3.0.0 1376 2023-01-11T13:28:09Z 2023-01-11T13:28:09Z House HR 2015-03-16 114 [Congressional Record Volume 161, Number 44 (Monday, March 16, 2015)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. GRIFFITH:H.R. 1376.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 of the United StatesConstitution.[Page H1662]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2015-03-20T19:36:50Z Referred to 2015-03-16T16:01:25Z 2015-03-20 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2015-03-16 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2015-03-16 Introduced in House IntroReferral Intro-H 9 Library of Congress 2015-03-16 Introduced in House IntroReferral 1000 9 Library of Congress G000568 Rep. Griffith, H. Morgan [R-VA-9] H. Griffith R VA Morgan 9 N M001157 Rep. McCaul, Michael T. [R-TX-10] Michael McCaul R TX T. 10 2015-03-16 True P000608 Rep. Peters, Scott H. [D-CA-52] Scott Peters D CA H. 52 2015-03-16 True Health Administrative law and regulatory procedures Consumer affairs Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Health information and medical records Marketing and advertising Health 00 2015-03-16 Introduced in House 2015-08-12T20:59:03Z Patient Choice Act of 2015

Amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast track products determined by the Department of Health and Human Services (HHS) to be adequately safe. Treats provisional approval in the same manner as approval of a drug, except that provisional approval is subject to requirements related to informed consent and continued pursuit of safety and efficacy data for purposes of gaining approval for the drug.

Defines the term “adequately safe” to mean that: (1) for at least one population, the risk of death or morbidity of the drug is unlikely to be greater than the combined risks of death or morbidity of the disease and existing therapies; or (2) the drug has had a valid marketing authorization for at least four years in one of the countries specified and data adequate for the approval of that marketing authorization has been submitted to HHS.

Prohibits HHS from imposing any requirements for safety studies or data in addition to, or different than, the requirements for studies to establish safety for purposes of Phase 1 (initial introduction of an investigational new drug into humans) or Phase 2 (controlled clinical studies to evaluate the effectiveness of the drug for a particular indication in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug).

Applies the provisional approval only to the indication for which the drug was: (1) designated as a fast track product, and (2) demonstrated to be adequately safe.

Prescribes requirements for termination of provisional approval, withdrawal of provisional approval, and application of market exclusivity to fast-track approval products.

]]> Patient Choice Act of 2015 Display Title Patient Choice Act of 2015 Official Title as Introduced To amend chapter V of the Federal Food, Drug, and Cosmetic Act to permit provisional approval of fast track products. Introduced in House IH Short Titles as Introduced Patient Choice Act of 2015 Introduced in House 2015-03-16T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr1376ih/xml/BILLS-114hr1376ih.xml 2015-03-20 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.