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Main Subject: Health

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.

HR19-116, HR987-116, HR1865-116, HR2700-116, S1895-116, S340-116, HR3947-116,

House floor actions Actions

Committee
May. 16 2019	Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.
May. 10 2019	Reported by the Committee on Judiciary. H. Rept. 116-55, Part II. Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-55, Part I.

Floor
May. 16 2019	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.

Calendars
May. 10 2019	Placed on the Union Calendar, Calendar No. 33.

IntroReferral

Feb. 05
2019

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.
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.

Library of Congress Actions

Committee
May. 16 2019	Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.
May. 10 2019	Reported by the Committee on Judiciary. H. Rept. 116-55, Part II. Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-55, Part I.

IntroReferral
Feb. 05 2019	Introduced in House Introduced in House

House committee actions Actions

Committee
Apr. 30 2019	Ordered to be Reported by Voice Vote. Committee Consideration and Mark-up Session Held.
Apr. 03 2019	Ordered to be Reported (Amended) by the Yeas and Nays: 50 - 0. Committee Consideration and Mark-up Session Held.
Mar. 27 2019	Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote . Subcommittee Consideration and Mark-up Session Held.
Mar. 22 2019	Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Feb. 06 2019	Referred to the Subcommittee on Health.

House bill HR965-116

CREATES Act of 2019

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