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Fairness in Orphan Drugs: Ending Exclusivity for Profitable Medicines

This act changes the rules for granting market exclusivity for drugs intended for rare diseases. It aims to prevent abuses where companies receive special privileges even if the drug is already profitable. This could lead to greater availability and potentially lower prices for orphan drugs, as more companies may be able to produce them.
Key points
Limiting market exclusivity for rare disease drugs if their production and sales are already profitable.
Pharmaceutical companies must prove they won't recover development costs from sales to gain or keep exclusivity.
Changes apply to both new and already approved drugs, potentially increasing competition and access to orphan drugs.
article Official text account_balance Process page
VOTING RESULTS
2021-05-19
95%
For 402
Against 23
Abstain 0
Full voting results open_in_new
Expired
Citizen Poll
No votes cast
Additional Information
Print number: 117_HR_1629
Sponsor: Rep. Dean, Madeleine [D-PA-4]
Process start date: 2021-03-08
Voting date: 2021-05-19
Meeting no: 1
Voting no: 150
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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_HR_1629.

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 2021-03-08.

What are the main provisions?

Key points include:

  • Limiting market exclusivity for rare disease drugs if their production and sales are already profitable.
  • Pharmaceutical companies must prove they won't recover development costs from sales to gain or keep exclusivity.
  • Changes apply to both new and already approved drugs, potentially increasing competition and access to 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

Where is the official voting record?

The official roll call vote is recorded at: voting record

Who is the primary sponsor?

The primary sponsor is Rep. Dean, Madeleine [D-PA-4].

What is the latest detailed status?

The latest detailed status is: On passage Passed by the Yeas and Nays: 402 - 23 (Roll no. 150). (text: CR H2561)

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-27.

CATEGORIES

Health