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
Plain-English 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.
What's happening now
Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 22.