House Bill 965
116th Congress(2019-2020)
CREATES Act of 2019
Introduced
Introduced in House on Feb 5, 2019
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
965
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.
No House votes have been held for this bill.
Summary
Creating and Restoring Equal Access to Equivalent Samples Act of 2019 or the CREATES Act of 2019
This bill generally allows the developer of a drug or biological product, such as a generic or biosimilar version of a drug, to bring a civil action against the license holder of an approved medication if the holder refuses to make available sufficient quantities of the approved medication for the developer's testing. The bill also establishes affirmative defenses to such a civil action.
In addition, the bill authorizes drug manufacturers seeking Food and Drug Administration approval for a generic drug to use alternative methods to develop elements assure safe use of a drug.
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05/16/2019
Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.
05/16/2019
PERMISSION TO FILE SUPPLEMENTAL - Ms. Lofgren asked unanimous consent that Committee on the Judiciary be authorized to file a supplemental report on the bill, H.R. 965. Agreed to without objection.
05/10/2019
Placed on the Union Calendar, Calendar No. 33.
05/10/2019
Reported by the Committee on Judiciary. H. Rept. 116-55, Part II.
05/10/2019
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-55, Part I.
04/30/2019
Ordered to be Reported by Voice Vote.
04/30/2019
Committee Consideration and Mark-up Session Held.
04/03/2019
Ordered to be Reported (Amended) by the Yeas and Nays: 50 - 0.
04/03/2019
Committee Consideration and Mark-up Session Held.
03/27/2019
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
03/27/2019
Subcommittee Consideration and Mark-up Session Held.
03/22/2019
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
02/06/2019
Referred to the Subcommittee on Health.
02/05/2019
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
02/05/2019
Introduced in House
Public Record
Record Updated
Nov 1, 2022 3:32:55 PM