H.R. 5158 — Fair Price Device Act

This section revises the requirements under the abbreviated new drug application (ANDA) pathway for generic drugs intended for use with a device (e.g., auto-injectors or inhalers). (1) In ANDA content requirements, it expands exceptions for differences in inactive ingredients, labeling, and packaging to include those "required or appropriate, as determined by the Secretary" (from "required"), explicitly including differences from otherwise permitted changes such as in the device; and adds a new requirement for relevant information—beyond standard ANDA data—to demonstrate the generic drug with its device has the same clinical effect and safety profile as the listed drug with its device under labeled conditions, which may include device compatibility and performance data, comparative analyses of user interfaces, and human factors studies. (2) In criteria for deeming ANDA drugs therapeutically equivalent to the listed drug, it makes parallel expansions to inactive ingredient/labeling/packaging exceptions; adds a new basis for denial if submitted information is insufficient to show the required sameness for device-using drugs; and makes conforming redesignations.