To amend the Federal Food, Drug, and Cosmetic Act to establish a process for science-focused drug development meetings led by the Reagan-Udall Foundation for the Food and Drug Administration with respect to drugs for rare diseases and conditions, and for other purposes.
Summary
What This Bill Does
The bill creates a new framework for externally-led, science-focused drug development meetings (EL-SFDD) by the Reagan-Udall Foundation, establishes a Steering Committee, mandates FDA participation, requires post-meeting, establishes Section 770A of the Federal Food, Drug, and Cosmetic Act, which mandates the Secretary of HHS to develop a process for Foundation-led, science-focused drug development meetings, and establishes Section 770B of the Federal Food, Drug, and Cosmetic Act, requiring FDA to publicly disclose whether EL-SFDD meetings informed drug approval decisions, describe how input was incorporated into risk-benefit. It relies on appropriations, reporting requirements, and compliance mandates. The main policy areas are Health, Trade, and Science & Space.
Who Benefits and How
Reagan-Udall Foundation for the FDA could gain revenue opportunities, Pharmaceutical and biotechnology companies developing rare disease drugs could face lower compliance burdens, and Congress (oversight committees) would be affected.
Who Bears the Burden and How
FDA (Secretary of HHS) would take on compliance duties, FDA review divisions (CDER, CBER, CDRH) would take on compliance duties, and FDA Center for Drug Evaluation and Research (CDER) would take on compliance duties.
Key Provisions
- Creates a new framework for externally-led, science-focused drug development meetings (EL-SFDD) by the Reagan-Udall Foundation, establishes a Steering Committee, mandates FDA participation, requires post-meeting...
- Establishes Section 770A of the Federal Food, Drug, and Cosmetic Act, which mandates the Secretary of HHS to develop a process for Foundation-led, science-focused drug development meetings.
- Establishes Section 770B of the Federal Food, Drug, and Cosmetic Act, requiring FDA to publicly disclose whether EL-SFDD meetings informed drug approval decisions, describe how input was incorporated into risk-benefit...
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
The bill creates a new framework for externally-led, science-focused drug development meetings (EL-SFDD) by the Reagan-Udall Foundation, establishes a Steering Committee, mandates FDA participation, requires post-meeting, establishes Section 770A of the Federal Food, Drug, and Cosmetic Act, which mandates the Secretary of HHS to develop a process for Foundation-led, science-focused drug development meetings, and establishes Section 770B of the Federal Food, Drug, and Cosmetic Act, requiring FDA to publicly disclose whether EL-SFDD meetings informed drug approval decisions, describe how input was incorporated into risk-benefit.
Key Policy Areas
Health, Trade, Science & Space
Primary Purpose
The bill creates a new framework for externally-led, science-focused drug development meetings (EL-SFDD) by the Reagan-Udall Foundation, establishes a Steering Committee, mandates FDA participation, requires post-meeting, establishes Section 770A of the Federal Food, Drug, and Cosmetic Act, which mandates the Secretary of HHS to develop a process for Foundation-led, science-focused drug development meetings, and establishes Section 770B of the Federal Food, Drug, and Cosmetic Act, requiring FDA to publicly disclose whether EL-SFDD meetings informed drug approval decisions, describe how input was incorporated into risk-benefit.
Policy Domains
Section 1 - Short Title
Identified Gains
- Reagan-Udall Foundation for the FDA
- Pharmaceutical and biotechnology companies developing rare disease drugs
- Congress (oversight committees)
- Pharmaceutical companies with drugs pending approval
- Patients with rare diseases
Identified Costs
- FDA (Secretary of HHS)
- FDA review divisions (CDER, CBER, CDRH)
- FDA Center for Drug Evaluation and Research (CDER)
- FDA Center for Biologics Evaluation and Research (CBER)
Sponsors
Legislative Progress
No timeline data available
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
Congress (oversight committees), FDA (Secretary of HHS), FDA Center for Biologics Evaluation and Research
Positive-direction: Congress (oversight committees)
Negative-direction: FDA (Secretary of HHS), FDA Center for Biologics Evaluation and Research, FDA Center for Drug Evaluation and Research, FDA review divisions (CDER, CBER, CDRH)
Rare disease patient advocacy organizations, Reagan-Udall Foundation for the FDA
Pharmaceutical and biotechnology companies developing rare disease drugs, Pharmaceutical companies with drugs pending approval
General public and transparency advocates, Patients with rare diseases
Academic medical researchers specializing in rare diseases
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "the_secretary"
- → Secretary of Health and Human Services
- "the_foundation"
- → Reagan-Udall Foundation for the FDA
- "the_secretary"
- → Secretary of Health and Human Services
- "the_foundation"
- → Reagan-Udall Foundation for the FDA
- "steering_committee"
- → Science-Focused Drug Development Multistakeholder Steering Committee
- "the_secretary"
- → Secretary of Health and Human Services
Key Definitions
Terms defined in this bill
An externally led, science-focused drug development meeting
Has the meaning given such term in section 526 of the Federal Food, Drug, and Cosmetic Act (generally a disease affecting fewer than 200,000 persons in the US)
The Science-Focused Drug Development Multistakeholder Steering Committee established under subsection (b)(3)
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology