3.0.0 3056 2023-01-11T13:32:39Z 2023-01-11T13:32:39Z Senate S 2016-06-14 114 ssju00 Judiciary Committee Senate Standing ssju01 Competition Policy, Antitrust, and Consumer Rights Subcommittee Hearings by 2016-06-21T18:08:34Z Referred to 2016-06-14T20:53:09Z 2016-06-21 ssju01 Competition Policy, Antitrust, and Consumer Rights Subcommittee Senate Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights. Hearings held. Committee 2016-06-14 ssju00 Judiciary Committee Senate Read twice and referred to the Committee on the Judiciary. (Sponsor introductory remarks on measure: CR S3862-3863) IntroReferral 2016-06-14 Introduced in Senate IntroReferral 10000 9 Library of Congress L000174 Sen. Leahy, Patrick J. [D-VT] Patrick Leahy D VT N G000386 Sen. Grassley, Chuck [R-IA] Charles Grassley R IA E. 2016-06-14 True K000367 Sen. Klobuchar, Amy [D-MN] Amy Klobuchar D MN 2016-06-14 True L000577 Sen. Lee, Mike [R-UT] Mike Lee R UT 2016-06-14 True C001035 Sen. Collins, Susan M. [R-ME] Susan Collins R ME M. 2016-06-21 False M001170 Sen. McCaskill, Claire [D-MO] Claire McCaskill D MO 2016-06-21 False B001277 Sen. Blumenthal, Richard [D-CT] Richard Blumenthal D CT 2016-07-14 False M000303 Sen. McCain, John [R-AZ] JOHN MCCAIN R AZ SIDNEY 2016-07-14 False W000802 Sen. Whitehouse, Sheldon [D-RI] Sheldon Whitehouse D RI 2016-09-13 False V000127 Sen. Vitter, David [R-LA] David Vitter R LA 2016-09-13 False D000563 Sen. Durbin, Richard J. [D-IL] Richard Durbin D IL J. 2016-09-22 False C001095 Sen. Cotton, Tom [R-AR] Tom Cotton R AR 2016-09-22 False Health Civil actions and liability Drug safety, medical device, and laboratory regulation Licensing and registrations Prescription drugs Product development and innovation Health 00 2016-06-14 Introduced in Senate 2017-04-19T19:49:44Z Creating and Restoring Equal Access to Equivalent Samples Act of 2016 or the CREATES Act of 2016

This bill permits the developer of a drug or biological product to bring a civil action against the license holder of an approved medication alleging that the license holder: (1) declined to make available sufficient quantities of the approved medication for the developer's testing; or (2) failed to agree on, or refused to allow the developer to join, a single, shared system of elements to assure safe use (ETASU) of the medication. (Under current law, a generic version of a medication with ETASU must join the brand name medication's system of ETASU unless the developer of the generic has a waiver from the Food and Drug Administration.) The bill does not apply to medications for which there is a shortage, unless the shortage will not be promptly resolved.

In a civil action regarding the availability of sufficient quantities of a medication, it is an affirmative defense that the license holder: (1) is not manufacturing or marketing the medication and does not have access to a supply of the medication to make available, or (2) sells the medication without restrictions through other entities and the developer can purchase sufficient quantities of the medication from those entities.

]]> CREATES Act of 2016 Display Title CREATES Act of 2016 Official Title as Introduced A bill to provide for certain causes of action relating to delays of generic drugs and biosimilar biological products. Introduced in Senate IS Short Titles as Introduced CREATES Act of 2016 Short Titles as Introduced Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Introduced in Senate 2016-06-14T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s3056is/xml/BILLS-114s3056is.xml 2016-06-21 Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights. Hearings held. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.