Orange Book Transparency Act of 2020 became law 672 days after introduction, with cosponsors from both parties
IntroducedMar 5, 2019
ReportedApr 3, 2019
Passed one chamberMay 8, 2019
Passed bothDec 7, 2020
LawJan 5, 2021
What it changes · CRS summary
Written by the Congressional Research Service [2]. 91 words.
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.
Context
- Committees
- House Energy and Commerce Committee
Senate Health, Education, Labor, and Pensions Committee - Policy area
- Health: 122 of 9,357 bills became law, 113th–118th (1.3%)
- Sponsor
- 6 of 142 bills enacted since 2013
- Text versions
- 7, from enrolled bill to public law · 1,977 words
- Subjects
- Administrative law and regulatory proceduresCongressional oversightDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Government information and archivesIntellectual property +1 more
- Latest action
- Jan 5, 2021: Became Public Law No: 116-290.
- Records
- Congress.gov · Bill text
Exhibit 1Passage odds band at each stage, rated when the bill reached it [4]
Related bills · 2
Each bill appears once, under its strongest link. 2 in all.
Related, per CRS or House · 2
- 116th H.R. 1503 Orange Book Transparency Act of 2020 D · Law
- 116th H.R. 19 Lower Costs, More Cures Act of 2019 R · Introduced
Exhibit 2Articles naming the bill per day, last 90 days, US sources [3]