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Orphan Drugs: Ending Exclusivity When Profits Are High

This act changes the rules for granting exclusivity for drugs for rare diseases, known as orphan drugs. It aims to prevent companies from obtaining exclusivity even when development and availability costs can be recovered from sales. The goal is to increase drug accessibility and potentially lower prices for patients.
Key points
Pharmaceutical companies must prove they do not expect to recover orphan drug costs from sales to obtain or maintain exclusivity.
Orphan drug exclusivity can be revoked if it's found that the company could have recovered costs from sales within 12 years of market entry.
Changes apply to drugs approved both before and after this act's enactment, potentially affecting existing orphan drugs.
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Status:
Expired
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Additional Information
Fairness in Orphan Drug Exclusivity Act
Print number: S 250
Sponsor: Sen. Cassidy, Bill [R-LA]
Process start date: 2021-02-04
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 Orphan Drugs: Ending Exclusivity When Profits Are High

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 S 250.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2021-02-04.

What are the main provisions?

Key points include:

  • Pharmaceutical companies must prove they do not expect to recover orphan drug costs from sales to obtain or maintain exclusivity.
  • Orphan drug exclusivity can be revoked if it's found that the company could have recovered costs from sales within 12 years of market entry.
  • Changes apply to drugs approved both before and after this act's enactment, potentially affecting existing orphan drugs.

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 Sen. Cassidy, Bill [R-LA].

What is the latest detailed status?

The latest detailed status is: Introduced in Senate

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-29.

Analysis and Potential Impact of S 250

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