FDA’s commitment to the patient voice: one year of the Patient Affairs Staff

Feb 19, 2019
FDA’s commitment to the patient voice: one year of the Patient Affairs Staff

From holding dedicated “listening sessions” to creating health education videos, the Food and Drug Administration’s (FDA) Patient Affairs Staff has had a busy first year.

The department was set up in January 2018 to incorporate the patient voice in all aspects of the agency’s work.

“We believe patients are experts when it comes to their health conditions,” said Andrea C. Furia-Helms, MPH, Director of Patient Affairs Staff.

“They’re the ones who can share aspects of their diseases that even our most qualified doctors and scientists couldn’t possibly know. This valuable patient input is a critical part of our understanding of diseases and conditions that may help us to advance medical product development.”

The Patient Affairs Staff, which is part of the Office of the Commissioner, aims to “humanize the agency” by providing an “open door” from which to navigate the regulatory process, she added.

The FDA is listening

Since its inception, the department has developed forums designed to ensure the voices of patients, caregivers and patient advocacy groups are heard, explained Samir Shaikh, MBA, Deputy Director of the Patient Affairs Staff.

In partnership with the National Organization for Rare Disorders (NORD), for example, the agency has conducted listening sessions to learn more about rare diseases from patients, caregivers and advocates.

“We invite them to talk openly with the FDA review staff about living day-to-day with a rare disease or condition, giving us insight into their experiences,” explained Mr. Shaikh.

“This… provides a unique opportunity for the FDA to gain insight of patients’ perspectives on the burdens of a disease and its current treatments, as well as its impact on the patients’ and caregivers’ daily activities and quality of life.”

He went on to say that patient communities were welcome to request a listening session in their own area of interest.

Patients matter

Patient and advocate outreach is another area the department has been working in, with the launch of a new patient-facing webpage and video series called “Patients Matter”.

Mr. Shaikh said: “We are creating resources to help patients, caregivers, advocates and health professionals to connect with the FDA, making it easier for them to ask questions or request meetings about the FDA’s patient engagement, as well as to ask general questions about our regulatory processes.”

Looking to the year ahead, Mr. Shaikh said the Patient Affairs Staff would continue to build upon and launch patient engagement projects.

One such initiative, the Patient Engagement Collaborative, will seek to improve the quality and efficiency of clinical trials by working with patients and patient advocacy groups.

Set up in partnership with the Clinical Trials Transformation Initiative, the project will focus on enhancing patient engagement in product development and regulatory discussions.

Joint working

“As we move forward, we are energized by the relationships we’ve cultivated and the progress we are making,” said Mr. Shaikh.

“As patient populations and their needs evolve and become increasingly complex, we want patients and those who advocate on their behalf to know that our door is open. While our work will always be rooted in science, involving patients in identifying health priorities and outcomes is just as important.”

For more information on working with the FDA’s Patient Affairs Staff, click here.

FDA’s commitment to the patient voice: one year of the Patient Affairs Staff

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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