To allow sponsors of certain new drug applications to rely upon investigations conducted in certain foreign countries, and for other purposes.
Analysis under review: This bill has generated analysis that may be too generic or incomplete. Clause-level evidence remains available below.
Summary
What This Bill Does
The bill provides drugs approved in certain foreign countries Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. It relies on definition changes, appropriations, reporting requirements, and compliance mandates. The main policy areas are Healthcare Consumers, Education, Foreign Policy, and Healthcare.
Who Benefits and How
The main beneficiaries are the people, organizations, or agencies identified in the bill's substantive provisions.
Who Bears the Burden and How
Federal, state, or local agencies responsible for implementing the clause would take on compliance duties, Patients and health care consumers affected by the bill could lose revenue opportunities, and Foreign businesses and cross-border trade participants affected by the bill could lose revenue opportunities.
Key Provisions
- Provides drugs approved in certain foreign countries Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
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 provides drugs approved in certain foreign countries Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
Key Policy Areas
Healthcare Consumers, Education, Foreign Policy, Healthcare
Primary Purpose
The bill provides drugs approved in certain foreign countries Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
Policy Domains
Whole bill
Identified Costs
- Federal, state, or local agencies responsible for implementing the clause
- Patients and health care consumers affected by the bill
- Foreign businesses and cross-border trade participants affected by the bill
- Educational institutions and students affected by the bill
Sponsors
Mike Braun
R-IN | Primary Sponsor
Legislative Progress
IntroducedMr. Braun (for himself and Mr. Paul) introduced the following …
Impact analysis is available but no clear stakeholder effects identified. View clause-level analysis →
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
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