New FDA Advisory Committee to Develop Standards for Patient Engagement

Rigorous patient preference information should be part of the FDA’s process to determine risks and benefits of new products, Commissioner Scott Gottlieb said in a statement coinciding with the inaugural meeting of a new advisory committee on patient engagement.

The Patient Engagement Advisory Committee will be tasked with developing clearer ideas for the use of patient preference information in clinical trials, product design and regulatory decisionmaking, Gottlieb said. 

Rather than replacing relationships between the FDA’s product centers and patient organizations, the committee aims to expand those connections, he said.