Prescription Information Modernization Act of 2025
Sponsored By: Representative Harshbarger, Diana [R-TN-1]
Introduced
Summary
Allows required FDA drug prescribing information to be provided electronically while preserving a free paper option for clinicians. The bill would let manufacturers make official prescribing labels available only online, require timely free paper copies on request, and set short deadlines for implementing rules.
Show full summary
- Healthcare professionals: Prescribers and dispensers would receive required prescribing information electronically by default, with the option to receive or request paper copies at no cost.
- Drug manufacturers: Would be permitted to supply required labeling solely by electronic means but must promptly provide paper labeling to any prescriber or dispenser who requests it and stay compliant with applicable law.
- Regulators and stakeholders: The Secretary of Health and Human Services must issue final regulations within 1 year and the FDA must convene a public workshop within 2 years to improve format, accessibility, and usability while minimizing economic impacts on clinicians.
- Timing: The change would take effect for drugs introduced or delivered for introduction into interstate commerce on the sooner of 2 years after enactment or the effective date of the final regulations.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 0 benefits, 0 costs, 1 mixed.
Digital drug labels with free paper option
If enacted, drug makers could provide required prescribing info for prescription drugs online instead of on paper. Doctors and pharmacists could choose to keep getting paper copies or request them anytime. Manufacturers would have to send paper copies quickly and for free. Electronic labels would still need to meet all legal rules. The FDA would issue final rules within 1 year and hold a public workshop within 2 years. The change would start for drugs shipped on the earlier of two dates: 2 years after enactment, or when the final rules take effect.
Sponsors & CoSponsors
Sponsor
Harshbarger, Diana [R-TN-1]
TN • R
Cosponsors
Sherrill
NJ • D
Sponsored 6/25/2025
Rep. Valadao, David G. [R-CA-22]
CA • R
Sponsored 6/25/2025
Davis (NC)
NC • D
Sponsored 6/25/2025
Rep. Calvert, Ken [R-CA-41]
CA • R
Sponsored 6/25/2025
Rep. Ross, Deborah K. [D-NC-2]
NC • D
Sponsored 6/25/2025
Rep. Letlow, Julia [R-LA-5]
LA • R
Sponsored 6/25/2025
Peters
CA • D
Sponsored 6/25/2025
Rep. Schneider, Bradley Scott [D-IL-10]
IL • D
Sponsored 6/25/2025
Womack
AR • R
Sponsored 6/25/2025
Rep. Tonko, Paul [D-NY-20]
NY • D
Sponsored 6/25/2025
Hudson
NC • R
Sponsored 9/10/2025
Ciscomani
AZ • R
Sponsored 9/10/2025
Timmons
SC • R
Sponsored 9/23/2025
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov