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Fairness in Orphan Drugs: Changes to Market Exclusivity

This bill aims to change the rules for granting market exclusivity to drugs for rare diseases. Pharmaceutical companies will need to demonstrate that they cannot recover development costs from sales to obtain such exclusivity. The goal is to ensure access to orphan drugs while preventing excessive profits for companies.
Key points
Pharmaceutical companies must prove they cannot recover development costs from sales of orphan drugs to gain market exclusivity.
Market exclusivity can be revoked if a company fails to meet new cost recovery criteria.
These changes aim to increase fairness and accessibility of orphan drugs, potentially impacting their prices and availability.
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Status:
Expired
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Additional Information
Fairness in Orphan Drug Exclusivity Act
Print number: HR 456
Sponsor: Rep. Carter, Earl L. "Buddy" [R-GA-1]
Process start date: 2023-01-24
System Note: Lustra is free, publicly auditable civic infrastructure, with full source code available on GitHub. You are reading sterilized legislative data, processed by our radical neutrality engine to strip political spin and retain factual mechanics. We process only official government data. Original documents remain the authoritative source, always verify them if you can.
Summarized by: gemini-2.5-flash-preview-05-20
Source data: api.congress.gov
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Summary & Status

Key Questions about Fairness in Orphan Drugs: Changes to Market Exclusivity

A structured overview of the legislative process, official sources, status and civic context.

What is the official ID of this bill?

The official print number for this legislation is HR 456.

Which chamber initiated this legislation?

This legislation was initiated in the House of Representatives.

When did the legislative process begin?

The process officially started on 2023-01-24.

What are the main provisions?

Key points include:

  • Pharmaceutical companies must prove they cannot recover development costs from sales of orphan drugs to gain market exclusivity.
  • Market exclusivity can be revoked if a company fails to meet new cost recovery criteria.
  • These changes aim to increase fairness and accessibility of orphan drugs, potentially impacting their prices and availability.

What is the specific legal status?

The current status is Expired.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Rep. Carter, Earl L. "Buddy" [R-GA-1].

What is the latest detailed status?

The latest detailed status is: Referred to the Subcommittee on Health.

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-25.

Analysis and Potential Impact of HR 456

We don't know, that is up to you to decide. Summarizing raw data with AI is fundamentally different from predicting socio-economic outcomes. As of 2026, we believe impact assessment strictly requires a human in the loop to verify and judge. Review our public AI processing logs for full transparency, and use Lustra to track active legislation for instant status push notifications.

CATEGORIES

Health