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H.R. 965 · 116th Congress

CREATES Act of 2019

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IntroducedPassed one chamberPassed both chambersBecame law (gold)Resolution agreed to (full, dark)Failed or vetoed (gray)

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Never voted on. It didn't reach a floor vote before the 116th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

Creating and Restoring Equal Access to Equivalent Samples Act of 2019 or the CREATES Act of 2019

What it does: CRS summary · Reported to House, Part II · May 10, 2019

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.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: CREATES Act of 2019

Also known as: Creating and Restoring Equal Access to Equivalent Samples Act of 2019

Latest action (May 16, 2019): Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.

Policy area: Health · Origin: House · Introduced: Feb 5, 2019

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.