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