H.R. 965 · 116th Congress
CREATES Act of 2019
- Stage
- Reported from committee
- Sponsor
- David Cicilline
- Introduced
- 2019-02-05
- Latest action
- 2019-05-16 · PERMISSION TO FILE SUPPLEMENTAL - Ms. Lofgren asked unanimous consent that Committee on the Judiciary be authorized to file a supplemental report on the bill, H.R. 965. Agreed to without objection.
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.