United States 118th Congress Status: Died Bipartisan · 16 D · 16 R cosponsors

HR 1092 — BENEFIT Act of 2023

Last action — Referred to the Subcommittee on Health.

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  1. ✓
    Introduced
  2. ✓
    In Committee
  3. Died in session

This bill died with 118th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.

Summary

To strengthen the use of patient-experience data within the benefit-risk framework for approval of new drugs.

Bill Text

Sections of law this bill changes

1 section in 1 law

From the bill's own amending language, matched to the official United States Code (current through Public Law 119-124).

Federal food, drug, and cosmetic act · 21 U.S.C. ch. 9 1 section
  • § 360bbb-8c Patient participation in medical product discussion Amends

    21 U.S.C. § 360bbb-8c

    The law today

    (a) Patient engagement in drugs and devices (1) In general The Secretary shall develop and implement strategies to solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussions, including by— (A) fostering participation of a patient representative who may serve as a special government employee in appropriate agency meetings with medical product sponsors and investigators; and (B) exploring means to provide for identification of patient representatives who do not have any, or have minimal, financial interests in the medical products industry. (2) Protection of proprietary information Nothing in this section shall be construed to alter the protections offered by laws, regulations, or policies governing disclosure of confidential commercial or trade secret information and any other information exempt from disclosure pursuant to section 552(b) of title 5 as such laws, regulations, or policies would apply to consultation with individuals and organizations prior to July 9, 2012. (3) Other consultation Nothing in this section shall be construed to limit the ability of the Secretary to consult with individuals and organizations as authorized prior to July 9, 2012. (4) No right or obligation Nothing in this section shall be construed to create a legal right for a consultation on any matter or require the Secretary to meet with any particular expert or stakeholder. Nothing in this section shall be construed to alter agreed upon goals and procedures identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012. Nothing in this section is intended to increase the number of review cycles as in effect before July 9, 2012. (5) Financial interest In this section, the term “financial interest” means a financial interest under section 208(a) of title 18. (b) Statement of patient experience (1) In general Following the approval of an application that was submitted under section 355(b) of this title or section 262(a) of title 42 at least 180 days after December 13, 2016, the Secretary shall make public a brief statement regarding the patient experience data and related information, if any, submitted and reviewed as part of such application. (2) Data and information The data and information referred to in paragraph (1) are— (A) patient experience data; (B) information on patient-focused drug development tools; and (C) other relevant information, as determined by the Secretary. (c) Patient experience data For purposes of this section, the term “patient experience data” includes data that— (1) are collected by any persons (including patients, family members and caregivers of patients, patient advocacy organizations, disease research foundations, researchers, and drug manufacturers); and (2) are intended to provide information about patients’ experiences with a disease or condition, including— (A) the impact (including physical and psychosocial impacts) of such disease or condition, or a related therapy or clinical investigation on patients’ lives; and (B) patient preferences with respect to treatment of such disease or condition.

    14 other bills also change this section · Follow it → Official text at uscode.house.gov ↗

How this bill changes current law

4 changes Share ↗

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill amends the Federal Food, Drug, and Cosmetic Act to include patient-experience data in the risk-benefit assessment framework for new drug approvals.

  • 21 U.S.C. 360bbb-8c

    ; and → ;

    Changes the punctuation in the first subparagraph of subsection (a)(1) to facilitate the addition of a new subparagraph.

  • 21 U.S.C. 360bbb-8c

    . → ; and

    Changes the punctuation in the second subparagraph of subsection (a)(1) to facilitate the addition of a new subparagraph.

  • 21 U.S.C. 360bbb-8c

    (C) as part of the risk-benefit assessment framework in the new drug approval process described in section 505(d), considering patient experience data submitted by the medical product sponsor or another party.

    Adds a new subparagraph mandating the consideration of patient experience data in the risk-benefit assessment for drug approvals.

  • 21 U.S.C. 360bbb-8c

    , including a description of how such data and information were considered in the risk-benefit assessment described in section 505(d)

    Expands the requirement in subsection (b)(1) to include a description of the consideration of patient experience data in risk-benefit assessments.

Action History

  1. Referred to the Subcommittee on Health.

  2. Introduced in House

  3. Introduced in House

  4. Referred to the House Committee on Energy and Commerce.

Sponsors

Sponsorship breakdown

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1 sponsors · 31 co-sponsors · 515 not signed on

Sponsors (1)

Co-sponsors (31)

Not signed on (515)

515 members have not signed on to this bill.

Show all 515 →

"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

Whip count is in markup. Polling the chamber and every recorded vote this session. Only the first open is slow. It’s instant for you after this. Calling the roll · Tallying · Engrossing

Subjects

healthcare health-insurance
Cross-referencing the record. Reading this bill against every other bill in the corpus by meaning, not keywords. Only the first open is slow. It’s instant for you after this. Matching · Ranking · Engrossing

Frequently asked questions

What does HR 1092 do?
To strengthen the use of patient-experience data within the benefit-risk framework for approval of new drugs.
Who sponsors HR 1092?
HR 1092 is sponsored by Matsui, Doris O. (Democratic), Wenstrup, Brad R. (Republican), Bilirakis, Gus M. (Republican), Pingree, Chellie (Democratic), Yakym, Rudy (Republican), Green, Mark E. (Republican), Ross, Deborah K. (Democratic), Burchett, Tim (Republican), Golden, Jared F. (Democratic), Wild, Susan (Democratic), Bacon, Don (Republican), Cleaver, Emanuel (Democratic), Cárdenas, Tony (Democratic), Harder, Josh (Democratic), Fitzpatrick, Brian K. (Republican), Thanedar, Shri (Democratic), Higgins, Brian (Democratic), Norton, Eleanor Holmes (Democratic), Phillips, Dean (Democratic), Cole, Tom (Republican), Gottheimer, Josh (Democratic), Van Drew, Jefferson (Republican), González-Colón, Jenniffer (Republican), LaMalfa, Doug (Republican), Lawler, Michael (Republican), Thompson, Glenn (Republican), James, John (Republican), Wasserman Schultz, Debbie (Democratic), Tonko, Paul (Democratic), Landsman, Greg (Democratic), Balderson, Troy (Republican), and Grothman, Glenn (Republican).
What is the current status of HR 1092?
This bill died with 118th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track HR 1092?
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