United States 119th Congress Status: In Committee Bipartisan · 1 D · 1 R cosponsors

HR 5158 — Fair Price Device Act

Last action — Referred to the House Committee on Energy and Commerce.

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  1. ✓
    Introduced
  2. 2
    In Committee
  3. 3
    Passed House
  4. 4
    Passed Senate
  5. 5
    To Executive
  6. 6
    Enacted

This bill is in committee in the House. Introduced September 04, 2025. It must pass committee before a floor vote.

Next likely step: a committee vote, then a floor vote in the House.

Prognosis

Advancing 34% · moderate confidence

Where this bill stands today.

Odds of enactment

Low

How often bills like it became law.

  • In Committee

    Current position in the legislative process.

  • 2 sponsors

    1 primary, 1 co-sponsors signed on.

  • Bipartisan support

    Sponsored across 2 parties (1 D · 1 R) — cross-party backing.

Prognosis reads this bill's own signals — stage, sponsorship breadth, committee status, recorded votes and cross-state momentum. Odds come from a model trained on which bills have become law.

Bill Text

How this bill changes current law

10 changes Share ↗

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

The bill amends the approval process for generic drugs intended for use with devices by adding additional information requirements and clarifications.

  • 21 U.S.C. 355(j)(2)(A)

    except for changes required because of differences → except for changes required or appropriate, as determined by the Secretary, because of differences

    This change broadens the scope of changes allowed by indicating they must be appropriate as determined by the Secretary.

  • 21 U.S.C. 355(j)(2)(A)(v)

    , including changes as a result of differences that are otherwise permitted under this subsection, such as changes as a result of appropriate differences in the device for use with the new drug

    This addition allows for changes resulting from differences in the device used with the new drug.

  • 21 U.S.C. 355(j)(2)(A)(vii)

    and

    This change updates the punctuation to properly connect clauses.

  • 21 U.S.C. 355(j)(2)(A)(viii)

    . → ; and

    This change updates the punctuation to prepare for the addition of another clause.

  • 21 U.S.C. 355(j)(2)(A)

    (ix) if the listed drug referred to in clause (i) is intended for use with a device, relevant information as determined by the Secretary to support that the new drug for use with the device can be expected to have the same clinical effect and safety profile as the listed drug for use with the device when administered to patients under the conditions specified in the labeling of the drug, which information-- (I) shall be in addition to information under clauses (i) through (viii) that is relevant, as determined by the Secretary, to the evaluation of the new drug for use with the device and the device proposed for use with the new drug; and (II) may include-- (aa) information (comparative and non-comparative) regarding the device and its performance, including information about the compatibility of the new drug with the device and information regarding the delivery of the new drug when used with the device; (bb) comparative analyses of the new drug for use with the device and the listed drug for use with its device, including information identifying any differences between the user interface of the new drug and listed drug; information identifying any differences between the user interface of the device proposed for use with the new drug and the device used with the listed drug; and information to show that, despite any such differences, the new drug when used with the device can be expected to have the same clinical effect and safety profile as the listed drug when used with the device when administered to patients under the conditions specified in the labeling of the drug; and (cc) comparative and non-comparative human factors studies.

    This new clause establishes requirements for information needed to demonstrate that a new drug for use with a device can be expected to match the clinical effect and safety profile of a listed drug used with the respective device.

  • 21 U.S.C. 355(j)(2)(A)

    through (viii) → through (ix)

    This change updates the reference to include the newly inserted clause.

  • 21 U.S.C. 355(j)(4)

    except for changes required because of differences → except for changes required or appropriate, as determined by the Secretary, because of differences

    This change mirrors a previous amendment, allowing broader discretionary changes related to differences.

  • 21 U.S.C. 355(j)(4)(G)

    , including changes as a result of differences that are otherwise permitted under this subsection, such as changes as a result of appropriate differences in the device for use with the new drug

    This addition allows for similar changes concerning devices used with new drugs.

  • 21 U.S.C. 355(j)(4)

    subparagraphs (J) through (K) → subparagraphs (K) through (L)

    This change updates the numbering of subparagraphs to reflect prior amendments.

  • 21 U.S.C. 355(j)(4)(I)

    (J) if the listed drug is intended for use with a device, information submitted in the application is insufficient to show that the new drug for use with the device can be expected to have the same clinical effect and safety profile as the listed drug for use with the device when administered to patients under the conditions specified in the labeling of the drug;

    This addition specifies the need for information regarding clinical effect and safety profile when the listed drug is intended for use with a device.

Action History

  1. Introduced in House

  2. Introduced in House

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

Sponsors

Sponsorship breakdown

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1 sponsors · 1 co-sponsors · 545 not signed on

Sponsors (1)

Co-sponsors (1)

Not signed on (545)

545 members have not signed on to this bill.

Show all 545 →

"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

public-safety veterans healthcare health-insurance
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Frequently asked questions

Who sponsors HR 5158?
HR 5158 is sponsored by Scholten, Hillary J. (Democratic) and Maloy, Celeste (Republican).
What is the current status of HR 5158?
This bill is in committee in the House. Introduced September 04, 2025. It must pass committee before a floor vote.
Where can I track HR 5158?
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Last checked for changes 4 months ago · updated continuously

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