United States · Law · HR
H.R. 1503 (116th)
Orange Book Transparency Act of 2020
Introduced
5 March 2019
Last action
5 January 2021 · President
Status
Became Public Law No: 116-290.
Sponsors
Rep. Kelly, Robin L. [D-IL-2], Rep. Ruiz, Raul [D-CA-25], Rep. Rush, Bobby L. [D-IL-1], Rep. Pallone, Frank [D-NJ-6], Rep. Dingell, Debbie [D-MI-6], Rep. Eshoo, Anna G. [D-CA-18], Rep. Kennedy, Joseph P., III [D-MA-4], Rep. Matsui, Doris O. [D-CA-7], Rep. Craig, Angie [D-MN-2], Rep. Clarke, Yvette D. [D-NY-9], Rep. Van Drew, Jefferson [R-NJ-2], Rep. Walden, Greg [R-OR-2], Rep. Schakowsky, Janice D. [D-IL-9], Rep. Mucarsel-Powell, Debbie [D-FL-26]
Subjects
Healthcare
Source updated
28 May 2025
Summary
Orange Book Transparency Act of 2019 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.
This text is taken from the official record. PoliticalRepo does not editorialize.
Timeline
5 March 2019
Introduced
Referred to the House Committee on Energy and Commerce.
Source: IntroReferral
5 March 2019
Introduced
Introduced in House
Source: IntroReferral
5 March 2019
Introduced
Introduced in House
Source: IntroReferral
6 March 2019
Referred
Referred to the Subcommittee on Health.
Source: Committee
27 March 2019
Committee
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Source: Committee
27 March 2019
Committee
Subcommittee Consideration and Mark-up Session Held.
Source: Committee
3 April 2019
Reported
Ordered to be Reported (Amended) by Voice Vote.
Source: Committee
3 April 2019
Committee
Committee Consideration and Mark-up Session Held.
Source: Committee
2 May 2019
Calendars
Placed on the Union Calendar, Calendar No. 25.
Source: Calendars
2 May 2019
Reported
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-47.
Source: Committee
2 May 2019
Reported
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-47.
Source: Committee
8 May 2019
Passed
Motion to reconsider laid on the table Agreed to without objection.
Source: Floor
8 May 2019
Vote
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)
Source: Floor
8 May 2019
Vote
Passed/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)
Source: Floor
8 May 2019
Floor
Considered under suspension of the rules. (consideration: CR H3486-3488)
Source: Floor
8 May 2019
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
8 May 2019
Floor
DEBATE - The House proceeded with forty minutes of debate on H.R. 1503.
Source: Floor
8 May 2019
Floor
Ms. Eshoo moved to suspend the rules and pass the bill, as amended.
Source: Floor
9 May 2019
Introduced
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Source: IntroReferral
7 December 2020
Passed
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)
Source: Floor
7 December 2020
Discharge
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
Source: Discharge
7 December 2020
Committee
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
Source: Committee
7 December 2020
Floor
Measure laid before Senate by unanimous consent. (consideration: CR S7244)
Source: Floor
8 December 2020
Floor
Message on Senate action sent to the House.
Source: Floor
10 December 2020
Passed
Motion to reconsider laid on the table Agreed to without objection.
Source: ResolvingDifferences
10 December 2020
Passed
On motion that the House agree to the Senate amendment Agreed to without objection. (text: CR H7130-7131)
Source: ResolvingDifferences
10 December 2020
Passed
Resolving differences -- House actions: On motion that the House agree to the Senate amendment Agreed to without objection.(text: CR H7130-7131)
Source: NotUsed
10 December 2020
Floor
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)
Source: Floor
10 December 2020
ResolvingDifferences
Mrs. Dingell asked unanimous consent that the House agree to the Senate amendment.
Source: ResolvingDifferences
24 December 2020
Floor
Presented to President.
Source: Floor
24 December 2020
President
Presented to President.
Source: President
5 January 2021
Became law
Became Public Law No: 116-290.
Source: President
5 January 2021
Became law
Signed by President.
Source: BecameLaw
5 January 2021
President
Signed by President.
