Fair Price Device Act
Summary
The "Fair Price Device Act" (H.R. 5158) aims to amend the Federal Food, Drug, and Cosmetic Act, specifically concerning the approval process for combination products involving generic drugs and devices. The bill focuses on ensuring that generic drugs used with devices have the same clinical effect and safety profile as their brand-name counterparts. It directs the Secretary to determine appropriate changes due to device differences and requires additional information to support the equivalence of new drug-device combinations.
Expected Effects
This act is likely to streamline the approval process for generic drugs used with devices, potentially leading to lower healthcare costs. It will require manufacturers to provide more detailed information about the compatibility and performance of generic drugs when used with specific devices. This could also lead to increased scrutiny and potentially higher development costs for generic drug manufacturers.
Potential Benefits
- Potential reduction in healthcare costs due to increased availability of generic drug-device combinations.
- Enhanced patient safety through rigorous evaluation of generic drug-device compatibility.
- Streamlined regulatory pathways for generic drug approval, fostering innovation.
- Greater clarity and predictability in the approval process for manufacturers.
- Improved access to essential medicines for patients who rely on drug-device combinations.
Potential Disadvantages
- Increased regulatory burden and compliance costs for generic drug manufacturers.
- Potential delays in the approval of new generic drug-device combinations due to more stringent requirements.
- Possible legal challenges or disputes regarding the interpretation of "clinical effect and safety profile".
- May not fully address all potential differences between brand-name and generic devices.
- Could stifle innovation if the regulatory hurdles are too high for smaller manufacturers.
Constitutional Alignment
The bill appears to align with the Constitution's Article I, Section 8, which grants Congress the power to regulate commerce, including the regulation of drugs and devices. The bill aims to ensure the safety and efficacy of drugs, which falls under the government's responsibility to promote the general welfare. There are no apparent conflicts with individual rights or freedoms guaranteed by the Bill of Rights.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).