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H.R. 1629: Fairness in Orphan Drug Exclusivity Act

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To amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs, and for other purposes.

The bill’s titles are written by its sponsor.

Sponsor and status

Madeleine Dean

Sponsor. Representative for Pennsylvania's 4th congressional district. Democrat.

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Last Updated: May 20, 2021
Length: 5 pages
Mar 8, 2021
117th Congress (2021–2023)

Passed House (Senate next) on May 19, 2021

This bill passed in the House on May 19, 2021 and goes to the Senate next for consideration.

Other activity may have occurred on another bill with identical or similar provisions.


2 Cosponsors (1 Democrat, 1 Republican)

3% chance of being enacted according to Skopos Labs (details)

Position statements

Statement of Administration Policy

President Joseph Biden [D]: H.R. 1629 – Fairness in Orphan Drug Exclusivity Act (May 17, 2021)

What legislators are saying

Rep. Dean Reintroduces Fairness in Orphan Drug Exclusivity Act
    — Rep. Madeleine Dean [D-PA4] (Sponsor) on Mar 9, 2021

Rep. Veasey (TX-33) Applauds Passage of Fairness in Orphan Drug Exclusivity Act
    — Rep. Marc Veasey [D-TX33] (Co-sponsor) on May 19, 2021

the daily leader: wednesday, may 19, 2021
    — Rep. Steny Hoyer [D-MD5] on May 18, 2021

More statements at ProPublica Represent...


Mar 8, 2021

Bills and resolutions are referred to committees which debate the bill before possibly sending it on to the whole chamber.

May 7, 2021
Text Published

Updated bill text was published as of Preprint (Suspension).

May 11, 2021
Failed in the House Under Suspension

Passage was attempted under a fast-track procedure called "suspension of the rules." The vote failed, but the bill can be voted on again.

May 13, 2021
Text Published

Updated bill text was published as of Preprint (Rule).

May 19, 2021
Passed House (Senate next)

The bill was passed in a vote in the House. It goes to the Senate next.

If this bill has further action, the following steps may occur next:
Passed Senate

Signed by the President

H.R. 1629 is a bill in the United States Congress.

A bill must be passed by both the House and Senate in identical form and then be signed by the President to become law.

Bills numbers restart every two years. That means there are other bills with the number H.R. 1629. This is the one from the 117th Congress.

How to cite this information.

We recommend the following MLA-formatted citation when using the information you see here in academic work:

“H.R. 1629 — 117th Congress: Fairness in Orphan Drug Exclusivity Act.” 2021. August 9, 2022 <>

Where is this information from?

GovTrack automatically collects legislative information from a variety of governmental and non-governmental sources. This page is sourced primarily from, the official portal of the United States Congress. is generally updated one day after events occur, and so legislative activity shown here may be one day behind. Data via the congress project.