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S. 340

Introduced

CREATES Act of 2019

Introduced 2/5/2019•116th Congress•Senate

Latest Action

Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 22.

2/6/2019 • Senate

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.

Introduced in Senate • 2/5/2019

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Topics & Subjects

Policy Area: Health
Civil actions and liabilityDrug safety, medical device, and laboratory regulationLicensing and registrationsPrescription drugsProduct development and innovation

Congressional Votes (0)

No recorded votes yet

Roll call votes will appear here as the bill moves through Congress

Related Federal Spending

Sponsor & Cosponsors (42)

Party Breakdown

23
Democrats
18
Republicans
1
Independents

Sponsor

S[
Sen. Leahy, Patrick J. [D-VT]

Democrat • VT

Sponsored 2/5/2019

Cosponsors (41)

S[
Sen. Grassley, Chuck [R-IA]

R-IA

Joined 2/5/2019

S[
Sen. Klobuchar, Amy [D-MN]

D-MN

Joined 2/5/2019

S[
Sen. Lee, Mike [R-UT]

R-UT

Joined 2/5/2019

S[
S[
Sen. Baldwin, Tammy [D-WI]

D-WI

Joined 2/5/2019

S[

Bill Journey

Originated in the Senate

Introduced

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)

Committee Review

Floor Debate

Passed Chamber

Other Chamber

President

Enacted into Law

Text Versions (1)

Placed on Calendar Senate2/6/2019

Details

Bill TypeS
Current StatusIntroduced
Cosponsors41