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.
| Action Date | Type | Text | Source |
|---|---|---|---|
| 2019-05-16 | Committee | Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III. | House floor actions |
| 2019-05-16 | Floor | 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. | House floor actions |
| 2019-05-10 | Calendars | Placed on the Union Calendar, Calendar No. 33. | House floor actions |
| 2019-05-10 | Committee | Reported by the Committee on Judiciary. H. Rept. 116-55, Part II. | House floor actions |
| 2019-05-10 | Committee | Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-55, Part I. | House floor actions |
| 2019-04-30 | Committee | Ordered to be Reported by Voice Vote. | House committee actions |
| 2019-04-30 | Committee | Committee Consideration and Mark-up Session Held. | House committee actions |
| 2019-04-03 | Committee | Ordered to be Reported (Amended) by the Yeas and Nays: 50 - 0. | House committee actions |
| 2019-04-03 | Committee | Committee Consideration and Mark-up Session Held. | House committee actions |
| 2019-03-27 | Committee | Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote . | House committee actions |
| 2019-03-27 | Committee | Subcommittee Consideration and Mark-up Session Held. | House committee actions |
| 2019-03-22 | Committee | Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law. | House committee actions |
| 2019-02-06 | Committee | Referred to the Subcommittee on Health. | House committee actions |
| 2019-02-05 | IntroReferral | Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. | House floor actions |
| 2019-02-05 | IntroReferral | Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. | House floor actions |
| 2019-02-05 | IntroReferral | Introduced in House | Library of Congress |