Fair Price Device Act
- Bill Number
- H.R. 5158
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-09-04: Referred to the House Committee on Energy and Commerce.
- Last Updated
- 2025-09-22T15:51:44Z
AI-Generated Summary
Purpose
The Fair Price Device Act (H.R. 5158) aims to update federal rules for approving generic versions of drugs that are designed to work with medical devices, such as inhalers or auto-injectors. By making it easier to show that these generics are safe and effective when used with compatible devices, the bill seeks to increase competition and potentially lower costs for patients.
Key Provisions
- Amendments to Abbreviated New Drug Applications (ANDAs): The bill modifies Section 505(j) of the Federal Food, Drug, and Cosmetic Act, which governs generic drug approvals.
- Allows the U.S. Food and Drug Administration (FDA, referred to as the "Secretary") to approve generics with differences in the accompanying device if those differences are deemed "required or appropriate" and do not affect safety or effectiveness.
- Adds a new requirement (clause (ix)) for applicants to submit evidence showing that the generic drug, when used with its proposed device, will have the same clinical effect (how well it works) and safety profile as the original (brand-name) drug with its device, under the conditions described in the drug's labeling.
- This evidence must supplement standard generic approval data and can include:
- Information on the device's performance and compatibility with the generic drug.
- Comparisons between the generic setup (drug + device) and the brand-name setup, explaining any differences in user interfaces (e.g., how the device is operated) and demonstrating they won't impact outcomes.
- Studies on human factors (how users interact with the device safely and effectively).
- Updates refusal criteria for ANDA approvals: The FDA can deny an application if the submitted information fails to prove the generic drug-device combination matches the brand-name version's clinical effect and safety.
Significant Changes to Existing Law
- Expanded Flexibility for Device Differences: Previously, generic approvals strictly limited changes due to device differences. The bill broadens this to include "appropriate" differences approved by the FDA, such as variations in the device itself, as long as they are justified under existing generic rules.
- New Evidence Requirements: Introduces specific data needs for drug-device combinations, which were not explicitly outlined before, ensuring generics address device-related factors like compatibility and user interaction.
- Additional Denial Ground: Adds a new reason for rejecting ANDAs related to insufficient proof of equivalence in drug-device performance, closing potential gaps in prior law.
Potential Impacts
- On Government Agencies: The FDA will need to review additional device-related data in generic applications, potentially increasing workload but providing clearer guidelines for evaluating combination products.
- On Citizens: Patients relying on drug-device products (e.g., for asthma or diabetes) could gain access to more affordable generic options faster, reducing healthcare costs. However, approval delays might occur if evidence requirements are not met.
- On International Relations: No direct impacts, as the bill focuses on domestic drug approval processes.
Main Stakeholders Affected
- Generic Drug Manufacturers: Benefit from clearer paths to approval but face new data submission burdens.
- Brand-Name Pharmaceutical Companies: May see reduced market exclusivity for drug-device products due to easier generic entry.
- Patients and Healthcare Providers: Primary beneficiaries through potential cost savings and improved access to treatments.
- FDA and Regulators: Must implement and enforce the updated evaluation standards.
Notable Legal, Constitutional, or Political Implications
- Legal: Strengthens the framework for generic approvals under the Federal Food, Drug, and Cosmetic Act by integrating device considerations, potentially reducing litigation over equivalence in combination products. No challenges to existing intellectual property or safety standards.
- Constitutional: No apparent issues, as the bill operates within Congress's authority to regulate interstate commerce and public health.
- Political: Promotes competition in pharmaceuticals, aligning with efforts to lower drug prices, but could face opposition from brand-name drug makers concerned about diminished protections for innovative devices.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Scholten, Hillary J. [D-MI-3]
Cosponsors (1)
Recent Actions
- 2025-09-04: Referred to the House Committee on Energy and Commerce.
- 2025-09-04: Introduced in House
- 2025-09-04: Introduced in House
Bill Versions
- Fair Price Device Act — issued 2025-09-04 — PDF (5 pages)