The FDA’s Office of Patient Affairs Shares Highlights from 2021 Programs and Encourages you to Participate in their Upcoming 2022 Activities.

The United States Food and Drug Administration’s Office of Patient Affairs is sharing recent highlights with the public from 2021 and is encouraging people to participate in their 2022 activities. Following is their statement:

COVID-19 response

Throughout the year, we worked closely with others from across the FDA to keep patients, caregivers and advocates updated about the COVID-19 pandemic and the latest scientific developments. When the pandemic began, we created a COVID-19 webpage with resources specifically for patients. We continue to update it regularly and encourage you to check it out.

FDA Patient Listening Session Program

In 2021, Patient Affairs surpassed the previous year’s record by organizing and leading 18 Patient Listening Sessions. FDA staff learned more about health-related experiences, perspectives and needs that are most important to patients, caregivers, advocates and community representatives. We published an article in American Academy of Pediatrics (AAP) News about our first Patient Listening Session with only adolescent participants. During the session, a small group of transgender adolescents (ages 13 through 17) shared their unique health care challenges and unmet medical needs related to hormone and hormone-blocking therapies.

FDA Patient Listening Sessions give patients an opportunity to share their experiences with FDA to help us better understand what is most important to patients. These sessions focus on patient experiences, perspectives and needs related to their health. We encourage you to learn more about the program and read summaries of previous Patient Listening Sessions. Please use this form if you are interested in submitting a request for a Patient Listening Session.

Patient Engagement Collaborative

We received more than 100 applications in response to a Federal Register notice for new Patient Engagement Collaborative (PEC) members. The selection committee, which included patient advocates, FDA staff, CTTI staff and several outgoing PEC members, reviewed applications and identified eight new members with diverse perspectives and experiences who could meaningfully contribute and express the patient voice. In December 2021, we virtually held an introductory PEC meeting with new and continuing members, and we look forward to continuing our collaboration with the PEC this year. The PEC is a partnership between the FDA and the Clinical Trials Transformation Initiative (CTTI). The members of the PEC discuss ways to enhance patient engagement in medical product development and regulatory discussions at the FDA.

The patients, caregivers and advocate members of the PEC continued their work in patient communication and education. They provided valuable ideas and insights into our About FDA: Patient Q&A document to assist with clarifying the FDA’s role and helping patients understand regulatory terms. The Q&A is downloadable and written in easy-to-understand language.

Additionally, the PEC participated in an inaugural meeting with the European Medicines Agency (EMA)’s Patients’ and Consumers’ Working Party to exchange ideas around enhancing patient engagement, particularly with incorporating youth perspectives. This was a great collaboration and we plan to meet annually.

Patient Affairs continued to lead internal FDA initiatives to benefit patients, caregivers and advocates. We met regularly with the EMA and Health Canada through the Patient Engagement Cluster to exchange information, share ideas, and learn from one another. We also regularly organized a group of staff across the FDA, known as the Patient Council, to collaborate and discuss cross-cutting patient needs. Also, FDA’s Rare Disease Day 2022 (virtual) is March 4, 2022. Please save the date. Registration will be coming soon.

We are grateful for the opportunity to collaborate with the National Organization for Rare Disorders (NORD), the Reagan Udall Foundation for the FDA, EMA and CTTI.

Finally, we encourage patients, caregivers and advocates to continue to stay connected to us.

Patients and caregivers are the heart of our public health mission, and we thank you for sharing your perspectives and experiences with us. Thank you for all that you do. We look forward to working with you in 2022.

Patient Affairs

Office of Clinical Policy and Programs
Office of the Commissioner
U.S. Food and Drug Administration
Tel: 301-796-8460

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