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Bill116th CongressFiled Feb 5, 2019Health
H.R. 965

CREATES Act of 2019

Bill journey · stage 1 of 5

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What it doesSummary reported to house, part i (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.

What just happenedMay 16, 2019

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

Who’s behind it

Rep. Cicilline, David N. [D-RI-1](D-RI)Sponsor
68 cosponsors55 D13 R
Read on Congress.gov
68cosponsors2committees20actions7related bills5subjects
  1. May 16, 2019CommitteeH12210

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

    Judiciary Committee
  2. May 16, 2019Committee5000

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

    Judiciary Committee
  3. May 16, 2019FloorH8D000

    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.

  4. May 10, 2019CalendarsH12410

    Placed on the Union Calendar, Calendar No. 33.

  5. May 10, 2019CommitteeH12200

    Reported by the Committee on Judiciary. H. Rept. 116-55, Part II.

    Judiciary Committee
  6. May 10, 2019Committee5000

    Reported by the Committee on Judiciary. H. Rept. 116-55, Part II.

    Judiciary Committee
  7. May 10, 2019CommitteeH12200

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-55, Part I.

    Energy and Commerce Committee
  8. May 10, 2019Committee5000

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-55, Part I.

    Energy and Commerce Committee
  9. Apr 30, 2019Committee

    Ordered to be Reported by Voice Vote.

    Judiciary Committee
  10. Apr 30, 2019Committee

    Committee Consideration and Mark-up Session Held.

    Judiciary Committee
  11. Apr 3, 2019Committee

    Ordered to be Reported (Amended) by the Yeas and Nays: 50 - 0.

    Energy and Commerce Committee
  12. Apr 3, 2019Committee

    Committee Consideration and Mark-up Session Held.

    Energy and Commerce Committee
  13. Mar 27, 2019Committee

    Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .

    Health Subcommittee
  14. Mar 27, 2019Committee

    Subcommittee Consideration and Mark-up Session Held.

    Health Subcommittee
  15. Mar 22, 2019Committee

    Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.

    Administrative State, Regulatory Reform, and Antitrust Subcommittee
  16. Feb 6, 2019Committee

    Referred to the Subcommittee on Health.

    Health Subcommittee
  17. Feb 5, 2019IntroReferralH11100

    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.

    Judiciary Committee
  18. Feb 5, 2019IntroReferralH11100

    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.

    Energy and Commerce Committee
  19. Feb 5, 2019IntroReferralIntro-H

    Introduced in House

  20. Feb 5, 2019IntroReferral1000

    Introduced in House

Reported to House, Part IMay 10, 20198

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 IIMay 10, 20199

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.
Introduced in HouseFeb 5, 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.

CREATES Act of 2019 — Informed