HR 965 · 116th Congress · Health
CREATES Act of 2019
Bill Progress
✓
Introduced✓
Committee3
House Vote4
Senate5
EnactedLatest: Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.(2019-05-16)
Plain Language Summary
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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.…
Summarized by Claude AI · Non-partisan · For informational purposes only
CBO Cost Estimate
Congressional Budget OfficeH.R. 965, CREATES Act of 2019
Apr 30, 2019As ordered reported by the House Committee on Energy and Commerce on April 3, 2019
Full CBO report ↗H.R. 965, CREATES Act of 2019
May 9, 2019As ordered reported by the House Committee on the Judiciary on April 30, 2019
Full CBO report ↗Official non-partisan budget analysis by the Congressional Budget Office
Cosponsors (20)
13 Democrats7 Republicans