Orange Book Transparency Act of 2020

Bill: 116-hr-1503
Sponsor: Rep. Kelly, Robin L. [D-IL-2]
Introduced: 2019-03-05 in the House
Policy area: Health
Subjects: Administrative law and regulatory procedures
Congressional oversight
Drug safety, medical device, and laboratory regulation
Food and Drug Administration (FDA)
Government information and archives
Intellectual property
Prescription drugs

Summary:
action_date: 2019-03-05
text: 

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.

action_date: 2021-01-05
text: 

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.


Legislative actions:
action_date: 2021-01-05
text: Became Public Law No: 116-290.
action_date: 2021-01-05
text: Became Public Law No: 116-290.
action_date: 2021-01-05
text: Signed by President.
action_date: 2021-01-05
text: Signed by President.
action_date: 2020-12-24
text: Presented to President.
action_date: 2020-12-24
text: Presented to President.
action_date: 2020-12-10
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2020-12-10
text: On motion that the House agree to the Senate amendment Agreed to without objection. (text: CR H7130-7131)
action_date: 2020-12-10
text: Resolving differences -- House actions: On motion that the House agree to the Senate amendment Agreed to without objection.(text: CR H7130-7131)
action_date: 2020-12-10
text: 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)
action_date: 2020-12-10
text: Mrs. Dingell asked unanimous consent that the House agree to the Senate amendment.
action_date: 2020-12-08
text: Message on Senate action sent to the House.
action_date: 2020-12-07
text: Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S7242-7243)
action_date: 2020-12-07
text: 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)
action_date: 2020-12-07
text: Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
action_date: 2020-12-07
text: Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
action_date: 2020-12-07
text: Measure laid before Senate by unanimous consent. (consideration: CR S7244)
action_date: 2019-05-09
text: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2019-05-08
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2019-05-08
text: 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)
action_date: 2019-05-08
text: 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)
action_date: 2019-05-08
text: Considered as unfinished business. (consideration: CR H3491)
action_date: 2019-05-08
text: 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.
action_date: 2019-05-08
text: DEBATE - The House proceeded with forty minutes of debate on H.R. 1503.
action_date: 2019-05-08
text: Considered under suspension of the rules. (consideration: CR H3486-3488)
action_date: 2019-05-08
text: Ms. Eshoo moved to suspend the rules and pass the bill, as amended.
action_date: 2019-05-02
text: Placed on the Union Calendar, Calendar No. 25.
action_date: 2019-05-02
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-47.
action_date: 2019-05-02
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-47.
action_date: 2019-04-03
text: Ordered to be Reported (Amended) by Voice Vote.
action_date: 2019-04-03
text: Committee Consideration and Mark-up Session Held.
action_date: 2019-03-27
text: Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
action_date: 2019-03-27
text: Subcommittee Consideration and Mark-up Session Held.
action_date: 2019-03-06
text: Referred to the Subcommittee on Health.
action_date: 2019-03-05
text: Referred to the House Committee on Energy and Commerce.
action_date: 2019-03-05
text: Introduced in House
action_date: 2019-03-05
text: Introduced in House

Enacted as: number: 116-290