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Bill > S340
US S340
US S340CREATES Act of 2019 Creating and Restoring Equal Access to Equivalent Samples Act of 2019
summary
Introduced
02/05/2019
02/05/2019
In Committee
Crossed Over
Passed
Dead
12/31/2020
12/31/2020
Introduced Session
116th Congress
Bill Summary
A BILL To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. 1
AI Summary
This bill, the Creating and Restoring Equal Access to Equivalent Samples Act of 2019 or the CREATES Act of 2019, aims to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those products. The key provisions include: allowing eligible generic product developers to obtain sufficient quantities of a covered product (a drug or biological product) on commercially reasonable, market-based terms; providing an expedited process for eligible generic product developers to obtain authorization from the Secretary of Health and Human Services to obtain samples of covered products subject to a risk evaluation and mitigation strategy (REMS); and clarifying the REMS approval process for subsequent generic filers. The bill also includes provisions to limit liability for license holders and to ensure the provision of samples does not violate REMS requirements.
Sponsors (42)
Patrick Leahy (D)*,
Tammy Baldwin (D),
Richard Blumenthal (D),
Cory Booker (D),
Mike Braun (R),
Sherrod Brown (D),
Shelley Moore Capito (R),
Tom Carper (D),
Susan Collins (R),
Tom Cotton (R),
Kevin Cramer (R),
Ted Cruz (R),
Steve Daines (R),
Dick Durbin (D),
Joni Ernst (R),
Dianne Feinstein (D),
Deb Fischer (R),
Kirsten Gillibrand (D),
Chuck Grassley (R),
Maggie Hassan (D),
Mazie Hirono (D),
John Hoeven (R),
John Neely Kennedy (R),
Angus King (I),
Amy Klobuchar (D),
Mike Lee (R),
Ed Markey (D),
Martha McSally (R),
Bob Menendez (D),
Lisa Murkowski (R),
Rand Paul (R),
Gary Peters (D),
Jack Reed (D),
Jacky Rosen (D),
Mike Rounds (R),
Jeanne Shaheen (D),
Tina Smith (D),
Debbie Stabenow (D),
Jon Tester (D),
Chris Van Hollen (D),
Sheldon Whitehouse (D),
Todd Young (R),
Last Action
Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 22. (on 02/06/2019)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://www.congress.gov/bill/116th-congress/senate-bill/340/all-info |
| BillText | https://www.congress.gov/116/bills/s340/BILLS-116s340pcs.pdf |
| Bill | https://www.congress.gov/116/bills/s340/BILLS-116s340pcs.pdf.pdf |
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