H.R. 1629Fairness in Orphan Drug Exclusivity Act

2 recorded actions230 of these members are on the 2026 ballotWhat the measure does Read on Congress.gov

Sponsor: Madeleine Dean [D-PA-04]
Cosponsors: 2 · 1 Democrat · 1 Republican
Policy area: Health
Committees: Energy and Commerce Committee, Budget Committee · and 1 more
Latest action: May 20, 2021 · Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

IntroducedMar 8, 2021
Passed the HouseMay 19, 2021
Passed the SenateNot yet reached
Sent to the PresidentNot yet reached
Became lawNot yet reached

What the measure doesCRS summary

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.

Written by the nonpartisan Congressional Research Service, describing H.R. 1629 as passed House on May 19, 2021. It is not the text of the measure; a later amendment may have changed what it does.

Roll calls on H.R. 16292 roll calls on this measure

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May 11, 2021Each bar: ✓ Yea from the bottom, ✕ Nay aboveMay 19, 2021

How every member votedHouse roll call 150

House May 19, 2021 · the primary vote

On Passage

Fairness in Orphan Drug Exclusivity Act

Passed

402 Yea 23 Nay 4 not voting

Crossed both parties 23 of 425 voting members broke with their own party: 23 Republicans.

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How the chamber split

One dot per member. Select a seat or a bar to filter the list.

DemocratsRepublicansFilled: YeaRing: NayGrey: not voting or present

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All members429 members

Democratic218 members

Republican211 members

marks half of the votes cast. A party’s majority is the side most of its voting members took.

Cosponsors2 · 1 Democrat · 1 Republican

Signing on is not a vote: a member can cosponsor H.R. 1629 and vote against it. 1 signed when it was filed.

DMarc A. Veasey [D-TX-33]Original

RBrian K. Fitzpatrick [R-PA-01]Joined May 11, 20212026 profile

Who lobbied on H.R. 16297 organizations

Organizations that named H.R. 1629 in a lobbying disclosure. Only those that cited the bill by number appear, so this is a floor, not a full list.

GSK (FKA GLAXOSMITHKLINE INC.)

Copyright/Patent/Trademark · Health Issues · Budget/Appropriations · Medicare/Medicaid +1 more8 filings · 4th Quarter (Oct 1 - Dec 31) 2022Filing

TRAVERE THERAPEUTICSfiled by ALSTON & BIRD LLP

Health Issues · Medicare/Medicaid · Pharmacy · Medical/Disease Research/Clinical Labs +1 more7 filings · 4th Quarter (Oct 1 - Dec 31) 2022Filing

PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICAIts PAC: Pharmaceutical Research & Manufacturers of America Better Government Committee

Budget/Appropriations · Copyright/Patent/Trademark · Health Issues · Medicare/Medicaid +1 more6 filings · 4th Quarter (Oct 1 - Dec 31) 2022Filing

BRAEBURN INC FORMERLY KNOWN AS BRAEBURN PHARMACEUTICALS INCfiled by BRAEBURN INC. FORMERLY KNOWN AS BRAEBURN PHARMACEUTICALS INC

Alcohol and Drug Abuse · Health Issues · Medicare/Medicaid · Insurance +1 more5 filings · 4th Quarter (Oct 1 - Dec 31) 2021Filing

BRAEBURN PHARMACEUTICALS, INC.filed by STANTON PARK GROUP

Health Issues5 filings · 1st Quarter (Jan 1 - Mar 31) 2022Filing

BIOTECHNOLOGY INNOVATION ORGANIZATIONIts PAC: Biotechnology Innovation Organization PAC

Agriculture · Animals · Budget/Appropriations · Chemicals/Chemical Industry +11 more3 filings · 2nd Quarter (Apr 1 - June 30) 2022Filing

NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD)filed by NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)

Pharmacy · Health Issues · Medicare/Medicaid · Budget/Appropriations1 filing · 3rd Quarter (July 1 - Sep 30) 2021Filing

35 disclosures name this measure. Retrieved from LDA.gov on 2026-10-04. Senate Office of Public Records cannot vouch for the data or analyses derived from these data after the data have been retrieved from LDA.gov.