HR 4472 · 117th Congress 2021–2023, ended

BENEFIT Act of 2021

Latest action · Jul 19, 2021 Referred to the Subcommittee on Health.

Progress

Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.

  1. IntroducedJul 16, 2021
  2. Passed HouseNot reached
  3. Passed SenateNot reached
  4. To the PresidentNot reached
  5. Became lawNot reached

Summary

Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2021 or the BENEFIT Act of 2021

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.

Cosponsors 17

Members who signed on, in the order they did. Signatures ran from Jul 16, 2021 to May 27, 2022; 1 is an original cosponsor, there from the day it was introduced.

SeatCosponsorSigned on
R-OHBrad R. WenstrupOriginalJul 16, 2021
R-PABrian K. FitzpatrickJul 21, 2021
R-CADoug LaMalfaAug 13, 2021
D-CATony CárdenasNov 4, 2021
R-NEDon BaconJan 20, 2022
D-GASanford D. Bishop, Jr.Mar 2, 2022
D-PASusan WildMar 8, 2022
D-FLDarren SotoMar 9, 2022
D-NYBrian HigginsMar 11, 2022
R-NEJeff FortenberryMar 11, 2022
D-DCEleanor Holmes NortonMar 15, 2022
D-MOEmanuel CleaverMar 15, 2022
R-OKTom ColeMar 16, 2022
R-SCRalph NormanMar 17, 2022
R-PRJenniffer González-ColónApr 18, 2022
R-CAYoung KimApr 27, 2022
D-CAMark DeSaulnierMay 27, 2022

Committees 1

Where it was sent and what each committee and subcommittee did with it, in order.

ChamberCommitteeWhat it did
HouseEnergy and Commerce Committee
Referred Jul 16, 2021
Health Subcommittee
Referred Jul 19, 2021

Actions 3

Everything that happened, newest first.

  1. Jul 19, 2021Referred to the Subcommittee on Health.
  2. Jul 16, 2021Introduced in House
  3. Jul 16, 2021Referred to the House Committee on Energy and Commerce.

Research

What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.

Constitutional authority

Congress has the power to enact this legislation pursuant to the following: Article 1, Section 8, Clause 1 of the U.S. Constitution

The sponsor’s statement, as printed in the Congressional Record, vol. 167, no. 125, July 16, 2021, page H3633.

Printed hearings 1

Hearings whose printed record names this bill, newest first: hearings on it, and wider hearings where it came up.

NumberHearingCommitteeHeld
Serial No. 117-75THE FUTURE OF MEDICINE: LEGISLATION TO ENCOURAGE INNOVATION AND IMPROVE OVERSIGHT308 pagesEnergy and Commerce CommitteeMar 17, 2022

Related bills 1

Companion bills and other measures the record links to this one.

BillTitleRelationshipLatest action
S 373BENEFIT Act of 2021Identical billFeb 23, 2021

Titles 3

Every title it has carried, official and short, at each stage.

Official Title as Introduced
To strengthen the use of patient-experience data within the benefit-risk framework for approval of new drugs.
Short Title(s) as Introduced
BENEFIT Act of 2021
Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2021

Subjects

Assigned by the Library of Congress. Policy area: Health.

Text 1

Each version as it was printed, newest first.

  1. Jul 16, 2021Introduced in House

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Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.