Upper · Passed
AMENDED ON THIRD READING 488A
upper
Feb 25, 2025
Committee
REFERRED TO CONSUMER AFFAIRS AND PROTECTION
lower
Feb 25, 2025
Upper · Passed
PASSED SENATE
upper
Jan 8, 2025
Committee
REFERRED TO CONSUMER PROTECTION
upper
1 primary · 3 co-sponsors

Sponsors