Congress 116 - HR 1503 - Orange Book Transparency Act of 2020

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Topics

Administrative law and regulatory procedures Congressional oversight Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Government information and archives Health Intellectual property Prescription drugs

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Summary

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.

Actions

Jan 5, 2021

Became Public Law No: 116-290.
Jan 5, 2021

Signed by President.
Dec 24, 2020

Presented to President.
Dec 10, 2020

Motion to reconsider laid on the table Agreed to without objection.
Dec 10, 2020

On motion that the House agree to the Senate amendment Agreed to without objection. (text: CR H7130-7131)
Dec 10, 2020

Resolving differences -- House actions: On motion that the House agree to the Senate amendment Agreed to without objection.(text: CR H7130-7131)
Dec 10, 2020

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)
Dec 10, 2020

Mrs. Dingell asked unanimous consent that the House agree to the Senate amendment.
Dec 8, 2020

Message on Senate action sent to the House.
Dec 7, 2020

Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S7242-7243)
Dec 7, 2020

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)
Dec 7, 2020

Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
Dec 7, 2020

Measure laid before Senate by unanimous consent. (consideration: CR S7244)
May 9, 2019

Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
May 8, 2019

DEBATE - The House proceeded with forty minutes of debate on H.R. 1503.
May 8, 2019

Considered under suspension of the rules. (consideration: CR H3486-3488)
May 8, 2019

Ms. Eshoo moved to suspend the rules and pass the bill, as amended.
May 8, 2019

Motion to reconsider laid on the table Agreed to without objection.
May 8, 2019

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)
May 8, 2019

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)
May 8, 2019

Considered as unfinished business. (consideration: CR H3491)
May 8, 2019

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.
May 2, 2019

Placed on the Union Calendar, Calendar No. 25.
May 2, 2019

Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-47.
Apr 3, 2019

Ordered to be Reported (Amended) by Voice Vote.
Apr 3, 2019

Committee Consideration and Mark-up Session Held.
Mar 27, 2019

Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Mar 27, 2019

Subcommittee Consideration and Mark-up Session Held.
Mar 6, 2019

Referred to the Subcommittee on Health.
Mar 5, 2019

Referred to the House Committee on Energy and Commerce.
Mar 5, 2019

Introduced in House

Amendments

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