U.S. Food and Drug Administration Commissioner Scott Gottlieb during a meeting hosted by the National Health Council Friday stressed the importance of patient-reported outcomes and real-world evidence in the drug review and approval process, according to a MedPage Today report.
“If you want these things to be tangible, meaningful, and enduring, you have to build them into the process, you need guidance documents, you need to build them into the way information is received by the agency,” he said. “There has to be structure, there has to be consistency.”
Gottlieb said the agency is rolling out hundreds of disease-specific guidance, per the report, and that the FDA’s Center for Devices and Radiological Health has been looking at reshaping the benefits of some obesity devices based on patient feedback.
“Patients who were very obese were willing to assume a little more risk than … the agency had perceived,” he said.