H.R. 1629House117th Congress (2021-2023)Passed House

Fairness in Orphan Drug Exclusivity Act

Introduced March 8, 2021

AI-Generated Summary

Updated February 7, 2026 at 11:51 PM UTC

The Fairness in Orphan Drug Exclusivity Act changes how exclusive market rights are given to orphan drugs. It tells the FDA to deny or revoke exclusivity unless the drug’s sponsor shows that the drug’s development costs are unlikely to be recovered from U.S. sales within 12 years. The rule applies to all drugs designated for rare diseases, no matter when they were designated or approved, and it mainly impacts pharmaceutical companies seeking orphan‑drug status and the patients who use those drugs.

Key Provisions

  • Adds a new limitation that exclusive approval or licensure for an orphan drug will not be granted or will be revoked unless the sponsor demonstrates the drug will not recoup development costs from U.S. sales within 12 years.
  • Requires sponsors of new applications (after enactment) to provide this cost‑recovery proof at the time of approval, and requires sponsors of existing approvals to submit proof within 60 days of the law taking effect.
  • Specifies that the sales used in the cost‑recovery calculation include all drugs made by the same sponsor or related entities that share the same orphan designation.
  • States that the new limitation applies to any orphan‑designated drug regardless of when it was designated, approved, or granted exclusivity.

Legislative Activity

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20 earlier actions
SenateIntro Referral Latest Action

Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

May 20, 2021

View full timeline
HouseIntro Referral

Introduced in House

March 8, 2021

HouseIntro Referral

Referred 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.

March 8, 2021

HouseCommittee

Referred to the Subcommittee on Health.

March 9, 2021

HouseFloor

Mr. Pallone moved to suspend the rules and pass the bill.

May 11, 2021 • 4:06 PM

HouseFloor

Considered under suspension of the rules. (consideration: CR H2181-2183; text: CR H2181-2182)

May 11, 2021 • 4:06 PM

HouseFloor

DEBATE - The House proceeded with forty minutes of debate on H.R. 1629.

May 11, 2021 • 4:06 PM

HouseFloor

At 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.

May 11, 2021 • 4:20 PM

HouseFloor

Considered as unfinished business. (consideration: CR H2184-2185)

May 11, 2021 • 6:30 PM

HouseFloor

Failed 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).

May 11, 2021 • 7:08 PM

HouseFloor

On motion to suspend the rules and pass the bill Failed by the Yeas and Nays: (2/3 required): 250 - 168 (Roll no. 134).

May 11, 2021 • 7:08 PM

HouseFloor

Rules 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.

May 17, 2021 • 5:02 PM

HouseFloor

Considered under the provisions of rule H. Res. 403. (consideration: CR H2560-2563)

May 19, 2021 • 12:32 PM

HouseFloor

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.

May 19, 2021 • 12:32 PM

HouseFloor

DEBATE - The House proceeded with one hour of debate on H.R. 1629.

May 19, 2021 • 12:32 PM

HouseFloor

The previous question was ordered pursuant to the rule.

May 19, 2021 • 12:45 PM

HouseFloor

POSTPONED 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.

May 19, 2021 • 12:46 PM

HouseFloor

Considered as unfinished business. (consideration: CR H2572-2573)

May 19, 2021 • 2:23 PM

HouseFloor

Passed/agreed to in House: On passage Passed by the Yeas and Nays: 402 - 23 (Roll no. 150).(text: CR H2561)

May 19, 2021 • 2:55 PM

HouseFloor

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

May 19, 2021 • 2:55 PM

HouseFloor

Motion to reconsider laid on the table Agreed to without objection.

May 19, 2021 • 2:55 PM

SenateIntro Referral

Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

May 20, 2021

Floor Debate

21 members

What members said about H.R. 1629 on the floor

8 Republicans13 Democrats
Sheila Jackson Lee
Rep. Sheila Jackson LeeD-TX-18 · May 19, 2021

Madam Speaker, I rise to speak in strong support of H. Res. 398, the Recognizing the Forthcoming Centennial of the 1921 Tulsa Race Massacre, recognizes one of the darkest moments in American history,…

Mary Gay Scanlon
Rep. Mary Gay ScanlonD-PA-5 · May 18, 2021

Madam Speaker, by direction of the Committee on Rules, I call up House Resolution 403 and ask for its immediate consideration. Madam Speaker, for the purpose of debate only, I yield the customary 30…

Sheila Jackson Lee
Rep. Sheila Jackson LeeD-TX-18 · May 18, 2021

Madam Speaker, I thank the manager for her leadership. I also thank all of those on the floor who understand the indignity of massacres, racism, and devastating histories that our country has faced.…

