H.R. 2416

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a program to evaluate the potential use of evidence from clinical experience to support the approval of a new indication for an approved drug and to support post-approval study requirements.

"Evidence from clinical experience" means data from sources other than randomized clinical trials, including from observational studies, registries, and therapeutic use.

Before implementing the program, the FDA must establish a draft framework for the program that describes current sources of data from clinical experience, gaps in current data collection activities, standards and methodologies for collection and analysis of data from clinical experience, and priority areas, remaining challenges, and potential pilot opportunities that the program will address.

The FDA must use the program to inform guidance to industry on the collection and use of evidence from clinical experience.