Prescription Information Modernization Act of 2025
Prescription Information Modernization Act of 2025 would shift the way prescribing information (PI) for drugs (including biologics) is delivered. The bill allows manufacturers to provide required PI primarily through electronic means, while guaranteeing prescribers and dispensers the option to receive paper copies on request at no cost. It requires the Health and Human Services (HHS) Secretary to issue final regulations within a year to implement the change and to offer guidance on obtaining paper copies directly from manufacturers or distributors. It also directs an economic-impact-conscious approach and mandates a public workshop within two years to discuss how to improve the format, accessibility, and usability of PI. The new digital requirement would apply to drugs introduced or delivered for introduction into interstate commerce on the sooner of two dates: two years after enactment or the effective date of the final regulations.
Key Points
- 1Digital-first PI with a guaranteed opt-out for paper: Required prescribing information may be made available electronically, but manufacturers must let prescribers and dispensers choose to receive paper labeling as well, or request paper labeling on an as-needed basis, with prompt provision of paper copies at no extra cost.
- 2Rulemaking timeline and guidance: Within one year of enactment, HHS must issue final regulations implementing the electronic-PI provision and provide instructions for obtaining paper copies. Regulations should minimize negative economic impacts on prescribers and dispensers.
- 3Stakeholder engagement: Within two years, HHS (via the FDA) must hold a public workshop with relevant stakeholders to discuss optimizing PI format, accessibility, and usability.
- 4Effective date and scope: The amendment applies to drugs introduced or delivered for introduction into interstate commerce on the sooner of (a) two years after enactment or (b) the effective date of the final regulations. The term “drug” follows the FDCA definition.
- 5Legal basis and applicability: The change targets drugs subject to section 503(b)(1) and ties to existing labeling requirements, ensuring all labeling remains compliant with applicable law.