3.0.0 6260 2022-08-10T23:26:47Z 2022-08-10T23:26:47Z House HR 2020-03-12 116 [Congressional Record Volume 166, Number 48 (Thursday, March 12, 2020)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. ROY:H.R. 6260.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8, Clause 18 of the United StatesConstitution--to make all Laws which shall be necessary andproper for carrying into Execution the foregoing Powers, andall other Powers vested by this Constitution in theGovernment of the United States, or any Department or Officerthereof.[Page H1671]]]> hsru00 Rules Committee House Standing Referred to 2020-03-12T13:06:05Z hsif00 Energy and Commerce Committee House Standing Referred to 2020-03-12T13:06:00Z Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2020 116 6258 HR 2020-03-12 Referred to the House Committee on Energy and Commerce. Related bill CRS Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Co­ro­na­vi­rus Patients Act of 2020 116 3545 S 2020-03-19 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Identical bill CRS Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 116 2161 S 2019-07-18 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS RECOVERY Act 116 4537 S 2020-09-08 Read twice and referred to the Committee on Finance. Related bill CRS 2020-03-12 Referred to the Committee on Energy and Commerce, and in addition to the Committee on Rules, 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 hsru00 Rules Committee 2020-03-12 Referred to the Committee on Energy and Commerce, and in addition to the Committee on Rules, 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 2020-03-12 Introduced in House IntroReferral Intro-H 9 Library of Congress 2020-03-12 Introduced in House IntroReferral 1000 9 Library of Congress R000614 Rep. Roy, Chip [R-TX-21] Chip Roy R TX 21 N S001183 Rep. Schweikert, David [R-AZ-6] David Schweikert R AZ 6 2020-04-17 False Health Cardiovascular and respiratory health Congressional oversight Drug safety, medical device, and laboratory regulation Emergency medical services and trauma care Infectious and parasitic diseases Health 00 2020-03-12 Introduced in House 2020-04-02T17:34:00Z Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020

This bill establishes a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country for the treatment or prevention of COVID-19 (i.e., coronavirus disease 2019) and there is an unmet need relative to certain diseases.

Specifically, the bill requires the product's sponsor to demonstrate, among other things, that

  • the product has been approved for the treatment or prevention of COVID-19 or another disease of epidemic potential,
  • the approval is in one of the specified countries,
  • the FDA and listed countries have not withdrawn approval because of safety or effectiveness concerns, and
  • there is a public health or unmet medical need for the product.

The FDA may only decline approval if the FDA determines that the product is not safe or effective. The FDA must make such a determination not later than 30 days after receiving a request.

Congress may pass a joint resolution to grant reciprocal marketing approval of a product that the FDA declines to approve through the reciprocal process.

]]> Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 Display Title Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes. Introduced in House IH Short Title(s) as Introduced Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 Introduced in House IH Introduced in House 2020-03-12T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr6260ih/xml/BILLS-116hr6260ih.xml 2020-03-12 Referred to the Committee on Energy and Commerce, and in addition to the Committee on Rules, 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. 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.