Orange Book Transparency Act of 2020
Public Law 116-290 · H.R. 1503 · 116th Congress · began in the House
Signed by Donald Trump (R) on Jan 5, 2021 · Health
Sponsor: Rep. Robin Kelly (D-IL-2)
Cosponsors (13): Rep. Raul Ruiz, Rep. Bobby Rush,
Passage votes
- HouseUnanimous consent
- SenateUnanimous consent
Data notes
The final version of the law, as each chamber passed it. A chamber that passed it by voice vote or unanimous consent has no count. “Method not stated” means the record does not say how the chamber voted. Where the record has a member-by-member vote, the “Who voted for it” section shows who voted yea.
Summary
The Congressional Research Service’s plain-language summary of what the law does.
This bill modifies requirements for the Food and Drug Administration (FDA)to list and publish drug patent and exclusivity information. Specifically, the FDA must include on its list certain patent information and must specify each drug exclusivity period that has not concluded.
The holder of an approved drug application must notify the FDA when a listed patent is invalidated by a court or by the Patent Trial and Appeal Board. The FDA must remove invalidated patents from its list, subject to the 180-day drug exclusivity period.
Committees
The committees the bill was sent to, and what each did with it.
Energy and Commerce Committee · House · markup by, referred to, reported bySubcommittee: Health Subcommittee
Data notes
A committee links to its page only where it exists in the current Congress; older and renamed committees are named without a link.
Related bills
2 bills the Library of Congress relates to this one.
H.R. 19Related bill
Lower Costs, More Cures Act of 2019
H.R. 1503Related bill
Orange Book Transparency Act of 2020
Data notes
Related bills are identified by the Congressional Research Service, the House and the Senate: companion and identical bills, bills with similar text, bills that were folded into this law, and rules that brought it to the floor. A bill that is itself a public law in this site’s data links here; the others link to Congress.gov.
Timeline
From introduction to signing, newest first: the committees, the floor and the president. 29 actions.
- Jan 5, 2021Became lawBecame law · Became Public Law No: 116-290.
- Became lawBecame law · Signed by President.
- Dec 24, 2020FloorFloor · Presented to President.
- Dec 10, 2020Resolving differencesResolving differences · Motion to reconsider laid on the table Agreed to without objection.
- Resolving differencesResolving differences · On motion that the House agree to the Senate amendment Agreed to without objection.
- Resolving differencesResolving differences · Mrs. Dingell asked unanimous consent that the House agree to the Senate amendment.
- FloorFloor · Mrs. Dingell asked unanimous consent to take the bill, H.R. 1503 from the Speaker's Table and agree to the Senate amendment.
- OtherOther · Resolving differences -- House actions: On motion that the House agree to the Senate amendment Agreed to without objection.
- Dec 8, 2020FloorFloor · Message on Senate action sent to the House.
- Dec 7, 2020FloorFloor · Passed Senate with an amendment by Unanimous Consent.
- FloorFloor · Measure laid before Senate by unanimous consent.
- CommitteeCommittee · Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
- May 9, 2019CommitteeCommittee · Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- May 8, 2019FloorFloor · Motion to reconsider laid on the table Agreed to without objection.
- FloorFloor · On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 422 - 0 (Roll no. 187).House roll call 187
- FloorFloor · Considered as unfinished business.
- FloorFloor · 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.
- FloorFloor · DEBATE - The House proceeded with forty minutes of debate on H.R. 1503.
- FloorFloor · Considered under suspension of the rules.
- FloorFloor · Ms. Eshoo moved to suspend the rules and pass the bill, as amended.
- May 2, 2019CalendarCalendar · Placed on the Union Calendar, Calendar No. 25.
- CommitteeCommittee · Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-47.
- Apr 3, 2019CommitteeCommittee · Ordered to be Reported (Amended) by Voice Vote.
- CommitteeCommittee · Committee Consideration and Mark-up Session Held.
- Mar 27, 2019CommitteeCommittee · Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
- CommitteeCommittee · Subcommittee Consideration and Mark-up Session Held.
- Mar 6, 2019CommitteeCommittee · Referred to the Subcommittee on Health.
- Mar 5, 2019CommitteeCommittee · Referred to the House Committee on Energy and Commerce.
- IntroducedIntroduced · Introduced in House
Data notes
Every action the Library of Congress lists for the bill, from introduction to signing, plus the dated committee hearings. The source lists many steps twice (the chamber’s own entry and the Library of Congress copy, or a presidential and a became-law entry with the same words); those are shown once. Amendments are listed in their own section.
Amendments
1 amendment offered to the bill, with the last recorded step of each.
- Agreed to
S.Amdt. 2693SenateSen. Lamar AlexanderR-TN· offered Dec 7, 2020Agreed to
In the nature of a substitute.
Dec 7, 2020: Amendment SA 2693 agreed to in Senate by Unanimous Consent.
Data notes
Amendments offered to this bill in either chamber, as the Library of Congress records them: each with a status read from its last recorded step: agreed to, rejected, withdrawn, ruled out of order, fell with another amendment, or offered with no vote recorded (most Senate amendments are only ever offered). The wording of each amendment is the source’s. Amendments to amendments and amendments to other bills are not listed.
Official record
The bill’s full text is on Congress.gov. Data through Oct 7, 2026.