In seeking guidance on how to improve the regulatory process to enable access to much-needed treatments, who better to listen to than patients and caregivers? They are the stakeholders with the greatest understanding of which therapeutic solutions will help them manage their symptoms and improve their quality of life. With this in mind, the US Food and Drug Administration has developed several programs to encourage the patient voice in drug development and healthcare.

Patient Listening Sessions

Hosted by the FDA’s Office of Patient Affairs (OPA), together with the National Organization for Rare Disorders (NORD) and the Reagan-Udall Foundation, Patient Listening Sessions are small and informal conversations that bring patients/caregivers and researchers together. These sessions are aimed at complementing the FDA’s existing patient engagement initiatives.

The agency has been conducting listening sessions since 2018, with a focus on disease experience rather than a particular medical drug, biologic, or device. Thus, only patients, caregivers, patient advocates and staff of FDA Centers and programs are generally allowed to participate.

For FDA medical product staff, Patient Listening Sessions are a resource for directly hearing from patients about their disease experience and gaining a view of the patient and caregiver perspectives. For the patient/caregiver, they are an opportunity to share their stories freely, advocate for patient needs and directly educate regulatory decision-making.