3.0.0 5657 2023-01-11T13:25:31Z 2023-01-11T13:25:31Z House H HR 2014-09-18 113 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. STIVERS:H.R. 5657.Congress has the power to enact this legislation pursuantto the following:=========================== NOTE ===========================September 18, 2014, on page H7892, the following appeared: By[Page H7892]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2014-09-19T20:32:46Z Referred to 2014-09-18T13:00:34Z 2014-09-19 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2014-09-18 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2014-09-18 Introduced in House IntroReferral Intro-H 9 Library of Congress 2014-09-18 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 2014-09-18 True Health Administrative remedies Competition and antitrust Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Intellectual property Licensing and registrations Medical research Prescription drugs Product development and innovation Retail and wholesale trades Health 00 2014-09-18 Introduced in House 2015-03-13T15:21:24Z Fair Access for Safe and Timely Generics Act of 2014 or the FAST Generics Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to prohibit the license holder of a Food and Drug Administration (FDA)-approved drug from restricting availability of the drug for testing by a product developer seeking to develop a drug, generic drug, or biosimilar, including restricting availability with any aspect of a risk evaluation and mitigation strategy (REMS).

Directs the Secretary to authorize product developers to obtain approved drugs for testing if the product developer is a license holder of an approved drug or the Secretary determines the product developer can comply with laws applicable to drug development.

Requires the Secretary to authorize a product developer to conduct human clinical trials with an approved drug if the product developer's clinical trial protocol includes protections comparable to the distribution restrictions on the approved drug.

Establishes a process for a product developer to obtain reasonable quantities of an approved drug when those quantities are not available commercially.

Allows the Secretary to prohibit or limit transfer of an approved drug to a product developer if the transfer poses an imminent hazard to public health.

Eliminates license holder liability for claims arising from a product developer's testing of an approved drug.

Requires the FDA and the Federal Trade Commission (FTC) to report on noncompliance with this Act.

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

]]> Fair Access for Safe and Timely Generics Act of 2014 Display Title Fair Access for Safe and Timely Generics Act of 2014 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 Fair Access for Safe and Timely Generics Act of 2014 Short Titles as Introduced FAST Generics Act of 2014 Introduced in House 2014-09-18T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr5657ih/xml/BILLS-113hr5657ih.xml 2014-09-19 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.