Legis Daily

Orange Book Transparency Act of 2020

USA116th CongressHR-1503| House 
| Updated: 1/5/2021
Robin L. Kelly

Robin L. Kelly

Democratic Representative

Illinois

Cosponsors (13)
Joseph P. Kennedy (Democratic)Raul Ruiz (Democratic)Jefferson Van Drew (Republican)Bobby L. Rush (Democratic)Greg Walden (Republican)Debbie Dingell (Democratic)Angie Craig (Democratic)Doris O. Matsui (Democratic)Anna G. Eshoo (Democratic)Debbie Mucarsel-Powell (Democratic)Janice D. Schakowsky (Democratic)Yvette D. Clarke (Democratic)Frank Pallone (Democratic)

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.

Bill Text Versions

View Text
7 versions available

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Mar 5, 2019
Introduced in House
Mar 5, 2019
Referred to the House Committee on Energy and Commerce.
Mar 6, 2019
Referred to the Subcommittee on Health.
Mar 27, 2019
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Mar 27, 2019
Subcommittee Consideration and Mark-up Session Held.
Apr 3, 2019
Committee Consideration and Mark-up Session Held.
Apr 3, 2019
Ordered to be Reported (Amended) by Voice Vote.
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.
May 8, 2019
Ms. Eshoo moved to suspend the rules and pass the bill, as amended.
May 8, 2019
Considered under suspension of the rules. (consideration: CR H3486-3488)
May 8, 2019
DEBATE - The House proceeded with forty minutes of debate on H.R. 1503.
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 8, 2019
Considered as unfinished business. (consideration: CR H3491)
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)
View Vote
May 8, 2019
Motion to reconsider laid on the table Agreed to without objection.
May 9, 2019
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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)
Dec 8, 2020
Message on Senate action sent to the House.
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 that the House agree to the Senate amendment.
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
On motion that the House agree to the Senate amendment Agreed to without objection. (text: CR H7130-7131)
Dec 10, 2020
Motion to reconsider laid on the table Agreed to without objection.
Dec 24, 2020
Presented to President.
Jan 5, 2021
Signed by President.
Jan 5, 2021
Became Public Law No: 116-290.
  • March 5, 2019
    Introduced in House


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


  • March 6, 2019
    Referred to the Subcommittee on Health.


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


  • March 27, 2019
    Subcommittee Consideration and Mark-up Session Held.


  • April 3, 2019
    Committee Consideration and Mark-up Session Held.


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


  • 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.


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


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


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


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


  • 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)
    View Vote


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


  • May 9, 2019
    Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


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


  • December 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)


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


  • December 7, 2020
    Measure laid before Senate by unanimous consent. (consideration: CR S7244)


  • December 8, 2020
    Message on Senate action sent to the House.


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


  • December 10, 2020
    Mrs. Dingell asked unanimous consent that the House agree to the Senate amendment.


  • December 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)


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


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


  • December 24, 2020
    Presented to President.


  • January 5, 2021
    Signed by President.


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

Health

Related Bills

  • HR 116-19: Lower Costs, More Cures Act of 2019
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.

Bill Text Versions

View Text
7 versions available

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Mar 5, 2019
Introduced in House
Mar 5, 2019
Referred to the House Committee on Energy and Commerce.
Mar 6, 2019
Referred to the Subcommittee on Health.
Mar 27, 2019
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Mar 27, 2019
Subcommittee Consideration and Mark-up Session Held.
Apr 3, 2019
Committee Consideration and Mark-up Session Held.
Apr 3, 2019
Ordered to be Reported (Amended) by Voice Vote.
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.
May 8, 2019
Ms. Eshoo moved to suspend the rules and pass the bill, as amended.
May 8, 2019
Considered under suspension of the rules. (consideration: CR H3486-3488)
May 8, 2019
DEBATE - The House proceeded with forty minutes of debate on H.R. 1503.
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 8, 2019
Considered as unfinished business. (consideration: CR H3491)
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)
View Vote
May 8, 2019
Motion to reconsider laid on the table Agreed to without objection.
May 9, 2019
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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)
Dec 8, 2020
Message on Senate action sent to the House.
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 that the House agree to the Senate amendment.
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
On motion that the House agree to the Senate amendment Agreed to without objection. (text: CR H7130-7131)
Dec 10, 2020
Motion to reconsider laid on the table Agreed to without objection.
Dec 24, 2020
Presented to President.
Jan 5, 2021
Signed by President.
Jan 5, 2021
Became Public Law No: 116-290.
  • March 5, 2019
    Introduced in House


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


  • March 6, 2019
    Referred to the Subcommittee on Health.


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


  • March 27, 2019
    Subcommittee Consideration and Mark-up Session Held.


  • April 3, 2019
    Committee Consideration and Mark-up Session Held.


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


  • 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.


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


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


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


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


  • 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)
    View Vote


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


  • May 9, 2019
    Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


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


  • December 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)


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


  • December 7, 2020
    Measure laid before Senate by unanimous consent. (consideration: CR S7244)


  • December 8, 2020
    Message on Senate action sent to the House.


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


  • December 10, 2020
    Mrs. Dingell asked unanimous consent that the House agree to the Senate amendment.


  • December 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)


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


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


  • December 24, 2020
    Presented to President.


  • January 5, 2021
    Signed by President.


  • January 5, 2021
    Became Public Law No: 116-290.
Robin L. Kelly

Robin L. Kelly

Democratic Representative

Illinois

Cosponsors (13)
Joseph P. Kennedy (Democratic)Raul Ruiz (Democratic)Jefferson Van Drew (Republican)Bobby L. Rush (Democratic)Greg Walden (Republican)Debbie Dingell (Democratic)Angie Craig (Democratic)Doris O. Matsui (Democratic)Anna G. Eshoo (Democratic)Debbie Mucarsel-Powell (Democratic)Janice D. Schakowsky (Democratic)Yvette D. Clarke (Democratic)Frank Pallone (Democratic)

Health, Education, Labor, and Pensions Committee, Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • HR 116-19: Lower Costs, More Cures Act of 2019
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresCongressional oversightDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Government information and archivesIntellectual propertyPrescription drugs