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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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Expired
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Additional Information
Print number: 117_S_250
Sponsor: Sen. Cassidy, Bill [R-LA]
Process start date: 2021-02-04
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Summarized by: gemini-2.5-flash-preview-05-20
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

Fairness in Orphan Drug Exclusivity Act

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 117_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.

CATEGORIES

Health