The rules of patient engagement are still being drawn up. The FDA is now considering the creation of an Office of Patient Affairs, that would focuson soliciting the perspectives of patients and taking those insights into account as it sets regulatory policy.
The agency wants to learn about patients’ attitude toward the risk-benefit balance for new drugs and devices, wants to better understand how to most effectively solicit patient input, and wants to explore how to best support patients and their advocates in their efforts to understand regulation.
‘To achieve these objectives, the Agency is considering establishing a central ‘Office of Patient Affairs’ which will be tasked with supporting and coordinating patient engagement activities across medical product centers and other offices that engage with patients and their advocates on matters pertaining to medical products,’ the FDA writes in the Federal Register.
