To mitigate the effects of the COVID–19 pandemic on incentives under the Federal Food, Drug, and Cosmetic Act for the development of orphan drugs, 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 requires mitigation of effects of COVID–19 pandemic on orphan-drug development incentives In the case of a covered orphan drug, each of the following exclusivity periods is deemed to be extended by 180 days, so long. It relies on definition changes, compliance mandates, and delegation of rulemaking. The main policy areas are Healthcare Consumers, Criminal Justice, Housing, and Healthcare.
Who Benefits and How
Patients and health care consumers affected by the bill could face lower compliance burdens, Homeowners, tenants, or housing market participants affected by the bill could face lower compliance burdens, and Disaster response agencies and disaster-affected communities could face lower compliance burdens.
Who Bears the Burden and How
Federal, state, or local agencies responsible for implementing the clause would take on compliance duties.
Key Provisions
- Requires mitigation of effects of COVID–19 pandemic on orphan-drug development incentives In the case of a covered orphan drug, each of the following exclusivity periods is deemed to be extended by 180 days, so long...
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 requires mitigation of effects of COVID–19 pandemic on orphan-drug development incentives In the case of a covered orphan drug, each of the following exclusivity periods is deemed to be extended by 180 days, so long.
Key Policy Areas
Healthcare Consumers, Criminal Justice, Housing, Healthcare
Primary Purpose
The bill requires mitigation of effects of COVID–19 pandemic on orphan-drug development incentives In the case of a covered orphan drug, each of the following exclusivity periods is deemed to be extended by 180 days, so long.
Policy Domains
Whole bill
Identified Gains
- Patients and health care consumers affected by the bill
- Homeowners, tenants, or housing market participants affected by the bill
- Disaster response agencies and disaster-affected communities
Identified Costs
- Federal, state, or local agencies responsible for implementing the clause
Sponsors
Josh Gottheimer
D-NJ | Primary Sponsor
Legislative Progress
IntroducedMr. Gottheimer (for himself and Mr. Bacon) 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?
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