Prescription Information Modernization Act of 2025
- Bill Number
- H.R. 4132
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-06-25: Referred to the House Committee on Energy and Commerce.
- Last Updated
- 2025-12-10T09:05:38Z
AI-Generated Summary
Summary of H.R. 4132: Prescription Information Modernization Act of 2025
Purpose
This legislation aims to update rules for sharing prescribing information on drugs, including biological products, by allowing electronic delivery while preserving options for paper formats.
Key Provisions
- Digital Option for Labeling: Amends Section 502(f) of the Federal Food, Drug, and Cosmetic Act to permit manufacturers to provide required prescribing information solely through electronic means, as long as it meets all legal standards.
- Paper Backup Requirement: Manufacturers must offer prescribers and dispensers the choice to receive paper copies or request them on demand, with prompt delivery at no extra cost.
- Rulemaking Process: Directs the Secretary of Health and Human Services to issue final regulations within one year, including guidance on obtaining paper copies and efforts to limit negative economic effects on healthcare providers.
- Public Workshop: Requires the Food and Drug Administration to host a stakeholder workshop within two years to improve the format, access, and usability of prescribing information.
- Effective Date: Applies to drugs entering interstate commerce on or after the earlier of two years from enactment or the date final regulations take effect.
- Definition: Uses the existing definition of "drug" from the Federal Food, Drug, and Cosmetic Act.
Significant Changes to Existing Law
- Updates the misbranding provisions in 21 U.S.C. 352(f) by explicitly allowing electronic-only distribution of prescribing information, shifting from a presumed paper-based requirement.
- Introduces new regulatory mandates for implementation and stakeholder input, which were not previously specified in this section.
Potential Impacts
- On Government Agencies: Requires the Department of Health and Human Services and Food and Drug Administration to develop and enforce new regulations, conduct a workshop, and ensure compliance with minimal disruption to providers.
- On Citizens: Affects healthcare professionals by providing flexibility in receiving information but mandates options for paper access; indirect effects on patients through updated drug labeling practices.
- On International Relations: No provisions address international aspects.
Main Stakeholders Affected
- Drug and biological product manufacturers.
- Prescribers, such as physicians and other healthcare providers.
- Dispensers, including pharmacies and pharmacists.
- The Food and Drug Administration and Department of Health and Human Services.
- Patients who may benefit from improved information access.
Notable Legal, Constitutional, or Political Implications
- Represents a targeted amendment to the Federal Food, Drug, and Cosmetic Act focused on labeling flexibility without altering broader constitutional authorities or creating new enforcement mechanisms.
- Emphasizes regulatory design to reduce economic burdens on certain parties, though no explicit constitutional challenges or political directives are included.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Harshbarger, Diana [R-TN-1]
Cosponsors (16)
Rep. Sherrill, Mikie [D-NJ-11], Rep. Valadao, David G. [R-CA-22], Rep. Davis, Donald G. [D-NC-1], Rep. Calvert, Ken [R-CA-41], Rep. Ross, Deborah K. [D-NC-2], Rep. Letlow, Julia [R-LA-5], Rep. Peters, Scott H. [D-CA-50], Rep. Schneider, Bradley Scott [D-IL-10], Rep. Womack, Steve [R-AR-3], Rep. Tonko, Paul [D-NY-20], Rep. Hudson, Richard [R-NC-9], Rep. Ciscomani, Juan [R-AZ-6], Rep. Timmons, William R. [R-SC-4], Rep. Obernolte, Jay [R-CA-23], Rep. Neguse, Joe [D-CO-2], Rep. Vindman, Eugene Simon [D-VA-7]
Recent Actions
- 2025-06-25: Referred to the House Committee on Energy and Commerce.
- 2025-06-25: Introduced in House
- 2025-06-25: Introduced in House
Bill Versions
- Prescription Information Modernization Act of 2025 — issued 2025-06-25 — PDF (3 pages)