S. 2027: Prescription Information Modernization Act of 2025
This bill, known as the Prescription Information Modernization Act of 2025, primarily aims to update how drug prescribing information is communicated to healthcare professionals and pharmacists. Here are the key points of what the bill would do:
Digital Communication of Prescribing Information
The bill allows the required prescribing information for certain drugs, specifically those that are subject to FDA approval under section 503(b)(1), to be provided entirely through electronic means. This means that manufacturers can deliver drug information online rather than in paper form. However, there are provisions to ensure accessibility for those who prefer or require physical copies:
- Manufacturers must offer prescribers and dispensers the option to continue receiving paper information if they choose.
- If a healthcare provider requests physical copies, the manufacturer is required to provide those at no additional cost.
Regulatory Implementation
The bill mandates that, within one year of its enactment, the Secretary of Health and Human Services must issue final regulations to:
- Implement the amendment regarding electronic communication of prescribing information.
- Clarify how healthcare professionals can obtain paper copies from manufacturers if requested.
Additionally, the regulations should be designed to minimize any negative economic impacts on prescribers and dispensers resulting from this change.
Public Workshop
Within two years of the bill's enactment, there will be a public workshop conducted by the Secretary of Health and Human Services (acting through the Commissioner of Food and Drugs). This workshop will involve relevant stakeholders and will focus on optimizing the format, accessibility, and usability of prescribing information.
Effective Date
The changes proposed by this bill will take effect with respect to drugs that are introduced into the market either two years after the bill’s enactment or once the final regulations are in effect, whichever comes first.
Definition of Drug
The term "drug" in the context of this bill refers to the definition given in section 201 of the Federal Food, Drug, and Cosmetic Act.
Relevant Companies
- PFE - Pfizer Inc.: As a major pharmaceutical company, Pfizer may need to adjust its prescribing information distribution practices to comply with new electronic communication standards.
- AMGN - Amgen Inc.: This biotechnology firm may also be impacted by changes to how it provides prescribing information for its biologic products.
- BMY - Bristol-Myers Squibb Company: As a pharmaceutical company, Bristol-Myers Squibb will likely have to adapt to new regulations regarding digital communication for its drugs.
This is an AI-generated summary of the bill text. There may be mistakes.
Sponsors
2 bill sponsors
Actions
2 actions
| Date | Action |
|---|---|
| Jun. 11, 2025 | Introduced in Senate |
| Jun. 11, 2025 | Read twice and referred to the Committee on Health, Education, Labor, and Pensions. |
Corporate Lobbying
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