To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products.
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.Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Became Public Law No: 116-94.
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 133.
Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 22.
Referred to the Subcommittee on the Constitution, Civil Rights, and Civil Liberties.
Introduced in House
Introduced in House
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.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Subcommittee Consideration and Mark-up Session Held.
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Committee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended) by the Yeas and Nays: 50 - 0.
Committee Consideration and Mark-up Session Held.
checking server…
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line
Ordered to be Reported by Voice Vote.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-55, Part I.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-55, Part I.
Reported by the Committee on Judiciary. H. Rept. 116-55, Part II.
Reported by the Committee on Judiciary. H. Rept. 116-55, Part II.
Placed on the Union Calendar, Calendar No. 33.
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.
Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.
Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.