Fair Price Device Act

The Fair Price Device Act would modify how the FDA evaluates generic drugs intended for use with medical devices (i.e., combination products). It adds a new, explicit requirement that when a listed drug is meant to be used with a device, the application for a generic version must include information showing that the generic-drug-with-device can be expected to have the same clinical effect and safety profile as the listed drug-with-device. This new information can cover device performance, how the drug is delivered with the device, compatibility between the drug and device, and human factors (how patients interact with the device and drug). The bill also broadens the types of changes that may be considered appropriate or required due to differences between the device and the generic-drug-device combination. In short, the bill tightens and broadens the data the FDA must review to approve generics for device-combination products, with a focus on ensuring equivalent clinical effect and safety.