United States · Bill · HR
H.R. 965 (116th)
CREATES Act of 2019
Introduced
5 February 2019
Last action
16 May 2019 · Passed
Status
Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.
Sponsors
Rep. Cicilline, David N. [D-RI-1], Rep. Sensenbrenner, F. James, Jr. [R-WI-5], Rep. Nadler, Jerrold [D-NY-12], Rep. Collins, Doug [R-GA-9], Sen. Welch, Peter [D-VT], Rep. McKinley, David B. [R-WV-1], Rep. Meadows, Mark [R-NC-11], Rep. Finkenauer, Abby [D-IA-1], Rep. Doggett, Lloyd [D-TX-37], Rep. Cole, Tom [R-OK-4], Rep. Gallagher, Mike [R-WI-8], Rep. Lipinski, Daniel [D-IL-3], Rep. Rush, Bobby L. [D-IL-1], Rep. McCollum, Betty [D-MN-4], Rep. Pallone, Frank [D-NJ-6], Rep. Perry, Scott [R-PA-10], Rep. Ruiz, Raul [D-CA-25], Rep. Dingell, Debbie [D-MI-6], Rep. Eshoo, Anna G. [D-CA-18], Rep. Matsui, Doris O. [D-CA-7], Rep. Craig, Angie [D-MN-2], Rep. Tonko, Paul [D-NY-20], Rep. Gohmert, Louie [R-TX-1], Rep. Van Drew, Jefferson [R-NJ-2], Rep. Clarke, Yvette D. [D-NY-9], Rep. Courtney, Joe [D-CT-2], Colin Allred, Rep. Schakowsky, Janice D. [D-IL-9], Rep. Crow, Jason [D-CO-6], Anthony Gonzalez, Rep. Larson, John B. [D-CT-1], Rep. McAdams, Ben [D-UT-4], Rep. Schrader, Kurt [D-OR-5], Rep. Davis, Rodney [R-IL-13], Rep. Pappas, Chris [D-NH-1], Rep. Kennedy, Joseph P., III [D-MA-4], Rep. Davids, Sharice [D-KS-3], Rep. Norcross, Donald [D-NJ-1], Rep. Spanberger, Abigail Davis [D-VA-7], Rep. Quigley, Mike [D-IL-5], Rep. Deutch, Theodore E. [D-FL-22], Rep. Langevin, James R. [D-RI-2], Rep. Cooper, Jim [D-TN-5], Rep. McBath, Lucy [D-GA-6], Rep. Raskin, Jamie [D-MD-8], Rep. Mucarsel-Powell, Debbie [D-FL-26], Rep. Stanton, Greg [D-AZ-4], Rep. Jordan, Jim [R-OH-4]
Subjects
Healthcare
Source updated
5 December 2025
Summary
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.
This text is taken from the official record. PoliticalRepo does not editorialize.
Timeline
5 February 2019
Introduced
Introduced in House
Source: IntroReferral
5 February 2019
Introduced
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.
Source: IntroReferral
5 February 2019
Introduced
Introduced in House
Source: IntroReferral
6 February 2019
Referred
Referred to the Subcommittee on Health.
Source: Committee
22 March 2019
Referred
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Source: Committee
27 March 2019
Committee
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Source: Committee
27 March 2019
Committee
Subcommittee Consideration and Mark-up Session Held.
Source: Committee
3 April 2019
Committee
Committee Consideration and Mark-up Session Held.
Source: Committee
3 April 2019
Vote
Ordered to be Reported (Amended) by the Yeas and Nays: 50 - 0.
Source: Committee
30 April 2019
Reported
Ordered to be Reported by Voice Vote.
Source: Committee
30 April 2019
Committee
Committee Consideration and Mark-up Session Held.
Source: Committee
10 May 2019
Reported
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-55, Part I.
Source: Committee
10 May 2019
Calendars
Placed on the Union Calendar, Calendar No. 33.
Source: Calendars
10 May 2019
Reported
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-55, Part I.
Source: Committee
16 May 2019
Committee
Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.
Source: Committee
16 May 2019
Committee
Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.
Source: Committee
16 May 2019
Passed
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.
Source: Floor
Votes
No vote records are attached yet.
Versions
- Reported in House · 10 May 2019 · Download file
- Introduced in House · 5 February 2019 · Download file
Documents
7 official files
Reported in House (text)
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Reported in House (text)
Reported in House · EN · 10 May 2019
Reported in House (PDF)
Reported in House · EN · 10 May 2019
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Reported to House, Part II
summary · EN · 10 May 2019
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Reported to House, Part I
summary · EN · 10 May 2019
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Introduced in House (text)
Introduced in House · EN · 5 February 2019
ViewDownloadOpen at official source
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Introduced in House (PDF)
Introduced in House · EN · 5 February 2019
ViewDownloadOpen at official source
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.