A. Drew Ferguson IV
Rep. A. Drew Ferguson IVR-GA-3 · May 14, 2021

Madam Speaker, I rise for the purpose of inquiring to the majority the schedule for the week to come. I yield to the gentleman from California (Mr. Aguilar), my friend and colleague, the vice chair…

Madeleine Dean
Rep. Madeleine DeanD-PA-4 · May 19, 2021

Madam Speaker, I thank Ranking Member Rodgers and Chairman Pallone for their leadership on this bill. I, once again, rise in support of H.R. 1629, the Fairness in Orphan Drug Exclusivity Act. This…

Show 8 more
Pete Aguilar
Rep. Pete AguilarD-CA-31 · May 14, 2021

Madam Speaker, I thank the gentleman for yielding. On Monday, the House will meet at 12 p.m. for morning-hour debate and 2 p.m. for legislative business, with votes expected no earlier than 6:30 p.m.…

Brian J. Mast
Rep. Brian J. MastR-FL-18 · May 18, 2021

Madam Speaker, I thank the gentlewoman for yielding. Why at this time should we come together bipartisanly on this vote? That is the question that I am going to attempt to answer. Members of this…

Frank Pallone, Jr.
Rep. Frank Pallone, Jr.D-NJ-6 · May 19, 2021

Madam Speaker, pursuant to House Resolution 403, I call up the bill (H.R. 1629) to amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of…

Michelle Fischbach
Rep. Michelle FischbachR-MN-7 · May 18, 2021

Madam Speaker, I thank the Representative from Pennsylvania for yielding me the customary 30 minutes, and I yield myself such time as I may consume. Madam Speaker, we are here today to debate the…

Frank Pallone, Jr.
Rep. Frank Pallone, Jr.D-NJ-6 · May 11, 2021

Madam Speaker, I move to suspend the rules and pass the bill (H.R. 1629) to amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan…

Brett Guthrie
Rep. Brett GuthrieR-KY-2 · May 11, 2021

Madam Speaker, I yield myself such time as I may consume. Madam Speaker, I rise today in support of the Fairness in Orphan Drug Exclusivity Act. The Orphan Drug Act was enacted to incentivize the…

Madeleine Dean
Rep. Madeleine DeanD-PA-4 · May 11, 2021

Madam Speaker, I thank Representative Guthrie and Chairman Pallone for their support of this critical legislation. Madam Speaker, I rise in support of H.R. 1629, the Fairness in Orphan Drug…

Henry C. "Hank" Johnson, Jr.
Rep. Henry C. "Hank" Johnson, Jr.D-GA-4 · May 18, 2021

Madam Speaker, 100 years ago this month, hundreds of Black men, women, and children were brutally terrorized, brutalized, and murdered in a massacre in the Greenwood district of Tulsa, Oklahoma.…

Show 11 more
James E. Clyburn
Rep. James E. ClyburnD-SC-6 · May 18, 2021

Madam Speaker, I rise today to urge unanimous support for H. Res. 398, recognizing the 100th anniversary of the 1921 Tulsa Race Massacre. As a former history teacher, I often quote George Santayana,…

Doris O. Matsui
Rep. Doris O. MatsuiD-CA-6 · May 18, 2021

Madam Speaker, I thank the gentlewoman for yielding. Madam Speaker, I rise today in support of the rule providing for consideration of Representative Chu's resolution condemning the horrific…

Carlos A. Gimenez
Rep. Carlos A. GimenezR-FL-26 · May 18, 2021

Madam Speaker, I rise in opposition to the previous question and, if defeated, I urge my colleagues to adopt H.R. 261 by my friend and colleague, Representative Brian Mast. This legislation places…

Cathy McMorris Rodgers
Rep. Cathy McMorris RodgersR-WA-5 · May 19, 2021

Madam Speaker, I yield myself such time as I may consume. Madam Speaker, I rise today in support of H.R. 1629, the Fairness in Orphan Drug Exclusivity Act. The Orphan Drug Act was enacted to…

Danny K. Davis
Rep. Danny K. DavisD-IL-7 · May 18, 2021

Madam Speaker, I want to thank Representative Sheila Jackson Lee for reminding us what a difference 100 years make. But, you know, 100 years or so ago, there was a race riot in Searcy, Arkansas.…

Steven Horsford
Rep. Steven HorsfordD-NV-4 · May 18, 2021

Madam Speaker, I rise in support of H. Res. 398, the resolution recognizing the forthcoming centennial of the 1921 Tulsa Race Massacre. One hundred years ago, the city of Tulsa, Oklahoma, was home to…

Nanette Diaz Barragán
Rep. Nanette Diaz BarragánD-CA-44 · May 18, 2021

Madam Speaker, I was unable to vote on Roll Call 147, House Resolution 403, the rule providing for consideration of H. Res. 275 and H.R. 1629. I intended to vote ``yes'' on the resolution.…

