Latest Action
Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.
5/16/2019 • House
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.Reported to House, Part II • 5/10/2019
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Bill Journey
Originated in the House
Introduced
February 5, 2019
Committee Review
March 27, 2019
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Floor Debate
Passed Chamber
Other Chamber
President
Enacted into Law
Text Versions (2)
Committee Reports (3)
Related Bills (7)
H.R. 19
Lower Costs, More Cures Act of 2019
H.R. 987
Strengthening Health Care and Lowering Prescription Drug Costs Act
H.R. 1865
Further Consolidated Appropriations Act, 2020
H.R. 2700
Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act
S. 1895
Lower Health Care Costs Act
S. 340
CREATES Act of 2019
H.R. 3947
Competition Prescription Act of 2019