CREATES Act of 2019
USA116th CongressHR-965| House
| Updated: 5/16/2019
David N. Cicilline
Democratic Representative
Rhode Island
Cosponsors (68)
Kim Schrier (Democratic)Donald Norcross (Democratic)F. James Sensenbrenner (Republican)Tom Cole (Republican)Gilbert Ray Cisneros (Democratic)Sylvia R. Garcia (Democratic)Chris Pappas (Democratic)Mark Meadows (Republican)Joseph P. Kennedy (Democratic)Abigail Davis Spanberger (Democratic)James R. Langevin (Democratic)Ben McAdams (Democratic)Ed Case (Democratic)Chrissy Houlahan (Democratic)Raul Ruiz (Democratic)Jefferson Van Drew (Republican)Joe Courtney (Democratic)David Scott (Democratic)Bobby L. Rush (Democratic)Debbie Dingell (Democratic)Steve Cohen (Democratic)Jennifer Wexton (Democratic)Doug Collins (Republican)Paul Tonko (Democratic)Angie Craig (Democratic)Jim Jordan (Republican)Scott Perry (Republican)David B. McKinley (Republican)Ro Khanna (Democratic)Greg Stanton (Democratic)Kurt Schrader (Democratic)John B. Larson (Democratic)David P. Joyce (Republican)Jim Cooper (Democratic)Rodney Davis (Republican)Doris O. Matsui (Democratic)Jerrold Nadler (Democratic)Theodore E. Deutch (Democratic)Anna G. Eshoo (Democratic)Lucy McBath (Democratic)Betty McCollum (Democratic)Sharice Davids (Democratic)Mike Gallagher (Republican)Daniel Lipinski (Democratic)Anthony Gonzalez (Republican)Abby Finkenauer (Democratic)Salud O. Carbajal (Democratic)Jamie Raskin (Democratic)Mike Quigley (Democratic)Sean Casten (Democratic)Debbie Mucarsel-Powell (Democratic)Janice D. Schakowsky (Democratic)Andy Kim (Democratic)Adam Smith (Democratic)Yvette D. Clarke (Democratic)Peter Welch (Democratic)Colin Z. Allred (Democratic)Ralph Norman (Republican)Jason Crow (Democratic)Frank Pallone (Democratic)Grace Meng (Democratic)Cheri Bustos (Democratic)Louie Gohmert (Republican)Lloyd Doggett (Democratic)Gerald E. Connolly (Democratic)Lauren Underwood (Democratic)Chellie Pingree (Democratic)Susan Wild (Democratic)
Administrative State, Regulatory Reform, and Antitrust Subcommittee, Health Subcommittee, Judiciary Committee, Energy and Commerce Committee
- 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
Introduced in House
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.
Latest Companion Bill Action
S 116-340Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 22.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Subcommittee Consideration and Mark-up Session Held.
Forwarded by Subcommittee to Full Committee (Amended) 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.
Ordered to be Reported by Voice Vote.
Placed on the Union Calendar, Calendar No. 33.
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.
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.
Health
Civil actions and liabilityDrug safety, medical device, and laboratory regulationLicensing and registrationsPrescription drugsProduct development and innovation
CREATES Act of 2019
USA116th CongressHR-965| House
| Updated: 5/16/2019
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.
Suggested Questions
Get AI-generated questions to help you understand this bill better
Timeline
Introduced in House
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.
Latest Companion Bill Action
S 116-340Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 22.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Subcommittee Consideration and Mark-up Session Held.
Forwarded by Subcommittee to Full Committee (Amended) 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.
Ordered to be Reported by Voice Vote.
Placed on the Union Calendar, Calendar No. 33.
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.
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.
David N. Cicilline
Democratic Representative
Rhode Island
Cosponsors (68)
Kim Schrier (Democratic)Donald Norcross (Democratic)F. James Sensenbrenner (Republican)Tom Cole (Republican)Gilbert Ray Cisneros (Democratic)Sylvia R. Garcia (Democratic)Chris Pappas (Democratic)Mark Meadows (Republican)Joseph P. Kennedy (Democratic)Abigail Davis Spanberger (Democratic)James R. Langevin (Democratic)Ben McAdams (Democratic)Ed Case (Democratic)Chrissy Houlahan (Democratic)Raul Ruiz (Democratic)Jefferson Van Drew (Republican)Joe Courtney (Democratic)David Scott (Democratic)Bobby L. Rush (Democratic)Debbie Dingell (Democratic)Steve Cohen (Democratic)Jennifer Wexton (Democratic)Doug Collins (Republican)Paul Tonko (Democratic)Angie Craig (Democratic)Jim Jordan (Republican)Scott Perry (Republican)David B. McKinley (Republican)Ro Khanna (Democratic)Greg Stanton (Democratic)Kurt Schrader (Democratic)John B. Larson (Democratic)David P. Joyce (Republican)Jim Cooper (Democratic)Rodney Davis (Republican)Doris O. Matsui (Democratic)Jerrold Nadler (Democratic)Theodore E. Deutch (Democratic)Anna G. Eshoo (Democratic)Lucy McBath (Democratic)Betty McCollum (Democratic)Sharice Davids (Democratic)Mike Gallagher (Republican)Daniel Lipinski (Democratic)Anthony Gonzalez (Republican)Abby Finkenauer (Democratic)Salud O. Carbajal (Democratic)Jamie Raskin (Democratic)Mike Quigley (Democratic)Sean Casten (Democratic)Debbie Mucarsel-Powell (Democratic)Janice D. Schakowsky (Democratic)Andy Kim (Democratic)Adam Smith (Democratic)Yvette D. Clarke (Democratic)Peter Welch (Democratic)Colin Z. Allred (Democratic)Ralph Norman (Republican)Jason Crow (Democratic)Frank Pallone (Democratic)Grace Meng (Democratic)Cheri Bustos (Democratic)Louie Gohmert (Republican)Lloyd Doggett (Democratic)Gerald E. Connolly (Democratic)Lauren Underwood (Democratic)Chellie Pingree (Democratic)Susan Wild (Democratic)
Administrative State, Regulatory Reform, and Antitrust Subcommittee, Health Subcommittee, Judiciary Committee, Energy and Commerce Committee
Health
Related Bills
- HR 116-1865: Further Consolidated Appropriations Act, 2020
- S 116-340: CREATES Act of 2019
- HR 116-3947: Competition Prescription Act of 2019
- HR 116-2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act
- S 116-1895: Lower Health Care Costs Act
- HR 116-19: Lower Costs, More Cures Act of 2019
- HR 116-987: Strengthening Health Care and Lowering Prescription Drug Costs 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