3.0.0 5402 2022-10-28T01:45:59Z 2022-10-28T01:45:59Z House HR 2019-12-11 116 [Congressional Record Volume 165, Number 198 (Wednesday, December 11, 2019)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. GOTTHEIMER:H.R. 5402.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 18: To make all laws thatshall be necessary and proper for carrying into execution theforegoing powers, and all powers vested by this Constitutionin the government of the United States, or in any departmentor officer thereof.[Page H10124]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2019-12-12T17:40:27Z Referred to 2019-12-11T15:01:10Z hswm00 Ways and Means Committee House Standing Referred to 2019-12-11T15:01:05Z 2019-12-12 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2019-12-11 Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, 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. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2019-12-11 Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, 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. IntroReferral H11100 2 House floor actions hswm00 Ways and Means Committee 2019-12-11 Introduced in House IntroReferral Intro-H 9 Library of Congress 2019-12-11 Introduced in House IntroReferral 1000 9 Library of Congress G000583 Rep. Gottheimer, Josh [D-NJ-5] Josh Gottheimer D NJ 5 N U000031 Rep. Upton, Fred [R-MI-6] FRED UPTON R MI 6 2019-12-11 True F000466 Rep. Fitzpatrick, Brian K. [R-PA-1] Brian Fitzpatrick R PA K. 1 2019-12-18 False Taxation Drug safety, medical device, and laboratory regulation Drug therapy Government studies and investigations Income tax credits Medical research Taxation 00 2019-12-11 Introduced in House 2020-01-07T16:52:19Z Protecting America's Life Saving Medicines Act of 2019

This bill directs the Food and Drug Administration (FDA) to conduct a study on drugs that are currently being tested and are unlikely to be approved, but would, if approved, address an unmet medical need for the treatment of a serious or life threatening disease or condition or a rare disease or condition (high-risk, high-reward drugs). The FDA must submit to the Department of the Treasury a list of such high-risk, high-reward drugs not later than 180 days after the completion of the study.

The bill also allows a new tax credit for 25% of the clinical testing expenses for high-risk, high-reward drugs.

]]> Protecting America’s Life Saving Medicines Act of 2019 Display Title Protecting America’s Life Saving Medicines Act of 2019 Official Title as Introduced To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to conduct a study on high-risk, high-reward drugs, and for other purposes. Introduced in House IH Short Title(s) as Introduced Protecting America’s Life Saving Medicines Act of 2019 Introduced in House IH Introduced in House 2019-12-11T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr5402ih/xml/BILLS-116hr5402ih.xml 2019-12-12 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.