§355g Utilizing Real World Evidence

Summary

The Secretary must set up a program to study using real-world evidence to help approve new uses for already approved drugs and to help meet postapproval study requirements. Real-world evidence means data about how a drug is used and its benefits or risks that come from places other than traditional clinical trials. Within 2 years after December 13, 2016, the Secretary must publish a draft plan showing data sources (like safety monitoring, observational studies, registries, claims, and patient-centered research), gaps in data, methods and standards for collecting and analyzing the data, and priority topics and possible pilot projects. The Secretary must consult with industry, researchers, medical groups, patient and consumer organizations, and others, using partnerships, contracts or grants, or public workshops. The program must begin within 3 years after December 13, 2016. The program must be used to make guidance for drug makers on when and how real-world evidence can be used and on proper collection and analysis methods. A draft guidance must be issued no later than 5 years after December 13, 2016, and a revised draft or final guidance must follow within 18 months after the public comment period ends. The Secretary may use real-world evidence for other purposes if there is a sufficient basis, but this does not change existing evidence standards or the Secretary’s power to require studies or trials.