In the March 14, 2017 Federal Register, the Food and Drug Administration (“FDA”) announced that it is considering establishing a new Office of Patient Affairs (“Office”). This consideration results from FDA’s intention to “enhance future patient engagement by providing a more transparent, accessible, and robust experience for patient communities.”[1] The Federal Register notice outlined FDA’s proposal for such future patient engagement, which aims to better capture the perspectives of patient communities.

Recognizing the importance of engaging with patients, caregivers, and their advocates in the medical product development process, Section 1137 of the Food and Drug Administration Safety and Innovation Act (“FDASIA”), Patient Participation in Medical Product Discussions, directs the Secretary of Health and Human Services to “develop and implement strategies to solicit the view of patients during the medical product development process and consider the perspectives of patients during regulatory discussions.” In response to public comments the agency received on Section 1137, the FDA initiated an effort to increase patient engagement activities, involving the following objectives:

  • Develop a better understanding of the patient experience of disease by:
    • gathering patient perspective on what is clinically meaningful;
    • assessing attitudes towards benefit-risk and tolerance of uncertainty; and
    • enhancing the science of eliciting and integrating patient input.
  • Support patients and their advocates in understanding regulatory processes and navigating the FDA by:
    • communicating relevant FDA positions, procedures and activities;
    • connecting patients and their advocates with the appropriate resources; and
    • resolving discrete challenges and needs.[2]

To achieve these objectives, FDA is weighing the creation of the Office. The centralized Office will support and coordinate engagement activities with patients and their advocates in medical product centers and other relevant locations. The proposed responsibilities of the Office include:

  • Offering a single, central entry point to FDA 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; and
  • Developing a scalable and forward-looking platform for communicating with patient stakeholders, particularly online channels.[3]

FDA proposes clear governance structures to ensure direct accountability of the Office to the medical product centers, as well as regular evaluation of the Office and FDA’s overall patient engagement efforts. This evaluation process would involve soliciting feedback from external stakeholders, including patients and their advocates, on a biennial basis.

Comments on the proposed new Office are requested by June 12, 2017 and may be submitted electronically via the Federal eRulemaking Portal or as written/paper submissions via mail/hand delivery/courier to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Confidential submissions will be accepted as written/paper submissions in the manner detailed and will not be made publicly available.