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.
Summary
This bill, titled the "manufacturer disclosure and transparency act," requires pharmaceutical manufacturers doing business in New York to notify the state Attorney General when they enter into certain patent settlement agreements that affect the timing of a drug or biological product’s commercial launch. The bill defines covered agreements broadly to include settlements or related side agreements tied to patent litigation, including agreements involving brand-name drugs, generic drugs, biosimilars, and interchangeable biological products.
Under the bill, a manufacturer must submit notice and the full text of the agreement, including attachments and exhibits, within 30 days of entering into the settlement. The Attorney General must then post the notice on a public website within 60 days in a searchable format by drug, cost, disease, and manufacturer. The bill also makes these notices public records under the Public Officers Law and imposes a civil penalty of $10,000 per day for failure to timely file the required notice.
Impact
The bill would add a new section 396-rrr to the General Business Law and create a state disclosure regime for patent settlement agreements that may delay generic or biosimilar competition. Its practical effect is to increase transparency around so-called "pay-for-delay" or other patent settlement arrangements by requiring public reporting to the Attorney General and online disclosure. It would affect pharmaceutical manufacturers, brand and generic drug companies, biosimilar applicants, and the Attorney General’s office, while potentially supporting oversight of drug pricing and market entry timing.
Sentiment
Based on the bill text and the absence of recorded committee debate or votes, the overall sentiment appears supportive of transparency and consumer protection. The bill’s sponsors and caption indicate an intent to curb hidden arrangements that delay generic medications, suggesting a policy goal of promoting competition and lowering drug costs. No contrary viewpoints are documented in the provided materials.
Contention
The main point of contention likely concerns the breadth of the disclosure requirement and the burden it places on pharmaceutical manufacturers, especially because it covers not only formal patent settlement agreements but also related side agreements executed within 60 days before or after settlement. Industry stakeholders may object to mandatory public disclosure of commercially sensitive agreements and the substantial daily penalty for noncompliance. Supporters, by contrast, would likely emphasize the public interest in transparency, generic drug access, and oversight of agreements that may postpone lower-cost alternatives.
Same As
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.
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.
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.
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.
Enacts the New York state pharmaceutical drug manufacturer and wholesaler disclosure act; requires pharmaceutical drug manufacturers and wholesalers to annually report to the New York department of health, for disclosure to the general public, all of its gifts to health care practitioners that prescribe drugs when such gifts have a value of seventy-five dollars or more; authorizes the commissioner of health to impose penalties and promulgate necessary rules and regulations.
To Prohibit Pharmaceutical Manufacturers From Restricting Or Limiting Prescription Medications To A Limited Distribution Network Of Out-of-state Pharmacies.
Provides for a public Settlement Agreement Information Database to contain certain information regarding settlements entered into by state agencies (EG NO IMPACT See Note)