H.R. 1629 · 117th Congress

Fairness in Orphan Drug Exclusivity Act

Introduced on Mar 8, 2021 by Madeleine Dean (D-PA-4). 2 cosponsors, 1 of them from another party. Latest action (May 20, 2021): Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Stage
Passed one chamber
Introduced
Mar 8, 2021
Cosponsors
2
1 from the other party
Policy area
Health
Open in the Congress explorerCongress.govAlert me

Progress

The furthest stage the measure reached. Simple and concurrent resolutions do not go to the President.

  1. Introduced
  2. Reported by committee
  3. Passed one chamber
  4. 4Passed both chambers
  5. 5Sent to the President
  6. 6Became law

Official title

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.

Subjects

  • Competition and antitrust
  • Drug safety, medical device, and laboratory regulation
  • Licensing and registrations
  • Marketing and advertising
  • Prescription drugs

Summary

By the Congressional Research Service (Passed House, May 19, 2021). Public domain.

Fairness in Orphan Drug Exclusivity Act

This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats. The sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.)

Under this bill, if a drug is designated as an orphan drug on the basis that there is no reasonable expectation that the sponsor will recover the costs of developing and distributing the drug from U.S. sales, the drug shall be granted the seven-year exclusivity period only if the sponsor demonstrates that there is no reasonable expectation that it will recover such costs specifically within its first 12 years of U.S. sales of the drug. This requirement shall also apply retroactively to an orphan drug that was granted such an exclusivity period before this bill's enactment.

When deciding whether an orphan drug meets this requirement, the FDA shall consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.

Sponsor and cosponsors

Cosponsors by party as of the day they signed on. Original cosponsors signed on the day of introduction.

Madeleine DeanD-PA-4Sponsor

Democrats · 1

Republicans · 1

Roll calls

Recorded votes on the measure. Most measures move by voice vote or unanimous consent, which record no individual positions.

  1. On Motion to Suspend the Rules and Pass
    May 11, 2021· House· Passage· Failed 250–168
  2. On Passage
    May 19, 2021· House· Passage· Passed 402–23

History

Every action as published, oldest first. Roll calls link to how each member voted.

  1. Mar 8, 2021Introduced in House
  2. Mar 8, 2021Introduced in House
  3. Mar 8, 2021 · HouseReferred to the Committee on Energy and Commerce, and in addition to the Committee on the Budget, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
  4. Mar 8, 2021 · HouseReferred to the Committee on Energy and Commerce, and in addition to the Committee on the Budget, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
  5. Mar 9, 2021 · HouseReferred to the Subcommittee on Health.
  6. May 11, 2021 · HouseMr. Pallone moved to suspend the rules and pass the bill.
  7. May 11, 2021 · HouseConsidered under suspension of the rules. (consideration: CR H2181-2183; text: CR H2181-2182)
  8. May 11, 2021 · HouseDEBATE - The House proceeded with forty minutes of debate on H.R. 1629.
  9. May 11, 2021 · HouseAt the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.
  10. May 11, 2021 · HouseConsidered as unfinished business. (consideration: CR H2184-2185)
  11. May 11, 2021Failed of passage/not agreed to in House: On motion to suspend the rules and pass the bill Failed by the Yeas and Nays: (2/3 required): 250 - 168 (Roll no. 134).House · Roll call 134
  12. May 11, 2021 · HouseOn motion to suspend the rules and pass the bill Failed by the Yeas and Nays: (2/3 required): 250 - 168 (Roll no. 134).House · Roll call 134
  13. May 17, 2021 · HouseRules Committee Resolution H. Res. 403 Reported to House. Rule provides for consideration of H.R. 1629 and H. Res. 275. The resolution provides for consideration of H.R. 1629 under a closed rule and H. Res. 275 under a closed rule. The resolution provides for one hour of debate on both the bill and resolution. The rule provides that H. Res. 398 is hereby adopted. The rule provides at any time through the legislative day of Thursday, May 20, 2021, the Speaker may entertain motions offered by the Majority Leader or designee with respect to multiple measures that were object of motions to suspend the rules on the legislative days of May 17 or 18, 2021.
  14. May 19, 2021 · HouseConsidered under the provisions of rule H. Res. 403. (consideration: CR H2560-2563)
  15. May 19, 2021 · HouseRule provides for consideration of H.R. 1629 and H. Res. 275. The resolution provides for consideration of H.R. 1629 under a closed rule and H. Res. 275 under a closed rule. The resolution provides for one hour of debate on both the bill and resolution. The rule provides that H. Res. 398 is hereby adopted. The rule provides at any time through the legislative day of Thursday, May 20, 2021, the Speaker may entertain motions offered by the Majority Leader or designee with respect to multiple measures that were object of motions to suspend the rules on the legislative days of May 17 or 18, 2021.
  16. May 19, 2021 · HouseDEBATE - The House proceeded with one hour of debate on H.R. 1629.
  17. May 19, 2021 · HouseThe previous question was ordered pursuant to the rule.
  18. May 19, 2021 · HousePOSTPONED PROCEEDINGS - At the conclusion of debate on H.R. 1629, the Chair put the question on passage and by voice vote, announced that the ayes had prevailed. Mrs. Greene (GA) demanded the yeas and nays and the Chair postponed further proceedings on the question of passage until a time to be announced.
  19. May 19, 2021 · HouseConsidered as unfinished business. (consideration: CR H2572-2573)
  20. May 19, 2021Passed/agreed to in House: On passage Passed by the Yeas and Nays: 402 - 23 (Roll no. 150).(text: CR H2561)House · Roll call 150
  21. May 19, 2021 · HouseOn passage Passed by the Yeas and Nays: 402 - 23 (Roll no. 150). (text: CR H2561)House · Roll call 150
  22. May 19, 2021 · HouseMotion to reconsider laid on the table Agreed to without objection.
  23. May 20, 2021 · SenateReceived in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Committees

Committees and subcommittees the measure was referred to.

Agencies in its committees' jurisdiction

Analisa's mapping of committee jurisdiction to federal agencies; the bill may touch others, or none of these.

Sources and method

Every figure on this page traces to these records.

  • Bill status: bills and resolutions, sponsors, actions, subjects and CRS summaries (U.S. Government Publishing Office (GovInfo), from Congress.gov (Library of Congress))GovInfo Bill Status bulk data (Congress.gov; summaries by the Congressional Research Service) · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Members of Congress, their terms, committees and identifiers (The @unitedstates project (from the Biographical Directory of the U.S. Congress, the House and the Senate))unitedstates/congress-legislators: legislators, committees and current committee membership · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: CC0 1.0 (public domain dedication)
  • House roll-call votes (Office of the Clerk, U.S. House of Representatives)Office of the Clerk, U.S. House of Representatives, roll-call vote records · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Senate roll-call votes and DW-NOMINATE scores (Voteview (UCLA Department of Political Science))Lewis, Jeffrey B., Keith Poole, Howard Rosenthal, Adam Boche, Aaron Rudkin, and Luke Sonnet (2026). Voteview: Congressional Roll-Call Votes Database. https://voteview.com/ · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: Free to use with the required citation
  • Lobbying disclosures (LD-1 registrations, LD-2 quarterly reports, LD-203 contribution reports) (Clerk of the U.S. House of Representatives)Clerk of the House, Lobbying Disclosure Act filings (organizations only; lobbyists' names are not loaded) · data current to Oct 6, 2026 · loaded Oct 6, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Positions are shown only where a roll call recorded them; voice votes and unanimous consent record none.