To allow the Secretary of Health and Human Services to deny approval of a new drug application for an opioid analgesic drug on the basis of such drug not being clinically superior to other commercially available drugs.
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 requirement for approval of new opioid analgesics Section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. It relies on appropriations and compliance mandates. The main policy areas are Healthcare Consumers and Healthcare.
Who Benefits and How
Patients and health care consumers affected by the bill could gain revenue opportunities and Public beneficiaries or protected communities affected by the clause could face reduced risk.
Who Bears the Burden and How
Federal, state, or local agencies responsible for implementing the clause would take on compliance duties.
Key Provisions
- Provides requirement for approval of new opioid analgesics Section 505(c) 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 requirement for approval of new opioid analgesics Section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
Key Policy Areas
Healthcare Consumers, Healthcare
Primary Purpose
The bill provides requirement for approval of new opioid analgesics Section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
Policy Domains
Whole bill
Identified Gains
- Patients and health care consumers affected by the bill
- Public beneficiaries or protected communities affected by the clause
Identified Costs
- Federal, state, or local agencies responsible for implementing the clause
Sponsors
Legislative Progress
IntroducedMr. Manchin (for himself and Mr. Braun) 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