Bill > HR5158

This bill amends the Federal Food, Drug, and Cosmetic Act to establish new requirements for approving generic drugs that are used in combination with medical devices. Specifically, the bill requires additional submission of information when a generic drug is intended to be used with a device, including comparative data about the device's performance, compatibility, user interface, and human factors studies. The goal is to ensure that generic drugs used with devices can be expected to have the same clinical effect and safety profile as the original listed drug when used with its corresponding device. The bill allows the Secretary of Health and Human Services to determine what specific information is relevant and appropriate for evaluating these combination products. The changes are designed to provide more comprehensive review of generic drugs that are used in conjunction with medical devices, potentially improving patient safety by ensuring thorough evaluation of how the drug and device work together. The bill is titled the "Fair Price Device Act" and modifies existing provisions in Section 505(j) of the Federal Food, Drug, and Cosmetic Act related to generic drug approvals.

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https://www.congress.gov/bill/119th-congress/house-bill/5158/all-info