PlainBillCongress, translated.Legislation. Context. Public interest.Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.
Congressional Research Service
Version 09 · 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.
People & committees
Rep. Cicilline, David N. [D-RI-1] · D–RI
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.
Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.
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.
Placed on the Union Calendar, Calendar No. 33.
Reported by the Committee on Judiciary. H. Rept. 116-55, Part II.
Reported by the Committee on Judiciary. H. Rept. 116-55, Part II.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-55, Part I.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-55, Part I.
Ordered to be Reported by Voice Vote.
Committee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended) by the Yeas and Nays: 50 - 0.
Committee Consideration and Mark-up Session Held.
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Subcommittee Consideration and Mark-up Session Held.
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Referred to the Subcommittee on Health.
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.
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.
Introduced in House
Introduced in House
Primary sources
Text links open the official source. We currently store references to these documents.
Source last updated: Dec 5, 2025. Consult Congress.gov for the current record.
AI Conversation Starters
Choose a perspective, copy a prompt, and paste it into your preferred AI. Each prompt includes the bill version and available official source links, and asks for counterarguments as well as supporting evidence.
Analyze H.R.965 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.
Examine H.R.965 through a progressive lens, focusing on fairness, access, economic inequality, and effects on vulnerable communities. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and distinguish stated goals from demonstrated outcomes.
Examine H.R.965 through a conservative lens, focusing on fiscal responsibility, institutional stability, federalism, and the scope of government. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and any provisions that challenge this perspective.
Examine H.R.965 through a civil-liberties and limited-government lens. Consider individual rights, privacy, voluntary choice, accountability, and government power. Explain tradeoffs, possible safeguards, and the strongest counterarguments without assuming the proposal is beneficial or harmful.