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
S00488, titled the “manufacturer disclosure and transparency act,” requires pharmaceutical manufacturers doing business in New York to notify the New York State Attorney General when they enter into certain patent settlement agreements that affect the timing of a drug or biologic’s commercial launch. The bill defines covered agreements broadly to include settlements tied to patent litigation, including agreements involving brand-name drugs, generic drugs, biosimilars, and interchangeable biological products, as well as related side agreements executed around the same time as the settlement.
Under the bill, a manufacturer must submit notice and the full text of the agreement, including attachments and exhibits, within 30 days of entering 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 and imposes a civil penalty of $10,000 per day for failure to timely file the required notice. The act takes effect 180 days after becoming law.
Impact
The bill would add a new section 396-rrr to the New York General Business Law, creating a state disclosure regime for patent settlement agreements that delay generic or biosimilar market entry. It would not directly ban such agreements, but it would require transparency and public reporting to the Attorney General, expanding state oversight of pharmaceutical patent settlements and potentially affecting brand-name drug manufacturers, generic manufacturers, biosimilar applicants, and consumers interested in drug pricing and competition.
Sentiment
The available voting history suggests generally favorable support for the bill, with strong committee approval and substantial floor majorities in the Senate. The Senate Consumer Protection Committee approved it 6-1, and later floor votes showed clear support, indicating that the measure was viewed positively as a transparency and consumer-protection bill. The absence of committee transcript excerpts limits insight into detailed debate, but the vote margins suggest broad agreement on the need for disclosure of agreements that may delay lower-cost drug competition.
Contention
The main point of contention is likely the scope of the disclosure requirement and the burden it places on pharmaceutical manufacturers, especially because it covers not only the settlement itself but also related agreements and requires submission of full texts and exhibits. Opponents may view the $10,000-per-day penalty as strict and the reporting obligation as potentially burdensome or intrusive, while supporters are likely to emphasize transparency, antitrust oversight, and the public interest in earlier access to lower-cost generic and biosimilar medications. The bill’s broad definitions of covered agreements and its inclusion of biologics may also be areas of concern for industry stakeholders.
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)