Legis Daily

CREATES Act of 2019

USA116th CongressS-340| Senate 
| Updated: 2/6/2019
Patrick J. Leahy

Patrick J. Leahy

Democratic Senator

Vermont

Cosponsors (41)
Joni Ernst (Republican)Jeanne Shaheen (Democratic)Mike Braun (Republican)Mazie K. Hirono (Democratic)Margaret Wood Hassan (Democratic)Dianne Feinstein (Democratic)Richard J. Durbin (Democratic)Edward J. Markey (Democratic)Jack Reed (Democratic)Mike Lee (Republican)Kirsten E. Gillibrand (Democratic)Todd Young (Republican)Thomas R. Carper (Democratic)Angus S. King (Independent)Tom Cotton (Republican)Amy Klobuchar (Democratic)Rand Paul (Republican)Martha McSally (Republican)Sheldon Whitehouse (Democratic)Jacky Rosen (Democratic)Mike Rounds (Republican)Ted Cruz (Republican)Chris Van Hollen (Democratic)Kevin Cramer (Republican)Jon Tester (Democratic)Debbie Stabenow (Democratic)John Kennedy (Republican)Deb Fischer (Republican)Tina Smith (Democratic)Sherrod Brown (Democratic)Tammy Baldwin (Democratic)Cory A. Booker (Democratic)Robert Menendez (Democratic)Susan M. Collins (Republican)Chuck Grassley (Republican)Gary C. Peters (Democratic)Steve Daines (Republican)John Hoeven (Republican)Richard Blumenthal (Democratic)Lisa Murkowski (Republican)Shelley Moore Capito (Republican)
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.
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Timeline

Bill from Previous Congress

S 115-974
CREATES Act of 2018
Feb 5, 2019
Introduced in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time. (Sponsor introductory remarks on measure: CR S868-869)
Feb 5, 2019
Introduced in Senate
Feb 6, 2019
Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 22.
May 16, 2019

Latest Companion Bill Action

HR 116-965
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.
  • Bill from Previous Congress

    S 115-974
    CREATES Act of 2018


  • February 5, 2019
    Introduced in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time. (Sponsor introductory remarks on measure: CR S868-869)


  • February 5, 2019
    Introduced in Senate


  • February 6, 2019
    Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 22.


  • May 16, 2019

    Latest Companion Bill Action

    HR 116-965
    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.

Health

Related Bills

  • HR 116-965: CREATES Act of 2019
  • HR 116-2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act
Civil actions and liabilityDrug safety, medical device, and laboratory regulationLicensing and registrationsPrescription drugsProduct development and innovation

CREATES Act of 2019

USA116th CongressS-340| Senate 
| Updated: 2/6/2019
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

S 115-974
CREATES Act of 2018
Feb 5, 2019
Introduced in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time. (Sponsor introductory remarks on measure: CR S868-869)
Feb 5, 2019
Introduced in Senate
Feb 6, 2019
Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 22.
May 16, 2019

Latest Companion Bill Action

HR 116-965
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.
  • Bill from Previous Congress

    S 115-974
    CREATES Act of 2018


  • February 5, 2019
    Introduced in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time. (Sponsor introductory remarks on measure: CR S868-869)


  • February 5, 2019
    Introduced in Senate


  • February 6, 2019
    Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 22.


  • May 16, 2019

    Latest Companion Bill Action

    HR 116-965
    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.
Patrick J. Leahy

Patrick J. Leahy

Democratic Senator

Vermont

Cosponsors (41)
Joni Ernst (Republican)Jeanne Shaheen (Democratic)Mike Braun (Republican)Mazie K. Hirono (Democratic)Margaret Wood Hassan (Democratic)Dianne Feinstein (Democratic)Richard J. Durbin (Democratic)Edward J. Markey (Democratic)Jack Reed (Democratic)Mike Lee (Republican)Kirsten E. Gillibrand (Democratic)Todd Young (Republican)Thomas R. Carper (Democratic)Angus S. King (Independent)Tom Cotton (Republican)Amy Klobuchar (Democratic)Rand Paul (Republican)Martha McSally (Republican)Sheldon Whitehouse (Democratic)Jacky Rosen (Democratic)Mike Rounds (Republican)Ted Cruz (Republican)Chris Van Hollen (Democratic)Kevin Cramer (Republican)Jon Tester (Democratic)Debbie Stabenow (Democratic)John Kennedy (Republican)Deb Fischer (Republican)Tina Smith (Democratic)Sherrod Brown (Democratic)Tammy Baldwin (Democratic)Cory A. Booker (Democratic)Robert Menendez (Democratic)Susan M. Collins (Republican)Chuck Grassley (Republican)Gary C. Peters (Democratic)Steve Daines (Republican)John Hoeven (Republican)Richard Blumenthal (Democratic)Lisa Murkowski (Republican)Shelley Moore Capito (Republican)

Health

Related Bills

  • HR 116-965: CREATES Act of 2019
  • HR 116-2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Civil actions and liabilityDrug safety, medical device, and laboratory regulationLicensing and registrationsPrescription drugsProduct development and innovation