HR 965
116th Congress
House
Health
Civil actions and liability
Drug safety, medical device, and laboratory regulation
Licensing and registrations
Prescription drugs
Product development and innovation
CREATES Act of 2019
Introduced: February 5, 2019
See on congress.gov
Everywhere this bill has been
15 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
May 16, 2019
Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.
May 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.
May 10, 2019
Placed on the Union Calendar, Calendar No. 33.
May 10, 2019
Reported by the Committee on Judiciary. H. Rept. 116-55, Part II.
May 10, 2019
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-55, Part I.
Apr 30, 2019
Ordered to be Reported by Voice Vote.
Apr 30, 2019
Committee Consideration and Mark-up Session Held.
Apr 3, 2019
Ordered to be Reported (Amended) by the Yeas and Nays: 50 - 0.
Apr 3, 2019
Committee Consideration and Mark-up Session Held.
Mar 27, 2019
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Mar 27, 2019
Subcommittee Consideration and Mark-up Session Held.
Mar 22, 2019
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Feb 6, 2019
Referred to the Subcommittee on Health.
Feb 5, 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.
Feb 5, 2019
Introduced in House
Plain-English 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.
What's happening now
Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.