Health, Education, Labor, and Pensions Committee, Health Subcommittee, Energy and Commerce Committee
Introduced
In Committee
On Floor
Passed Chamber
Enacted
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.
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Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Subcommittee Consideration and Mark-up Session Held.
Committee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended) by Voice Vote.
Placed on the Union Calendar, Calendar No. 25.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-47.
Ms. Eshoo moved to suspend the rules and pass the bill, as amended.
Considered under suspension of the rules. (consideration: CR H3486-3488)
DEBATE - The House proceeded with forty minutes of debate on H.R. 1503.
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.
Considered as unfinished business. (consideration: CR H3491)
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)
Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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.
Measure laid before Senate by unanimous consent. (consideration: CR S7244)
Message on Senate action sent to the House.
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 that the House agree to the Senate amendment.
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)
On motion that the House agree to the Senate amendment Agreed to without objection. (text: CR H7130-7131)
Motion to reconsider laid on the table Agreed to without objection.
Presented to President.
Signed by President.
Became Public Law No: 116-290.
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Subcommittee Consideration and Mark-up Session Held.
Committee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended) by Voice Vote.
Placed on the Union Calendar, Calendar No. 25.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-47.
Ms. Eshoo moved to suspend the rules and pass the bill, as amended.
Considered under suspension of the rules. (consideration: CR H3486-3488)
DEBATE - The House proceeded with forty minutes of debate on H.R. 1503.
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.
Considered as unfinished business. (consideration: CR H3491)
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)
Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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.
Measure laid before Senate by unanimous consent. (consideration: CR S7244)
Message on Senate action sent to the House.
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 that the House agree to the Senate amendment.
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)
On motion that the House agree to the Senate amendment Agreed to without objection. (text: CR H7130-7131)
Motion to reconsider laid on the table Agreed to without objection.
Administrative law and regulatory proceduresCongressional oversightDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Government information and archivesIntellectual propertyPrescription drugs
Orange Book Transparency Act of 2020
USA116th CongressHR-1503| House
| Updated: 1/5/2021
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.
Get AI-generated questions to help you understand this bill better
Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Subcommittee Consideration and Mark-up Session Held.
Committee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended) by Voice Vote.
Placed on the Union Calendar, Calendar No. 25.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-47.
Ms. Eshoo moved to suspend the rules and pass the bill, as amended.
Considered under suspension of the rules. (consideration: CR H3486-3488)
DEBATE - The House proceeded with forty minutes of debate on H.R. 1503.
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.
Considered as unfinished business. (consideration: CR H3491)
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)
Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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.
Measure laid before Senate by unanimous consent. (consideration: CR S7244)
Message on Senate action sent to the House.
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 that the House agree to the Senate amendment.
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)
On motion that the House agree to the Senate amendment Agreed to without objection. (text: CR H7130-7131)
Motion to reconsider laid on the table Agreed to without objection.
Presented to President.
Signed by President.
Became Public Law No: 116-290.
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Subcommittee Consideration and Mark-up Session Held.
Committee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended) by Voice Vote.
Placed on the Union Calendar, Calendar No. 25.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-47.
Ms. Eshoo moved to suspend the rules and pass the bill, as amended.
Considered under suspension of the rules. (consideration: CR H3486-3488)
DEBATE - The House proceeded with forty minutes of debate on H.R. 1503.
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.
Considered as unfinished business. (consideration: CR H3491)
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)
Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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.
Measure laid before Senate by unanimous consent. (consideration: CR S7244)
Message on Senate action sent to the House.
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 that the House agree to the Senate amendment.
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)
On motion that the House agree to the Senate amendment Agreed to without objection. (text: CR H7130-7131)
Motion to reconsider laid on the table Agreed to without objection.
Administrative law and regulatory proceduresCongressional oversightDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Government information and archivesIntellectual propertyPrescription drugs