Fairness in Orphan Drug Exclusivity Act (H.R. 1629 (117th)) — United States

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.

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Timeline

8 March 2021
Introduced
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.
Source: IntroReferral
8 March 2021
Introduced
Introduced in House
Source: IntroReferral
8 March 2021
Introduced
Introduced in House
Source: IntroReferral
9 March 2021
Referred
Referred to the Subcommittee on Health.
Source: Committee
11 May 2021
Floor
Considered under suspension of the rules. (consideration: CR H2181-2183; text: CR H2181-2182)
Source: Floor
11 May 2021
Vote
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.
Source: Floor
11 May 2021
Floor
DEBATE - The House proceeded with forty minutes of debate on H.R. 1629.
Source: Floor
11 May 2021
Floor
Mr. Pallone moved to suspend the rules and pass the bill.
Source: Floor
11 May 2021
Vote
On motion to suspend the rules and pass the bill Failed by the Yeas and Nays: (2/3 required): 250 - 168 (Roll no. 134).
Source: Floor
11 May 2021
Vote
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).
Source: Floor
17 May 2021
Reported
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.
Source: Floor
19 May 2021
Passed
Motion to reconsider laid on the table Agreed to without objection.
Source: Floor
19 May 2021
Vote
On passage Passed by the Yeas and Nays: 402 - 23 (Roll no. 150). (text: CR H2561)
Source: Floor
19 May 2021
Vote
Passed/agreed to in House: On passage Passed by the Yeas and Nays: 402 - 23 (Roll no. 150).(text: CR H2561)
Source: Floor
19 May 2021
Floor
Considered under the provisions of rule H. Res. 403. (consideration: CR H2560-2563)
Source: Floor
19 May 2021
Floor
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.
Source: Floor
19 May 2021
Floor
The previous question was ordered pursuant to the rule.
Source: Floor
20 May 2021
Introduced
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Source: IntroReferral

Votes

19 May 2021 · passed · On Passage · Passed · Official source

Yes 402 · No 23 · Abstain — · Absent/not voting 4

Showing the first 4 recorded positions. Vote totals above are complete.

11 May 2021 · failed · On Motion to Suspend the Rules and Pass · Failed · Official source

Yes 250 · No 168 · Abstain — · Absent/not voting 12

Showing the first 4 recorded positions. Vote totals above are complete.

Versions

Referred in Senate · 20 May 2021 · Download file
Engrossed in House · 19 May 2021 · Download file
Introduced in House · 8 March 2021 · Download file

Documents

8 official files

Referred in Senate (text)

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Referred in Senate (text)
Referred in Senate · EN · 20 May 2021
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Referred in Senate (PDF)
Referred in Senate · EN · 20 May 2021
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Engrossed in House (text)
Engrossed in House · EN · 19 May 2021
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Engrossed in House (PDF)
Engrossed in House · EN · 19 May 2021
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Passed House
summary · EN · 19 May 2021
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Introduced in House (text)
Introduced in House · EN · 8 March 2021
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Introduced in House (PDF)
Introduced in House · EN · 8 March 2021
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Introduced in House
summary · EN · 8 March 2021
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Related records

Sources

PoliticalRepo is an index and interpretation layer, not the authoritative legal source.

Official source: https://www.congress.gov/bill/117th-congress/house-bill/1629
Open data entity: https://api.congress.gov/v3/bill/117/hr/1629
us · 117-hr-1629 · source updated 6 December 2025

Fairness in Orphan Drug Exclusivity Act