Source: President
Votes
8 May 2019 · passed · On Motion to Suspend the Rules and Pass, as Amended · Passed · Official source
Yes 422 · No 0 · Abstain — · Absent/not voting 9
- Rep. Ferguson, A. Drew, IV [R-GA-3]Yea
- Rep. McEachin, A. Donald [D-VA-4]Yea
- Rep. Hastings, Alcee L. [D-FL-20]Yea
- Rep. Finkenauer, Abby [D-IA-1]Yea
Showing the first 4 recorded positions. Vote totals above are complete.
Versions
- Enrolled Bill · — · Download file
- Public Law · 6 January 2021 · Download file
- Engrossed Amendment Senate · 7 December 2020 · Download file
- Referred in Senate · 9 May 2019 · Download file
- Engrossed in House · 8 May 2019 · Download file
- Reported in House · 2 May 2019 · Download file
- Introduced in House · 5 March 2019 · Download file
Documents
16 official files
Enrolled Bill (text)
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Enrolled Bill (text)
Enrolled Bill · EN
Enrolled Bill (PDF)
Enrolled Bill · EN
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Public Law (text)
Public Law · EN · 6 January 2021
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Public Law (PDF)
Public Law · EN · 6 January 2021
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Public Law
summary · EN · 5 January 2021
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Engrossed Amendment Senate (text)
Engrossed Amendment Senate · EN · 7 December 2020
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Engrossed Amendment Senate (PDF)
Engrossed Amendment Senate · EN · 7 December 2020
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Referred in Senate (text)
Referred in Senate · EN · 9 May 2019
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Referred in Senate (PDF)
Referred in Senate · EN · 9 May 2019
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Engrossed in House (text)
Engrossed in House · EN · 8 May 2019
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Engrossed in House (PDF)
Engrossed in House · EN · 8 May 2019
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Reported in House (text)
Reported in House · EN · 2 May 2019
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Reported in House (PDF)
Reported in House · EN · 2 May 2019
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Introduced in House (text)
Introduced in House · EN · 5 March 2019
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Introduced in House (PDF)
Introduced in House · EN · 5 March 2019
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Introduced in House
summary · EN · 5 March 2019
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Sponsors
- Rep. Kelly, Robin L. [D-IL-2] · D · Sponsor
- Rep. Ruiz, Raul [D-CA-25] · D · Cosponsor
- Rep. Rush, Bobby L. [D-IL-1] · D · Cosponsor
- Rep. Pallone, Frank [D-NJ-6] · D · Cosponsor
- Rep. Dingell, Debbie [D-MI-6] · D · Cosponsor
- Rep. Eshoo, Anna G. [D-CA-18] · D · Cosponsor
- Rep. Kennedy, Joseph P., III [D-MA-4] · D · Cosponsor
- Rep. Matsui, Doris O. [D-CA-7] · D · Cosponsor
- Rep. Craig, Angie [D-MN-2] · D · Cosponsor
- Rep. Clarke, Yvette D. [D-NY-9] · D · Cosponsor
- Rep. Van Drew, Jefferson [R-NJ-2] · D · Cosponsor
- Rep. Walden, Greg [R-OR-2] · R · Cosponsor
- Rep. Schakowsky, Janice D. [D-IL-9] · D · Cosponsor
- Rep. Mucarsel-Powell, Debbie [D-FL-26] · D · Cosponsor
- · sshr00 · Standing
- · hsif00 · Standing
Related records
- related to → Lower Costs, More Cures Act of 2019
- amends ← In the nature of a substitute.
Related across the Repo ecosystem
Direct relationships are identifier-backed. Topic context means shared TopicMembership — not a citation and not causation.
Direct relationships
- Legal framework · Orange Book Transparency Act of 2020 · H.R. 1503 (116th) · US
- Identifier matchPROJECTS_FROM
Same us record 116-hr-1503 projected from PoliticalRepo US row.
Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.congress.gov/bill/116th-congress/house-bill/1503
- Open data entity: https://api.congress.gov/v3/bill/116/hr/1503
- us · 116-hr-1503 · source updated 28 May 2025