Introduced in House
summary · EN · 5 February 2019
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.
Sponsors
- Rep. Cicilline, David N. [D-RI-1] · D · Sponsor
- Rep. Sensenbrenner, F. James, Jr. [R-WI-5] · R · Sponsor
- Rep. Nadler, Jerrold [D-NY-12] · D · Sponsor
- Rep. Collins, Doug [R-GA-9] · R · Sponsor
- Sen. Welch, Peter [D-VT] · D · Sponsor
- Rep. McKinley, David B. [R-WV-1] · R · Sponsor
- Rep. Meadows, Mark [R-NC-11] · R · Cosponsor
- Rep. Finkenauer, Abby [D-IA-1] · D · Cosponsor
- Rep. Doggett, Lloyd [D-TX-37] · D · Cosponsor
- Rep. Cole, Tom [R-OK-4] · R · Cosponsor
- Rep. Gallagher, Mike [R-WI-8] · R · Cosponsor
- Rep. Lipinski, Daniel [D-IL-3] · D · Cosponsor
- Rep. Rush, Bobby L. [D-IL-1] · D · Cosponsor
- Rep. McCollum, Betty [D-MN-4] · D · Cosponsor
- Rep. Pallone, Frank [D-NJ-6] · D · Cosponsor
- Rep. Perry, Scott [R-PA-10] · R · Cosponsor
- Rep. Ruiz, Raul [D-CA-25] · D · Cosponsor
- Rep. Dingell, Debbie [D-MI-6] · D · Cosponsor
- Rep. Eshoo, Anna G. [D-CA-18] · D · Cosponsor
- Rep. Matsui, Doris O. [D-CA-7] · D · Cosponsor
- Rep. Craig, Angie [D-MN-2] · D · Cosponsor
- Rep. Tonko, Paul [D-NY-20] · D · Cosponsor
- Rep. Gohmert, Louie [R-TX-1] · R · Cosponsor
- Rep. Van Drew, Jefferson [R-NJ-2] · D · Cosponsor
- Rep. Clarke, Yvette D. [D-NY-9] · D · Cosponsor
- Rep. Courtney, Joe [D-CT-2] · D · Cosponsor
- Colin Allred · D · Cosponsor
- Rep. Schakowsky, Janice D. [D-IL-9] · D · Cosponsor
- Rep. Crow, Jason [D-CO-6] · D · Cosponsor
- Anthony Gonzalez · R · Cosponsor
- Rep. Larson, John B. [D-CT-1] · D · Cosponsor
- Rep. McAdams, Ben [D-UT-4] · D · Cosponsor
- Rep. Schrader, Kurt [D-OR-5] · D · Cosponsor
- Rep. Davis, Rodney [R-IL-13] · R · Cosponsor
- Rep. Pappas, Chris [D-NH-1] · D · Cosponsor
- Rep. Kennedy, Joseph P., III [D-MA-4] · D · Cosponsor
- Rep. Davids, Sharice [D-KS-3] · D · Cosponsor
- Rep. Norcross, Donald [D-NJ-1] · D · Cosponsor
- Rep. Spanberger, Abigail Davis [D-VA-7] · D · Cosponsor
- Rep. Quigley, Mike [D-IL-5] · D · Cosponsor
- Rep. Deutch, Theodore E. [D-FL-22] · D · Cosponsor
- Rep. Langevin, James R. [D-RI-2] · D · Cosponsor
- Rep. Cooper, Jim [D-TN-5] · D · Cosponsor
- Rep. McBath, Lucy [D-GA-6] · D · Cosponsor
- Rep. Raskin, Jamie [D-MD-8] · D · Cosponsor
- Rep. Mucarsel-Powell, Debbie [D-FL-26] · D · Cosponsor
- Rep. Stanton, Greg [D-AZ-4] · D · Cosponsor
- Rep. Jordan, Jim [R-OH-4] · R · Cosponsor
Showing 48 of 71 sponsors and actors.
Related records
- related to → Lower Costs, More Cures Act of 2019
- related to → CREATES Act of 2019
- related to ← Strengthening Health Care and Lowering Prescription Drug Costs Act
- related to ← Further Consolidated Appropriations Act, 2020
- related to ← Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act
- related to ← Lower Health Care Costs Act
- related to ← Competition Prescription Act of 2019
Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.congress.gov/bill/116th-congress/house-bill/965
- Open data entity: https://api.congress.gov/v3/bill/116/hr/965
- us · 116-hr-965 · source updated 5 December 2025