Fairness in Orphan Drug Exclusivity Act
Latest action · May 20, 2021 Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedMar 8, 2021
- Passed HouseMay 19, 2021
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
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.
Recorded votes 2
Newest first. Open one to see how every member voted.
| Roll call | Question | Result | Date |
|---|---|---|---|
| House 150 | On Passage | Passed402–23 | May 19, 2021 |
| House 134 | On Motion to Suspend the Rules and Pass | Failed250–168 | May 11, 2021 |
Cosponsors 2
Members who signed on, in the order they did. Signatures ran from Mar 8, 2021 to May 11, 2021; 1 is an original cosponsor, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-TX | Marc A. Veasey | Original | Mar 8, 2021 |
| R-PA | Brian K. Fitzpatrick | May 11, 2021 |
Committees 3
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| House | Energy and Commerce Committee | Referred Mar 8, 2021 |
| Health Subcommittee | Referred Mar 9, 2021 | |
| House | Budget Committee | Referred Mar 8, 2021 |
| Senate | Health, Education, Labor, and Pensions Committee | Referred May 20, 2021 |
Actions 19
Everything that happened, newest first.
- May 20, 2021Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- May 19, 2021Considered under the provisions of rule H. Res. 403. (consideration: CR H2560-2563)
- May 19, 2021Rule 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, 2021DEBATE - The House proceeded with one hour of debate on H.R. 1629.
- May 19, 2021The previous question was ordered pursuant to the rule.
In the Congressional Record 6
Days the Record’s own index lists this bill, newest first, with the pages and the members it names. Pages starting H are the House, S the Senate, E Extensions of Remarks.
| Where | In the Record | Members | Date |
|---|---|---|---|
| House | Debate and remarks H2559, H2560–H2563Text printed H2561Recorded votes H2572enactLists H2573Votes recorded by proxy on H.R. 1629, Fairness in Orphan Drug Exclusivity Act | Cathy McMorris Rodgers R-WA, Frank Pallone, Jr. D-NJ, Madeleine Dean D-PA, Marc A. Veasey D-TX | May 19, 2021 |
| House | Debate and remarks H2473–H2481Text printed H2473Amendments H2479Recorded votes H2480consideration (H. Res. 403), previous questionLists H2480, H2481Votes recorded by proxy on H. Res. 403, consideration of H.R. 1629, Fairness in Orphan Drug Exclusivity ActVotes recorded by proxy on previous question to H. Res. 403, consideration of H.R. 1629, Fairness in Orphan Drug Exclusivity Act | Mary Gay Scanlon D-PA, Michelle Fischbach R-MN (amendment) | May 18, 2021 |
| House | Declaratory Statements H2422, H2423 | — | May 17, 2021 |
| House | Debate and remarks H2343 | Pete Aguilar D-CA | May 14, 2021 |
| Extensions | Debate and remarks E507 | David B. McKinley R-WV | May 12, 2021 |
| House | Debate and remarks H2181–H2183Text printed H2181Recorded votes H2184enactLists H2185Votes recorded by proxy on H.R. 1629, Fairness in Orphan Drug Exclusivity ActNotices H2192Estimated budget effects of H.R. 1629, Fairness in Orphan Drug Exclusivity Act | Brett Guthrie R-KY, Frank Pallone, Jr. D-NJ, John A. Yarmuth D-KY, Madeleine Dean D-PA | May 11, 2021 |
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Constitutional authority
The sponsor’s statement, as printed in the Congressional Record, vol. 167, no. 43, March 8, 2021, page H1121.
Related bills 2
Companion bills and other measures the record links to this one.
Titles 4
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- 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.
- Short Title(s) as Introduced
- Fairness in Orphan Drug Exclusivity Act
- Short Title(s) as Passed House
- Fairness in Orphan Drug Exclusivity Act
- Short Titles from RFS (Referred to Senate) bill text
- Fairness in Orphan Drug Exclusivity Act
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 3
Each version as it was printed, newest first.
- May 20, 2021Referred in Senate
- May 19, 2021Engrossed in House
- Mar 8, 2021Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
