H.R. 1532: Scientific External Process for Educated Review of Therapeutics Act of 2025

This bill, known as the Scientific External Process for Educated Review of Therapeutics Act of 2025, aims to amend the Federal Food, Drug, and Cosmetic Act to establish a new process for externally led, science-focused drug development meetings. The primary goals of these meetings are to address challenges in developing drugs for rare diseases and conditions, identify scientific approaches to facilitate development, and align on novel drug development strategies.

Key Components of the Bill

• The Secretary of Health and Human Services will implement a process for conducting externally led, science-focused drug development meetings known as EL–SFDD meetings.
• These meetings will be open to medical experts, drug sponsors, scientific organizations, and patient organizations, allowing them to collaborate on the challenges encountered in drug development.
• The Reagan-Udall Foundation for the FDA will convene a minimum of four of these EL–SFDD meetings each year, each focusing on a different rare disease or group of diseases.
• A permanent Steering Committee will be created to advise on the meetings, recommending topics based on unmet therapeutic needs, the size of patient populations, and other factors.

Meeting Structure and Planning

The meetings will involve:

• Identifying specific objectives related to drug development challenges for the relevant rare disease or diseases.
• Drafting a proposed agenda and inviting stakeholders, including FDA representatives and patient organizations.

These consultations aim to ensure a comprehensive review of the issues at hand and to enhance communication between all involved parties.

Post-Meeting Actions

After an EL–SFDD meeting, the Reagan-Udall Foundation is required to publish:

• A transcript and recording of the meeting within 180 days.
• A summary analysis that outlines consensus areas, information gaps, and next steps based on the discussions held.

Impact on Drug Approvals

The Secretary will be required to publicly state if an EL–SFDD meeting influenced the approval or licensing of a drug. They must detail how the input from these meetings was factored into the decision-making process for drug approvals.

Funding and Reporting Requirements

The bill authorizes $1,000,000 for each fiscal year from 2026 through 2030 to support the implementation of these meetings. Additionally, the Secretary will submit an annual report to Congress summarizing the meetings held, their topics, the FDA's participation, and how the feedback from these meetings was utilized.

Definitions

Key terms are defined, including the meaning of EL–SFDD meetings and what constitutes rare diseases and conditions.

Implementation and Consultation

The bill emphasizes the importance of stakeholder consultation throughout the planning and execution of EL–SFDD meetings, ensuring that the perspectives of patients, experts, and industry representatives are valued in the drug development process.

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