PlainBillCongress, translated.Legislation. Context. Public interest.Congressional Research Service
Version 49 · Public Law · Jan 5, 2021
Orange Book Transparency Act of 2020
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.
People & committees
Rep. Kelly, Robin L. [D-IL-2] · D–IL
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Became Public Law No: 116-290.
Became Public Law No: 116-290.
Signed by President.
Signed by President.
Presented to President.
Presented to President.
Motion to reconsider laid on the table Agreed to without objection.
On motion that the House agree to the Senate amendment Agreed to without objection. (text: CR H7130-7131)
Resolving differences -- House actions: On motion that the House agree to the Senate amendment Agreed to without objection.(text: CR H7130-7131)
Mrs. Dingell asked unanimous consent to take the bill, H.R. 1503 from the Speaker's Table and agree to the Senate amendment. (consideration: CR H7130-7131)
Mrs. Dingell asked unanimous consent that the House agree to the Senate amendment.
Message on Senate action sent to the House.
Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S7242-7243)
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.(text of amendment in the nature of a substitute: CR S7242-7243)
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
Measure laid before Senate by unanimous consent. (consideration: CR S7244)
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Motion to reconsider laid on the table Agreed to without objection.
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). (text: CR H3486-3487)
House roll call 187 · Individual votesPassed/agreed to in House: 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).(text: CR H3486-3487)
House roll call 187 · Individual votesConsidered as unfinished business. (consideration: CR H3491)
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.
DEBATE - The House proceeded with forty minutes of debate on H.R. 1503.
Considered under suspension of the rules. (consideration: CR H3486-3488)
Ms. Eshoo moved to suspend the rules and pass the bill, as amended.
Placed on the Union Calendar, Calendar No. 25.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-47.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-47.
Ordered to be Reported (Amended) by Voice Vote.
Committee Consideration and Mark-up Session Held.
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Subcommittee Consideration and Mark-up Session Held.
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
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Source last updated: May 28, 2025. Consult Congress.gov for the current record.
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Analyze H.R.1503 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.
Examine H.R.1503 through a progressive lens, focusing on fairness, access, economic inequality, and effects on vulnerable communities. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and distinguish stated goals from demonstrated outcomes.
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