Fairness in Orphan Drug Exclusivity Act
Latest action · Nov 18, 2020 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.
- IntroducedOct 17, 2019
- Passed HouseNov 17, 2020
- 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.
Cosponsors 7
Members who signed on, in the order they did. Signatures ran from Oct 17, 2019 to Nov 16, 2020; 3 are original cosponsors, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-WV | David B. McKinley | Original | Oct 17, 2019 |
| R-GA | Earl L. "Buddy" Carter | Original | Oct 17, 2019 |
| D-TX | Marc A. Veasey | Original | Oct 17, 2019 |
| D-NY | Paul Tonko | Dec 5, 2019 | |
| D-NJ | Andy Kim | Jul 16, 2020 | |
| D-FL | Darren Soto | Aug 4, 2020 | |
| R-TX | Van Taylor | Nov 16, 2020 |
Committees 2
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 Oct 17, 2019Markup Jul 15, 2020Reported Nov 16, 2020 |
| Health Subcommittee | Referred Oct 18, 2019Markup Mar 11, 2020Reported Mar 11, 2020 | |
| Senate | Health, Education, Labor, and Pensions Committee | Referred Nov 18, 2020 |
Actions 15
Everything that happened, newest first.
- Nov 18, 2020Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Nov 17, 2020Mr. Pallone moved to suspend the rules and pass the bill, as amended.
- Nov 17, 2020Considered under suspension of the rules. (consideration: CR H5807-5809)
- Nov 17, 2020DEBATE - The House proceeded with forty minutes of debate on H.R. 4712.
- Nov 17, 2020Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H5807)
In the Congressional Record 1
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 H5807–H5809Text printed H5807 | Anna G. Eshoo D-CA, David B. McKinley R-WV, Earl L. "Buddy" Carter R-GA, Frank Pallone, Jr. D-NJ, Greg Walden R-OR, Madeleine Dean D-PA | Nov 17, 2020 |
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.
Committee report
Constitutional authority
The sponsor’s statement, as printed in the Congressional Record, vol. 165, no. 164, October 17, 2019, page H8227.
Printed hearings 1
Hearings whose printed record names this bill, newest first: hearings on it, and wider hearings where it came up.
| Number | Hearing | Committee | Held |
|---|---|---|---|
| Serial No. 116-93 | IMPROVING SAFETY AND TRANSPARENCY IN AMERICA'S FOOD AND DRUGS350 pages | Energy and Commerce Committee | Jan 29, 2020 |
CRS reports 1
Congressional Research Service work that CRS links to this bill or the law it became, newest first.
Cite it 1
Products on other subjects that cite it, usually among other measures.
| Product | Title | Kind | Published |
|---|---|---|---|
| R46741 | Drug Pricing and Intellectual Property: The Legislative Landscape for the 117th Congress | Report | Mar 31, 2021 |
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 3271 | Fairness in Orphan Drug Exclusivity Act | Related bill | Feb 11, 2020 |
Titles 5
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 Reported to House
- 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 4
Each version as it was printed, newest first.
- Nov 18, 2020Referred in Senate
- Nov 17, 2020Engrossed in House
- Nov 16, 2020Reported in House
- Oct 17, 2019Introduced 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.
