Innovative FEED Act of 2025

Senate Bill

S. 1906

119th Congress

Innovative FEED Act of 2025

In Committee

Introduced:May 22, 2025

Primary Sponsor

Roger Marshall

Senator

Republican

KS

Cosponsors

19

Quick Stats

Policy Area

Health

Summary

The Innovative FEED Act would allow the Food and Drug Administration (FDA) to quickly approve certain drugs for serious or life-threatening diseases, even if full evidence of their safety and effectiveness is not yet available. This could provide faster access to potentially helpful treatments for patients with limited options.

Latest Action

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

SponsorRoger Marshall (R-KS)

Introduced5/22/2025

StatusRead twice and referred to the Committee on Agriculture, Nutrition, and Forestry.

ChamberSenate

Data from Congress.gov

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Vote Prediction

Innovative FEED Act of 2025

The Innovative FEED Act would allow the Food and Drug Administration (FDA) to quickly approve certain drugs for serious or life-threatening diseases, even if full evidence of their safety and effectiveness is not yet available. This could provide faster access

Community Breakdown

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The Innovative FEED Act would allow the Food and Drug Administration (FDA) to quickly approve certain drugs for serious or life-threatening diseases, even if full evidence of their safety and effectiveness is not yet available. This could provide faster access to potentially helpful treatments for patients with limited options.

Bill Number: 1906
Sponsor: Roger Marshall (R-KS)
Introduced: 5/22/2025
Status: Read twice and referred to the Committee on Agriculture, Nutrition, and Forestry.
Policy Area: Health

Data from Congress.gov

AI-generated summary

Fact Sheet

Title: Innovative FEED Act of 2025
Bill Number: 1906
Sponsor: Roger Marshall (R-KS)
Status: Read twice and referred to the Committee on Agriculture, Nutrition, and Forestry.
Introduced: 5/22/2025
Summary: The Innovative FEED Act would allow the Food and Drug Administration (FDA) to quickly approve certain drugs for serious or life-threatening diseases, even if full evidence of their safety and effectiveness is not yet available. This could provide faster access to potentially helpful treatments for p

Data from Congress.gov

AI Summary

Plain-English explanation of this bill

The Innovative FEED Act would allow the Food and Drug Administration (FDA) to quickly approve certain drugs for serious or life-threatening diseases, even if full evidence of their safety and effectiveness is not yet available. This could provide faster access to potentially helpful treatments for patients with limited options.

Last updated: 12/30/2025

Official Summary

Congressional Research Service summary

Promising Pathway Act This bill provides for expedited, provisional approval of drugs for serious or life-threatening diseases or conditions.Specifically, the bill allows for provisional approval of drugs that are used to treat, prevent, or diagnose a serious or life-threatening disease or condition for which premature death is likely without early medical intervention. The Food and Drug Administration (FDA) must evaluate applications within 90 days of receipt. The FDA may approve applications if there is early evidence, including real-world and real-time evidence, of the drug's efficacy, as well as substantial evidence of the drug's safety. Provisional approval is valid for two years and may be renewed for up to eight years. The FDA may withdraw provisional approval in the event of serious adverse health effects. Drug sponsors that receive provisional approval must require all patients receiving the drug to participate in an observational registry, through which the drug sponsor may collect and submit data relating to the drug until it is fully approved. Registries may be operated by the drug sponsor or another entity. The FDA must annually review these registries; sponsors of registries that fail to meet the bill's requirements are subject to civil penalties.

Key Points

Main provisions of the bill

Allows expedited, provisional approval of drugs for serious or life-threatening diseases or conditions, as long as there is early evidence of the drug's efficacy and substantial evidence of its safety.
Provisional approval is valid for 2 years and can be renewed for up to 8 years total.
Drug sponsors must require all patients receiving the provisionally approved drug to participate in an observational registry so more data can be collected.

How This Impacts Americans

Potential effects on citizens and communities

This bill would impact patients with serious or life-threatening diseases who may gain faster access to new treatment options, as well as drug companies developing these treatments. However, there are concerns about safety since full evidence is not required for provisional approval.

Policy Areas

Primary Policy Area

Health

Related Subjects

Administrative law and regulatory procedures

Civil actions and liability

Congressional oversight

Department of Health and Human Services

Drug safety, medical device, and laboratory regulation

Health information and medical records

Prescription drugs

Scope & Jurisdiction

Jurisdiction Level

federal

Congressional Session

119th Congress

Citation Reference

1906, 119th Congress (2025). "Innovative FEED Act of 2025". Source: Voter's Right Platform. https://votersright.org/bills/118-s-1906

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