Bill Sponsor
House Bill 1503
116th Congress(2019-2020)
Orange Book Transparency Act of 2020
Became Law
Amendments
Became Law
Became Public Law 116-290 on Jan 5, 2021
Overview
Text
Introduced
Mar 5, 2019
Latest Action
Jan 5, 2021
Origin Chamber
House
Type
Bill
Bill
The primary form of legislative measure used to propose law. Depending on the chamber of origin, bills begin with a designation of either H.R. or S. Joint resolution is another form of legislative measure used to propose law.
Bill Number
1503
Congress
116
Policy Area
Health
Health
Primary focus of measure is science or practice of the diagnosis, treatment, and prevention of disease; health services administration and funding, including such programs as Medicare and Medicaid; health personnel and medical education; drug use and safety; health care coverage and insurance; health facilities. Measures concerning controlled substances and drug trafficking may fall under Crime and Law Enforcement policy area.
Sponsorship by Party
Democrat
Illinois
Democrat
California
Democrat
California
Democrat
California
Democrat
Massachusetts
Democrat
Minnesota
Democrat
New Jersey
Democrat
New Jersey
House Votes (1)
Senate Votes (1)
checkPassed on May 8, 2019
Question
On Motion to Suspend the Rules and Pass, as Amended
Status
Passed
Type
Roll Call Vote
Roll Call Vote
A vote that records the individual position of each Member who voted. Such votes occurring on the House floor (by the "yeas and nays" or by "recorded vote") are taken by electronic device. The Senate has no electronic voting system; in such votes, Senators answer "yea" or "nay" as the clerk calls each name aloud. Each vote is compiled by clerks and receives a roll call number (referenced in Congress.gov as a "Record Vote" [Senate] or "Roll no." [House]).
Roll Call Type
2/3 Yea-And-Nay
Roll Number
187
House Roll Call Votes
Summary

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.

Amendments (1)
Dec 07, 2020
Agreed to in Senate
1
Sponsorship
Senate Amendment 2693
In the nature of a substitute.
Agreed To
Public Record
Record Updated
Nov 1, 2022 5:03:26 PM