FDA Considers Creating New 'Office of Patient Affairs'

As part of efforts to better capture patients' perspectives, the US Food and Drug Administration (FDA) on Monday said it is considering establishing an "Office of Patient Affairs," to be tasked with supporting and coordinating patient engagement across the agency.

The move to create the office would be part of the agency’s efforts to offer “a single, central entry point to the Agency for the patient community,” as well as “triage and navigation services for inbound inquiries from patient stakeholders.”

The office would likely host and maintain data management systems to incorporate and formalize knowledge shared with FDA by patient stakeholders and FDA's relationships with patient communities, and the office would be part of efforts to develop a scalable and forward-looking platform for communicating with patient stakeholders, particularly online.

Background

FDA currently has an Office of Health and Constituent Affairs that includes a patient team, as well as a FDA Patient Representative Program, managed by the same office and that participates in advisory committee hearings for new medical products and review division meetings and workshops.

The idea to create this new office, according to FDA, was directly informed by feedback solicited through stakeholder engagements outlined under the Food and Drug Administration Safety and Innovation Act (FDASIA).

In addition to the Office of the Commissioner launching an effort to enhance mechanisms for patient engagement at FDA, FDA and the European Medicines Agency last summer began exchanging more information on the best practices of involving patients, and FDA’s Center for Devices and Radiological Health in September 2015 established the first-ever Patient Engagement Advisory Committee (PEAC) to ensure patient needs and experiences are included during the review of medical devices.

Federal Register