The National Health Council (NHC) and the U.S. Food and Drug Administration (FDA) have partnered with representatives from patient advocacy groups to compile a Patient Participation in Medical Product Discussions report.
Proposals in the report include the creation of a systematic approach to including patient preferences when regulatory decisions are made; more transparency about how patient input is weighed and made part of decisions; development of a defined method for patients organizations and the FDA to communicate; development of a tool to collect patients data that will organize information according to disease area and will lead to communication between FDA representatives and patient organizations; guidelines for drug sponsor involvement with patients and patient organizations as medical products are developed; and more forums for public and private health care stake holders.
“There is growing acknowledgement that patients can have important roles in the development of new drugs and treatments beyond their traditionally more passive role as research subjects,” NHC CEO Marc Boutin said. “The incorporation of patient input related to the outcomes that are most meaningful to the ultimate end users of medical products will aid in our shared goal of delivering high-quality medical care to people with chronic diseases and disabilities.”
The report was published Feb. 19.
“This report is the latest step in the agency’s effort to create regular, meaningful and predictable opportunities for patients to engage and to set expectations for the patient community regarding how those opportunities will ultimately inform FDA’s processes,” Boutin said.