Al Green
Rep. Al GreenD-TX-9 · May 18, 2021

Madam Speaker, the great writer and intellectual Carlyle was right, ``No lie can live forever.'' Kill 300 people? No lie can live forever. Destroy an entire business district? Try to hide it? No lie…

David B. McKinley
Rep. David B. McKinleyR-WV-1 · May 12, 2021

Madam Speaker, I voted No on H.R. 1629. Although I support the bill, I do not support the tactics by which it was brought to the floor. H.R. 1629 was once a bipartisan bill but now, like so many…

Peter A. DeFazio
Rep. Peter A. DeFazioD-OR-4 · May 14, 2021

Madam Speaker, on May 11, 2021, I was unavoidably detained and missed the day's vote. Had I been present, I would have voted Yea on Roll Call Vote 134, on the Motion to Suspend the Rules and Pass…

Michael R. Turner
Rep. Michael R. TurnerR-OH-10 · May 18, 2021

Mr. Speaker, I was unavoidably detained. Had I been present, I would have voted ``nay'' on rollcall No. 147.

Bill Text

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Referred in SenateIssued May 20, 2021

IIB

117th CONGRESS

1st Session

H. R. 1629

IN THE SENATE OF THE UNITED STATES

May 20, 2021

Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions

AN ACT

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.

1.

Short title

This Act may be cited as the Fairness in Orphan Drug Exclusivity Act.

2.

Limitations on exclusive approval or licensure of orphan drugs

(a)

In general

Section 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended—

(1)

in subsection (a), by striking Except as provided in subsection (b) and inserting Except as provided in subsection (b) or (f); and

(2)

by adding at the end the following:

(f)

Limitations on exclusive approval, certification, or license

(1)

In general

For a drug designated under section 526 for a rare disease or condition pursuant to the criteria set forth in subsection (a)(2)(B) of such section, the Secretary shall not grant, recognize, or apply exclusive approval or licensure under subsection (a), and, if such exclusive approval or licensure has been granted, recognized, or applied, shall revoke such exclusive approval or licensure, unless the sponsor of the application for such drug demonstrates—

(A)

with respect to an application approved or a license issued after the date of enactment of this subsection, upon such approval or issuance, that there is no reasonable expectation at the time of such approval or issuance that the cost of developing and making available in the United States such drug for such disease or condition will be recovered from sales in the United States of such drug, taking into account all sales made or reasonably expected to be made within 12 years of first marketing the drug; or

(B)

with respect to an application approved or a license issued on or prior to the date of enactment of this subsection, not later than 60 days after such date of enactment, that there was no reasonable expectation at the time of such approval or issuance that the cost of developing and making available in the United States such drug for such disease or condition would be recovered from sales in the United States of such drug, taking into account all sales made or reasonably expected to be made within 12 years of first marketing the drug.

(2)

Considerations

For purposes of subparagraphs (A) and (B) of paragraph (1), the Secretary and the sponsor of the application for the drug designated for a rare disease or condition described in such paragraph shall consider sales from all drugs that—

(A)

are developed or marketed by the same sponsor or manufacturer of the drug (or a licensor, predecessor in interest, or other related entity to the sponsor or manufacturer); and

(B)

are covered by the same designation under section 526.

(3)

Criteria

No drug designated under section 526 for a rare disease or condition pursuant to the criteria set forth in subsection (a)(2)(B) of such section shall be eligible for exclusive approval or licensure under this section unless it met such criteria under such subsection on the date on which the drug was approved or licensed.

.

(b)

Rule of construction

The amendments made in subsection (a) shall apply to any drug that has been or is hereafter designated under section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) for a rare disease or condition pursuant to the criteria under subsection (a)(2)(B) of such section regardless of—

(1)

the date on which such drug is designated or becomes the subject of a designation request under such section;

(2)

the date on which such drug is approved under section 505 of such Act (21 U.S.C. 355) or licensed under section 351 of the Public Health Service Act (42 U.S.C. 262) or becomes the subject of an application for such approval or licensure; and

(3)

the date on which such drug is granted exclusive approval or licensure under section 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) or becomes the subject of a request for such exclusive approval or licensure.

3.

Determination of budgetary effects

The budgetary effects of this Act, for the purpose of complying with the Statutory Pay-As-You-Go Act of 2010, shall be determined by reference to the latest statement titled Budgetary Effects of PAYGO Legislation for this Act, submitted for printing in the Congressional Record by the Chairman of the House Budget Committee, provided that such statement has been submitted prior to the vote on passage.

Passed the House of Representatives May 19, 2021.

Cheryl L. Johnson,

Clerk