CREATES Act of 2019

Bill: 116-hr-965
Sponsor: Rep. Cicilline, David N. [D-RI-1]
Introduced: 2019-02-05 in the House
Policy area: Health
Subjects: Civil actions and liability
Drug safety, medical device, and laboratory regulation
Licensing and registrations
Prescription drugs
Product development and innovation

Summary:
action_date: 2019-02-05
text: 

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: 2019-05-10
text: 

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: 2019-05-10
text: 

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.

Legislative actions:
action_date: 2019-05-16
text: Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.
action_date: 2019-05-16
text: Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.
action_date: 2019-05-16
text: 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.
action_date: 2019-05-10
text: Placed on the Union Calendar, Calendar No. 33.
action_date: 2019-05-10
text: Reported by the Committee on Judiciary. H. Rept. 116-55, Part II.
action_date: 2019-05-10
text: Reported by the Committee on Judiciary. H. Rept. 116-55, Part II.
action_date: 2019-05-10
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-55, Part I.
action_date: 2019-05-10
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-55, Part I.
action_date: 2019-04-30
text: Ordered to be Reported by Voice Vote.
action_date: 2019-04-30
text: Committee Consideration and Mark-up Session Held.
action_date: 2019-04-03
text: Ordered to be Reported (Amended) by the Yeas and Nays: 50 - 0.
action_date: 2019-04-03
text: Committee Consideration and Mark-up Session Held.
action_date: 2019-03-27
text: Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
action_date: 2019-03-27
text: Subcommittee Consideration and Mark-up Session Held.
action_date: 2019-03-22
text: Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
action_date: 2019-02-06
text: Referred to the Subcommittee on Health.
action_date: 2019-02-05
text: 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.
action_date: 2019-02-05
text: 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.
action_date: 2019-02-05
text: Introduced in House
action_date: 2019-02-05
text: Introduced in House