Prescription Information Modernization Act of 2025
The Prescription Information Modernization Act of 2025 would shift FDA-approved prescribing information (labeling) for drugs, including biological products, to be provided primarily via electronic means. Manufacturers would still be required to offer the option for paper labeling, and to supply paper copies on request at no additional cost. The bill directs the FDA to issue final regulations within a year to implement this change and to guide how health professionals can obtain paper copies directly from manufacturers or distributors. It also requires a public workshop within two years to discuss ongoing improvements to the format, accessibility, and usability of prescribing information. The new digital labeling would apply to drugs introduced or delivered for interstate commerce after the later of two years from enactment or the final regulatory effective date.
Key Points
- 1Requires prescribing information for drugs (including biological products) to be provided primarily by electronic means, with an opt-out option to receive paper labeling on request.
- 2Paper labeling must be supplied promptly and at no extra cost after a patient or provider requests it.
- 3The Secretary of Health and Human Services must issue final regulations within one year to implement the amendment and provide instructions for obtaining paper copies.
- 4The regulations must be designed to minimize adverse economic impacts on prescribers and dispensers.
- 5A public workshop with stakeholders must be held within two years to discuss optimization of format, accessibility, and usability of prescribing information.
- 6Application is to drugs as defined in the FD&C Act (and includes biological products) and applies to drugs introduced or delivered into interstate commerce after the specified effective date.