S. 2027Senate119th Congress (2025-2027)In Committee

Prescription Information Modernization Act of 2025

AI-Generated Summary

Updated November 24, 2025 at 12:04 AM UTC

The Prescription Information Modernization Act of 2025 lets drug manufacturers provide prescribing information for FDA‑approved drugs and biologics primarily through electronic means. It still requires that doctors and pharmacists can request paper copies at no cost. The law directs HHS to issue rules and hold a stakeholder workshop to ensure the system is affordable and user‑friendly.

Key Provisions

Prescribing information for FDA‑approved drugs (including biologics) can be provided only electronically, as long as the labeling meets all legal requirements.
Prescribers and dispensers must be given the option to continue receiving paper copies, or to request paper copies when needed, and manufacturers must supply those copies promptly at no extra cost.
Within one year of the law’s enactment, HHS must issue final regulations to implement the electronic‑only rule and to explain how health‑care professionals can obtain paper copies.
The regulations must be designed to minimize any negative economic impact on prescribers and dispensers.
Within two years, HHS (through the FDA Commissioner) must hold a public workshop with stakeholders to discuss improving the format, accessibility, and usability of prescribing information.
The new electronic‑only requirement applies to drugs introduced into interstate commerce on or after the later of two years after enactment or the date the final regulations become effective.

Legislative Activity

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1 earlier action

SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

June 11, 2025

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SenateIntro Referral

Introduced in Senate

June 11, 2025

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

June 11, 2025

Bill Text

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Introduced in SenateIssued June 11, 2025

119th CONGRESS

1st Session

S. 2027

IN THE SENATE OF THE UNITED STATES

June 11, 2025

Mr. Mullin (for himself and Mr. Booker) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To provide for digital communication of prescribing information for drugs (including biological products), and for other purposes.

Short title

This Act may be cited as the Prescription Information Modernization Act of 2025.

Digital communication of FDA-approved prescribing information for drugs (including biological products)

(a)

In general

Section 502(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)) is amended by adding at the end the following: Required prescribing information for drugs subject to section 503(b)(1) may be made available solely by electronic means, provided that the labeling complies with all applicable requirements of law, that the manufacturer affords prescribers and dispensers the opportunity to elect to also continue to receive all such information in paper form or to request paper labeling on an as-needed basis, and, after such request, that the manufacturer promptly provides the requested information without additional cost..

(b)

Rulemaking

(1)

In general

Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue final regulations to—

(A)

implement the amendment made by subsection (a); and

(B)

provide instructions on how health care professionals can receive paper copies of prescribing information directly from the manufacturer or distributor if desired.

(2)

Economic impacts

The Secretary of Health and Human Services shall design the regulations required by paragraph (1) so as to minimize the adverse economic impacts of such regulations on prescribers and dispensers.

(c)

Public workshop

Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall hold a public workshop with relevant stakeholders to discuss how to continue to optimize the format, accessibility, and usability of prescribing information.

(d)

Effective date

The amendment made by subsection (a) shall apply with respect to drugs introduced or delivered for introduction into interstate commerce on or after the sooner of—

(1)

the date that is 2 years after the date of the enactment of this Act; or

(2)

the effective date of the final regulations promulgated to implement such amendment.

(e)

Definition

In this section, the term drug has the meaning given to such term in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).