3.0.0 3385 2022-02-09T03:11:47Z 2022-02-09T09:20:26Z Senate S 2020-03-04 116 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2020-03-04T15:41:19Z 2020-03-04 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2020-03-04 Introduced in Senate IntroReferral 10000 9 Library of Congress W000437 Sen. Wicker, Roger F. [R-MS] Roger Wicker R MS F. N K000367 Sen. Klobuchar, Amy [D-MN] Amy Klobuchar D MN 2020-03-04 True Health Drug safety, medical device, and laboratory regulation Health information and medical records Product development and innovation Health 00 2020-03-04 Introduced in Senate 2021-05-14T18:42:08Z Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2020 or the BENEFIT Act of 2020

This bill requires the Food and Drug Administration (FDA) to consider relevant patient-focused drug development data, such as data from patient preference studies and patient-reported outcome data, in the risk-benefit assessment framework used in the process for approving new drugs.

After a new drug application has been approved, the FDA's public statement about how it used patient experience data shall include a description of how such data was considered in the risk-benefit assessment framework.

]]> BENEFIT Act of 2020 Display Title BENEFIT Act of 2020 Short Title(s) as Introduced BENEFIT Act of 2020 Introduced in Senate IS Short Title(s) as Introduced Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2020 Introduced in Senate IS Official Title as Introduced A bill to strengthen the use of patient-experience data within the benefit-risk framework for approval of new drugs. Introduced in Senate IS Introduced in Senate 2020-03-04T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s3385is/xml/BILLS-116s3385is.xml 2020-03-04 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.