arrow_back Back to App

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.
article Official text account_balance Process page
Expired
Citizen Poll
No votes cast
Additional Information
Print number: 118_HR_456
Sponsor: Rep. Carter, Earl L. "Buddy" [R-GA-1]
Process start date: 2023-01-24
Lustra uses Artificial Intelligence. Verify details in source documents.
Summarized by: gemini-2.5-flash-preview-05-20
Source data: api.congress.gov
AI work logs for this document launch

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 118_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.

CATEGORIES

Health