CREATES Act of 2019
Latest action · May 16, 2019 Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedFeb 5, 2019
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
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.Cosponsors 68
Members who signed on, in the order they did. Signatures ran from Feb 5, 2019 to May 10, 2019; 5 are original cosponsors, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-WV | David B. McKinley | Original | Feb 5, 2019 |
| R-GA | Doug Collins | Original | Feb 5, 2019 |
| R-WI | F. James Sensenbrenner, Jr. | Original | Feb 5, 2019 |
| D-NY | Jerrold Nadler | Original | Feb 5, 2019 |
| D-VT | Peter Welch | Original | Feb 5, 2019 |
| R-NC | Mark Meadows | Feb 11, 2019 | |
| D-IA | Abby Finkenauer | Mar 4, 2019 | |
| D-IL | Daniel Lipinski | Mar 11, 2019 | |
| D-TX | Lloyd Doggett | Mar 11, 2019 | |
| R-WI | Mike Gallagher | Mar 11, 2019 | |
| R-OK | Tom Cole | Mar 11, 2019 | |
| D-MN | Betty McCollum | Mar 18, 2019 | |
| D-IL | Bobby L. Rush | Mar 18, 2019 | |
| D-MI | Debbie Dingell | Mar 26, 2019 | |
| D-NJ | Frank Pallone, Jr. | Mar 26, 2019 |
Committees 2
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| House | Energy and Commerce Committee | Referred Feb 5, 2019Markup Apr 3, 2019Reported May 10, 2019 |
| Health Subcommittee | Referred Feb 6, 2019Markup Mar 27, 2019Reported Mar 27, 2019 | |
| House | Judiciary Committee | Referred Feb 5, 2019Markup Apr 30, 2019Reported May 17, 2019 |
| Administrative State, Regulatory Reform, and Antitrust Subcommittee | Referred Mar 22, 2019 |
Actions 15
Everything that happened, newest first.
- May 16, 2019PERMISSION 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.
- May 16, 2019Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.
- May 10, 2019Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-55, Part I.
- May 10, 2019Reported by the Committee on Judiciary. H. Rept. 116-55, Part II.
- May 10, 2019Placed on the Union Calendar, Calendar No. 33.
- Apr 30, 2019Committee Consideration and Mark-up Session Held.
- Apr 30, 2019Ordered to be Reported by Voice Vote.
- Apr 3, 2019Committee Consideration and Mark-up Session Held.
- Apr 3, 2019Ordered to be Reported (Amended) by the Yeas and Nays: 50 - 0.
- Mar 27, 2019Subcommittee Consideration and Mark-up Session Held.
- Mar 27, 2019Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
- Mar 22, 2019Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
- Feb 6, 2019Referred to the Subcommittee on Health.
- Feb 5, 2019Introduced in House
- Feb 5, 2019Referred 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.
In the Congressional Record 3
Days the Record’s own index lists this bill, newest first, with the pages and the members it names. Pages starting H are the House, S the Senate, E Extensions of Remarks.
| Where | In the Record | Members | Date |
|---|---|---|---|
| House | Debate and remarks H3911 | Zoe Lofgren D-CA | May 16, 2019 |
| House | Debate and remarks H3455 | Sylvia R. Garcia D-TX | May 7, 2019 |
| House | Debate and remarks H3429 | Ben McAdams D-UT | May 2, 2019 |
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Congressional Budget Office cost estimates 2
- May 9, 2019H.R. 965, CREATES Act of 2019As ordered reported by the House Committee on the Judiciary on April 30, 2019
- Apr 30, 2019H.R. 965, CREATES Act of 2019As ordered reported by the House Committee on Energy and Commerce on April 3, 2019
Constitutional authority
The sponsor’s statement, as printed in the Congressional Record, vol. 165, no. 22, February 5, 2019, page H1362.
Printed hearings 10
Hearings whose printed record names this bill, newest first: hearings on it, and wider hearings where it came up.
| Number | Hearing | Committee | Held |
|---|---|---|---|
| Serial No. 116-108 | DEMOCRATIC BACKSLIDING IN SUB-SAHARAN AFRICA89 pages | Foreign Affairs Committee | Sep 30, 2020 |
| Serial No. 116-093 | MARKUP OF: H.R. 7903, "TO AMEND THE SMALL BUSINESS ACT TO ESTABLISH THE COMMUNITY ADVANTAGE LOAN PROGRAM" H.R. 8211, "504 MODERNIZATION AND SMALL MANUFACTURER ENHANCEMENT ACT OF 2020" H.R. 8199, "504 CREDIT RISK MANAGEMENT IMPROVEMENT ACT OF 2020" H.R. 8229, "PARITY FOR HUBZONE APPEALS ACT OF 2020"78 pages | Small Business Committee | Sep 16, 2020 |
| Serial No. 116-116 | THE HEALTH, ECONOMIC, AND POLITICAL CHALLENGES FACING LATIN AMERICA AND THE CARIBBEAN63 pages | Foreign Affairs Committee | Sep 15, 2020 |
| Serial No. 116-088 | OVERSIGHT OF THE SMALL BUSINESS ADMINISTRATION AND DEPARTMENT OF TREASURY PANDEMIC PROGRAMS74 pages | Small Business Committee | Jul 17, 2020 |
| Serial No. 116-086 | LONG-LASTING SOLUTIONS FOR A SMALL BUSINESS RECOVERY139 pages | Small Business Committee | Jul 15, 2020 |
CRS reports 3
Congressional Research Service work that CRS links to this bill or the law it became, newest first.
Cite it 3
Products on other subjects that cite it, usually among other measures.
| Product | Title | Kind | Published |
|---|---|---|---|
| R44832 | Frequently Asked Questions About Prescription Drug Pricing and Policy | Report | May 6, 2021 |
| R46741 | Drug Pricing and Intellectual Property: The Legislative Landscape for the 117th Congress | Report | Mar 31, 2021 |
| R44620 | Biologics and Biosimilars: Background and Key Issues | Report | Jun 6, 2019 |
Related bills 7
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 19 | Lower Costs, More Cures Act of 2019 | Related bill | Dec 19, 2019 |
| S 340 | CREATES Act of 2019 | Identical bill | Feb 6, 2019 |
| HR 987 | Strengthening Health Care and Lowering Prescription Drug Costs Act | Related bill | May 20, 2019 |
| HR 1865 | Further Consolidated Appropriations Act, 2020 | Related bill | Dec 20, 2019 |
| S 1895 | Lower Health Care Costs Act | Related bill | Jul 8, 2019 |
Titles 3
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- 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.
- Short Title(s) as Introduced
- CREATES Act of 2019
- Creating and Restoring Equal Access to Equivalent Samples Act of 2019
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 2
Each version as it was printed, newest first.
- May 10, 2019Reported in House
- Feb 5, 2019Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
