H.R. 4132: Prescription Information Modernization Act of 2025

The Prescription Information Modernization Act of 2025 aims to update how prescribing information for drugs and biological products is communicated to healthcare providers. The bill proposes several key changes:

Digital Communication Implementation

Under the proposed law, the Food and Drug Administration (FDA) could allow the required prescribing information for certain drugs to be provided only in electronic formats. This would apply to medications that are classified under specific regulatory sections. However, manufacturers would need to ensure that:

• The electronic information complies with existing legal requirements.
• Healthcare professionals still have the option to request paper copies of the information if they prefer.
• Manufacturers must promptly provide these paper copies at no extra charge if requested.

Regulatory Guidance

The Secretary of Health and Human Services is responsible for creating final regulations to implement these changes within one year of the bill's passage. This includes:

• Setting guidelines for manufacturers on how to provide paper copies upon request.
• Ensuring that the regulations aim to minimize negative economic impacts on healthcare providers.

Public Workshop

Within two years of the enactment of the bill, a public workshop must be held by the Secretary of Health and Human Services, with participation from stakeholders, to discuss improvements in the format, accessibility, and usability of prescribing information.

Effective Date

The changes made by this bill would take effect two years after its enactment or at the time when the final regulations are published, whichever comes first, for drugs introduced into commerce afterward.

Definition of Drug

The term "drug" used in the bill references the definition provided in the Federal Food, Drug, and Cosmetic Act, which includes a broad category of substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

Relevant Companies

• PFE (Pfizer Inc.): As a major pharmaceutical company that produces numerous drugs, Pfizer would be impacted by changes in how they deliver prescribing information to healthcare providers.
• MRK (Merck & Co., Inc.): Merck could see changes in their prescribing information dissemination, requiring updates to their communication strategies with providers.
• JNJ (Johnson & Johnson): With many products across various therapeutic areas, J&J may need to align with new electronic communication methods for prescribing information.