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HOUSE 1503116th CongressBecame Public Law No: 116-290.

Orange Book Transparency Act of 2020

Last Action
1/5/2021

Actions

  • 2021-01-05Became Public Law No: 116-290.
  • 2021-01-05Became Public Law No: 116-290.
  • 2021-01-05Signed by President.
  • 2021-01-05Signed by President.
  • 2020-12-24Presented to President.
  • 2020-12-24Presented to President.
  • 2020-12-10Motion to reconsider laid on the table Agreed to without objection.
  • 2020-12-10On motion that the House agree to the Senate amendment Agreed to without objection. (text: CR H7130-7131)
  • 2020-12-10Resolving differences -- House actions: On motion that the House agree to the Senate amendment Agreed to without objection.(text: CR H7130-7131)
  • 2020-12-10Mrs. 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)
  • 2020-12-10Mrs. Dingell asked unanimous consent that the House agree to the Senate amendment.
  • 2020-12-08Message on Senate action sent to the House.
  • 2020-12-07Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S7242-7243)
  • 2020-12-07Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.(text of amendment in the nature of a substitute: CR S7242-7243)
  • 2020-12-07Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.

Showing 15 of 20 actions. Full history on Congress.gov.

CRS Summary

As of 2021-01-05 (49)

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.

Cosponsors (13)

  • Raul Ruiz (D-CA)
  • BOBBY RUSH (D-IL)
  • FRANK PALLONE (D-NJ)
  • Debbie Dingell (D-MI)
  • ANNA ESHOO (D-CA)
  • Joseph Kennedy (D-MA)
  • Doris Matsui (D-CA)
  • Angie Craig (D-MN)
  • Yvette Clarke (D-NY)
  • Jefferson Van Drew (D-NJ)
  • GREG WALDEN (R-OR)
  • JANICE SCHAKOWSKY (D-IL)
  • Debbie Mucarsel-Powell (D-FL)

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

Became law: Pub. L. 116-290

Read on Congress.gov

Sourced from Congress.gov (public domain).

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.