Fair Price Device Act

This bill updates how the FDA reviews generic medicines that must be used with a device. It sets clearer rules so a generic-plus-device can be approved if it’s expected to work the same and be just as safe as the brand-name drug when used with a device. It also allows the FDA to permit certain labeling changes when they are needed or appropriate because of device differences.

To support approval, companies may need to provide extra evidence about the device and how it works with the drug. This can include data on device performance and compatibility, how the drug is delivered when used with the device, comparisons of user interfaces, and studies of how people use the device. The FDA can deny approval if this information isn’t enough to show the same safety and effect as the original product.

• Who is affected: FDA reviewers; companies making generic drugs used with devices; patients who use drugs that require a device.
• What changes: More specific evidence may be required for approval; certain labeling differences are allowed when appropriate; FDA can reject applications that don’t show equal safety and effect with the device.
• When: The text provided does not state an effective date.