S 340 116th Congress Senate Health Civil actions and liability Drug safety, medical device, and laboratory regulation Licensing and registrations Prescription drugs Product development and innovation

CREATES Act of 2019

Introduced: February 5, 2019 See on congress.gov

Everywhere this bill has been 3 steps

Introduced

In committee

Reported out

Passed House

Passed Senate

To President

Became law

Feb 6, 2019

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

Feb 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)

Feb 5, 2019

Introduced in Senate

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Plain-English summary Congressional Research Service

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.

What's happening now February 6, 2019

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

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