3.0.0 2841 2023-01-11T13:30:52Z 2023-01-11T13:30:52Z House HR 2015-06-18 114 [Congressional Record Volume 161, Number 98 (Thursday, June 18, 2015)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. STIVERS:H.R. 2841.Congress has the power to enact this legislation pursuantto the following:This bill is enacted pursuant to the power granted toCongress under Article I, section 8, Clause 3 of the UnitedStates Constitution. The Constitution's Commerce Clauseallows Congress to enact laws when reasonably related to theregulation of interstate commerce.[Page H4543]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2015-06-19T15:05:47Z Referred to 2015-06-18T13:03:45Z 2015-06-19 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2015-06-18 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2015-06-18 Introduced in House IntroReferral Intro-H 9 Library of Congress 2015-06-18 Introduced in House IntroReferral 1000 9 Library of Congress S001187 Rep. Stivers, Steve [R-OH-15] Steve Stivers R OH 15 N W000800 Rep. Welch, Peter [D-VT-At Large] Peter Welch D VT 0 2015-06-18 True M001180 Rep. McKinley, David B. [R-WV-1] David McKinley R WV B. 1 2015-06-18 True S001145 Rep. Schakowsky, Janice D. [D-IL-9] JANICE SCHAKOWSKY D IL D. 9 2015-06-18 True R000586 Rep. Renacci, James B. [R-OH-16] James Renacci R OH B. 16 2015-06-18 True T000462 Rep. Tiberi, Patrick J. [R-OH-12] PATRICK TIBERI R OH J. 12 2015-06-18 True D000197 Rep. DeGette, Diana [D-CO-1] DIANA DEGETTE D CO 1 2015-06-23 False F000449 Rep. Fortenberry, Jeff [R-NE-1] Jeff Fortenberry R NE 1 2015-11-04 False C001090 Rep. Cartwright, Matt [D-PA-17] Matt Cartwright D PA 17 2015-11-04 False K000009 Rep. Kaptur, Marcy [D-OH-9] MARCY KAPTUR D OH 9 2015-11-04 False Health Competition and antitrust Drug safety, medical device, and laboratory regulation Licensing and registrations Prescription drugs Health 00 2015-06-18 Introduced in House 2016-01-07T19:37:37Z Fair Access for Safe and Timely Generics Act of 2015 or the FAST Generics Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the license holder of a Food and Drug Administration (FDA)-approved drug or biological product from restricting availability of the medication for testing by a product developer seeking to develop a drug, generic drug, or biosimilar, including restricting availability with a risk evaluation and mitigation strategy (REMS).

Upon request, the license holder of a medication that is not subject to a REMS must provide a product developer with the medication for testing.

For a medication subject to a REMS, a product developer must have FDA authorization to obtain the medication before the license holder must provide it. The FDA may authorize a product developer to conduct testing and clinical trials with the medication.

A wholesaler or specialty distributor who receives a request from a product developer for a medication for testing may not disclose to the license holder the identity of the product developer.

The FDA may prohibit or limit transfer of a medication to a product developer if the transfer poses an imminent hazard to public health.

License holders are not liable for claims arising from a product developer testing the medication.

The FDA may waive the requirement that a drug use a single, shared system of elements to assure safe use with a comparable approved drug if the product developer is unable to finalize terms for a shared system with the license holder of the approved drug.

]]> FAST Generics Act of 2015 Display Title FAST Generics Act of 2015 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. Introduced in House IH Short Titles as Introduced FAST Generics Act of 2015 Short Titles as Introduced Fair Access for Safe and Timely Generics Act of 2015 Introduced in House 2015-06-18T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr2841ih/xml/BILLS-114hr2841ih.xml 2015-06-19 Referred to the Subcommittee on Health. 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.