Fair Price Device Act

This bill changes federal drug law on how the Food and Drug Administration approves generic versions of drugs that are used with a device, such as an inhaler or injector pen. Generic applicants would have to submit information showing that their drug, used with its device, can be expected to have the same clinical effect and safety profile as the brand-name drug used with its device. This information may include device performance data, comparisons of the user interface, and human factors studies. The bill would also let the generic's labeling differ from the brand-name labeling where the Secretary finds changes appropriate because of differences in the device. The Secretary would be required to refuse approval if the submitted information is not enough to show the same clinical effect and safety profile.

Full text and official record on Congress.gov

Sponsors

• Hillary J. Scholten Democrat sponsor
• 1 cosponsors