FDA considering “Office of Patient Affairs” to help integrate patient voice into medical product regulation

Apr 13, 2017
FDA considering

The Food and Drug Administration (FDA) is considering the creation of an “Office of Patient Affairs” to help coordinate the integration of patient input into medical product regulation.

The idea is presented in a recently released Federal Register notice1 that is requesting comments on the new idea.

The new office would act as a single point-of-contact for patient advocacy groups to give their feedback on how medical products are regulated. A centralized structure will also help prevent duplication of patient engagement efforts.

“Engaging with patients, their caregivers, and advocates has long been a priority of the Agency,” says the FDA. “In this tradition, FDA intends to enhance future patient engagement by providing a more transparent, accessible, and robust experience for patient communities.

“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 notice specifically highlights key roles for the proposed office, including:
  • Offering a single, central entry point to the Agency for the patient community
  • Providing triage and navigation services for inbound inquiries from patient stakeholders
  • Hosting and maintaining robust data management systems that would incorporate and formalize knowledge shared with FDA by patient stakeholders and FDA’s relationships with patient communities
  • Developing a scalable and forward-looking platform for communicating with patient stakeholders, particularly online channels.

The new office would be the next step of the FDA’s Patient Focused Drug Development (PFDD), beyond its series of disease-specific meetings.

So far, the two dozen PFDD meetings have been praised for their importance in integrating patient voice into the pharmaceutical review process; however, the sheer number of different diseases makes it an unrealistic approach going forward.

In response, the FDA has gradually moved to encourage external groups to host their own patient feedback sessions, relaying ideal meeting structures to help draw as much actionable patient insight as possible from each meeting.

There is currently no clarification of whether the office will support or enable expanded access requests for treatments; however, recent legislation pushing for increased access to treatments for terminal conditions could make this a key office activity.

The new office would likely replace patient outreach efforts carried out by the Office of External Affairs and the Office of Health & Constituent Affairs – both replacements for the previous Office of Special Health Interests.


  1. FDA Register (2017) Enhancing Patient Engagement Efforts Across the Food and Drug Administration; Establishment of a Public Docket; Request for Comments. Available at: https://www.gpo.gov/fdsys/pkg/FR-2017-03-14/pdf/2017-04982.pdf (accessed March 2017).
FDA considering

Astellas Patient Advocacy is a function within Corporate Affairs at Astellas that focuses on creating, building and maintaining third-party relationships. We serve as a conduit between Astellas and external stakeholders to help improve patient outcomes, improve access issues and address patients’ unmet needs head on.

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