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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
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This bill died when the 116th Congress ended
It never became law before the 116th Congress (2019–2020) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 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
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 Plain-English summary Congressional Research Service

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 May 16, 2019

Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.

 Related & companion bills 7
  • HR 19 Related bill Lower Costs, More Cures Act of 2019
  • HR 987 Related bill Strengthening Health Care and Lowering Prescription Drug Costs Act
  • HR 1865 Related bill Further Consolidated Appropriations Act, 2020
  • HR 2700 Related bill Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act
  • S 1895 Related bill Lower Health Care Costs Act
  • S 340 Identical bill CREATES Act of 2019
  • HR 3947 Related bill Competition Prescription Act of 2019
 Bill text 2 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 4
 Cosponsors 45
All 45 Democratic 36 Republican 6
D
Garcia, Sylvia R.
Texas · May 10, 2019
 D
Meng, Grace
New York · May 10, 2019
 D
Underwood, Lauren
Illinois · May 10, 2019
 D
Cisneros, Gilbert Ray
California · May 9, 2019
 D
Carbajal, Salud O.
California · May 8, 2019
 D
Smith, Adam
Washington · May 8, 2019
 D
Case, Ed
Hawaii · May 7, 2019
 D
Casten, Sean
Illinois · May 7, 2019
 D
Houlahan, Chrissy
Pennsylvania · May 7, 2019
 R
Joyce, David P.
Ohio · May 7, 2019
 D
Khanna, Ro
California · May 7, 2019
 R
Norman, Ralph
South Carolina · May 7, 2019
 D
Pingree, Chellie
Maine · May 7, 2019
 D
Schrier, Kim
Washington · May 7, 2019
 D
Kim, Andy
New Jersey · May 1, 2019
 D
Cohen, Steve
Tennessee · Apr 30, 2019
 R
Jordan, Jim
Ohio · Apr 30, 2019
 D
Raskin, Jamie
Maryland · Apr 29, 2019
 D
Stanton, Greg
Arizona · Apr 29, 2019
 D
McBath, Lucy
Georgia · Apr 25, 2019
 D
Quigley, Mike
Illinois · Apr 22, 2019
 D
Davids, Sharice
Kansas · Apr 18, 2019
 D
Norcross, Donald
New Jersey · Apr 18, 2019
 D
Pappas, Chris
New Hampshire · Apr 18, 2019
Schrader, Kurt
· Apr 10, 2019
 D
Larson, John B.
Connecticut · Apr 9, 2019
 D
Crow, Jason
Colorado · Apr 8, 2019
 D
Schakowsky, Janice D.
Illinois · Apr 8, 2019
 D
Courtney, Joe
Connecticut · Apr 4, 2019
 D
Clarke, Yvette D.
New York · Apr 2, 2019
 D
Tonko, Paul
New York · Apr 1, 2019
 R
Van Drew, Jefferson
New Jersey · Apr 1, 2019
 D
Craig, Angie
Minnesota · Mar 27, 2019
 D
Matsui, Doris O.
California · Mar 27, 2019
 D
Dingell, Debbie
Michigan · Mar 26, 2019
 D
Pallone, Frank
New Jersey · Mar 26, 2019
 R
Perry, Scott
Pennsylvania · Mar 26, 2019
 D
Ruiz, Raul
California · Mar 26, 2019
 D
McCollum, Betty
Minnesota · Mar 18, 2019
 R
Cole, Tom
Oklahoma · Mar 11, 2019
 D
Doggett, Lloyd
Texas · Mar 11, 2019
Lipinski, Daniel
· Mar 11, 2019
Collins, Doug
· Feb 5, 2019
 D
Nadler, Jerrold
New York · Feb 5, 2019
 D
Welch, Peter
Vermont · Feb 5, 2019
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 965: CREATES Act of 2019. 116th Congress. Open America. https://openamerica.io/bill/116-HR-965/
MLA
"H.R. 965: CREATES Act of 2019." 116th Congress, 2026, Open America, https://openamerica.io/bill/116-HR-965/.
Bluebook (legal)
H.R. 965, 116th Cong. (2026), https://openamerica.io/bill/116-HR-965/.
Markdown link
[H.R. 965: CREATES Act of 2019](https://openamerica.io/bill/116-HR-965/)
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