United States · Bill · S
S. 340 (116th)
CREATES Act of 2019
Introduced
5 February 2019
Last action
6 February 2019 · Calendars
Status
Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 22.
Sponsors
Sen. Leahy, Patrick J. [D-VT], Sen. Grassley, Chuck [R-IA], Sen. Klobuchar, Amy [D-MN], Sen. Lee, Mike [R-UT], Sen. Feinstein, Dianne [D-CA], Sen. Baldwin, Tammy [D-WI], Sen. Blumenthal, Richard [D-CT], Sen. Booker, Cory A. [D-NJ], Sen. Brown, Sherrod [D-OH], Sen. Collins, Susan M. [R-ME], Sen. Cotton, Tom [R-AR], Sen. Cruz, Ted [R-TX], Sen. Daines, Steve [R-MT], Sen. Durbin, Richard J. [D-IL], Sen. Ernst, Joni [R-IA], Sen. Fischer, Deb [R-NE], Sen. Hassan, Margaret Wood [D-NH], Sen. Kennedy, John [R-LA], Sen. King, Angus S., Jr. [I-ME], Sen. Menendez, Robert [D-NJ], Sen. Murkowski, Lisa [R-AK], Sen. Paul, Rand [R-KY], Sen. Rounds, Mike [R-SD], Sen. Smith, Tina [D-MN], Sen. Stabenow, Debbie [D-MI], Sen. Tester, Jon [D-MT], Sen. Whitehouse, Sheldon [D-RI], Sen. Young, Todd [R-IN], Sen. Braun, Mike [R-IN], Sen. Shaheen, Jeanne [D-NH], Sen. Cramer, Kevin [R-ND], Sen. Carper, Thomas R. [D-DE], Sen. Capito, Shelley Moore [R-WV], Sen. Van Hollen, Chris [D-MD], Sen. McSally, Martha [R-AZ], Sen. Hirono, Mazie K. [D-HI], Sen. Hoeven, John [R-ND], Sen. Gillibrand, Kirsten E. [D-NY], Sen. Peters, Gary C. [D-MI], Sen. Reed, Jack [D-RI], Sen. Rosen, Jacky [D-NV], Sen. Markey, Edward J. [D-MA]
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 the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time. (Sponsor introductory remarks on measure: CR S868-869)
Source: Calendars
5 February 2019
Introduced
Introduced in Senate
Source: IntroReferral
6 February 2019
Calendars
Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 22.
Source: Calendars
Votes
No vote records are attached yet.
Versions
- Placed on Calendar Senate · 6 February 2019 · Download file
Documents
3 official files
Placed on Calendar Senate (text)
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Placed on Calendar Senate (text)
Placed on Calendar Senate · EN · 6 February 2019
Placed on Calendar Senate (PDF)
Placed on Calendar Senate · EN · 6 February 2019
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Introduced in Senate
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
- Sen. Leahy, Patrick J. [D-VT] · D · Sponsor
- Sen. Grassley, Chuck [R-IA] · R · Sponsor
- Sen. Klobuchar, Amy [D-MN] · D · Sponsor
- Sen. Lee, Mike [R-UT] · R · Sponsor
- Sen. Feinstein, Dianne [D-CA] · D · Sponsor
- Sen. Baldwin, Tammy [D-WI] · D · Sponsor
- Sen. Blumenthal, Richard [D-CT] · D · Sponsor
- Sen. Booker, Cory A. [D-NJ] · D · Sponsor
- Sen. Brown, Sherrod [D-OH] · D · Sponsor
- Sen. Collins, Susan M. [R-ME] · R · Sponsor
- Sen. Cotton, Tom [R-AR] · R · Sponsor
- Sen. Cruz, Ted [R-TX] · R · Sponsor
- Sen. Daines, Steve [R-MT] · R · Sponsor
- Sen. Durbin, Richard J. [D-IL] · D · Sponsor
- Sen. Ernst, Joni [R-IA] · R · Sponsor
- Sen. Fischer, Deb [R-NE] · R · Sponsor
- Sen. Hassan, Margaret Wood [D-NH] · D · Sponsor
- Sen. Kennedy, John [R-LA] · R · Sponsor
- Sen. King, Angus S., Jr. [I-ME] · I · Sponsor
- Sen. Menendez, Robert [D-NJ] · D · Sponsor
- Sen. Murkowski, Lisa [R-AK] · R · Sponsor
- Sen. Paul, Rand [R-KY] · R · Sponsor
- Sen. Rounds, Mike [R-SD] · R · Sponsor
- Sen. Smith, Tina [D-MN] · D · Sponsor
- Sen. Stabenow, Debbie [D-MI] · D · Sponsor
- Sen. Tester, Jon [D-MT] · D · Sponsor
- Sen. Whitehouse, Sheldon [D-RI] · D · Sponsor
- Sen. Young, Todd [R-IN] · R · Sponsor
- Sen. Braun, Mike [R-IN] · R · Cosponsor
- Sen. Shaheen, Jeanne [D-NH] · D · Cosponsor
- Sen. Cramer, Kevin [R-ND] · R · Cosponsor
- Sen. Carper, Thomas R. [D-DE] · D · Cosponsor
- Sen. Capito, Shelley Moore [R-WV] · R · Cosponsor
- Sen. Van Hollen, Chris [D-MD] · D · Cosponsor
- Sen. McSally, Martha [R-AZ] · R · Cosponsor
- Sen. Hirono, Mazie K. [D-HI] · D · Cosponsor
- Sen. Hoeven, John [R-ND] · R · Cosponsor
- Sen. Gillibrand, Kirsten E. [D-NY] · D · Cosponsor
- Sen. Peters, Gary C. [D-MI] · D · Cosponsor
- Sen. Reed, Jack [D-RI] · D · Cosponsor
- Sen. Rosen, Jacky [D-NV] · D · Cosponsor
- Sen. Markey, Edward J. [D-MA] · D · Cosponsor
Related records
Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.congress.gov/bill/116th-congress/senate-bill/340
- Open data entity: https://api.congress.gov/v3/bill/116/s/340
- us · 116-s-340 · source updated 5 December 2025