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119-hr-5158119th CongressWALLET

Fair Price Device Act

Sponsored By: Representative Scholten, Hillary J. [D-MI-3]

Introduced

Summary

Raises the evidentiary bar for generic drugs paired with medical devices. This bill would require device-specific information and, where applicable, comparative and non-comparative human factors studies to show a generic drug used with a device can be expected to have the same clinical effect and safety profile as the listed drug when used under the drug's labeling.

Show full summary
  • Patients and caregivers: Aims to make drug-plus-device products safer and more predictable by asking for data that shows the combined product performs like the listed product.
  • Generic drug makers: Would need to submit device performance, compatibility, delivery information, and comparative analyses showing any user-interface differences do not change clinical effect or safety.
  • Device manufacturers and product developers: May need to provide data on device changes and user-interface differences when a device is paired with a new generic drug.
  • FDA (the Secretary): Gains authority to determine what device-specific information and studies are required or appropriate to establish equivalence.

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Bill Overview

Analyzed Economic Effects

1 provisions identified: 0 benefits, 0 costs, 1 mixed.

New rules for generic drug-device combinations

If enacted, makers of generic drugs used with devices would need extra proof. Proof could include device performance, compatibility, delivery, and human factors studies. Applicants would also compare user interfaces and show the same safety and effect as the listed product. The FDA could judge an application insufficient if that proof is missing. The FDA could require or allow device changes, and the rules would apply upon enactment.

Sponsors & CoSponsors

Sponsor

Scholten, Hillary J. [D-MI-3]

MI • D

Cosponsors

  • Rep. Maloy, Celeste [R-UT-2]

    UT • R

    Sponsored 9/15/2025

Roll Call Votes

No roll call votes available for this bill.

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