Living as a patient with a chronic or rare disease is often isolating. And it can be difficult to get your voice heard.
That’s why the U.S. Food and Drug Administration (FDA) created Patient Listening Sessions, which are small, informal and non-public sessions that offer patients, caregivers and advocates the opportunity to connect with FDA staff first-hand. The goal is to provide an open forum for patients to share their lived experience with a disease to better inform medical and regulatory officials about what matters most to patients.
Listening sessions offer a sense liberation – the feeling of finally being heard, said Lynn Wilson, Vice President and Director of Patient Centered Research at the Myositis Support and Understanding advocacy organization. Wilson, lives with dermatomyositis, a rare condition that causes muscle weakness and skin changes.
“You can't imagine the impact that it has, because one of the things that we feel sometimes is that we're not being listened to by anybody, our family, our doctors, let alone the FDA,” Wilson said. “They don't know what we're going through.”
To make the best of talking to the FDA in one of these meetings Wilson offers three tips:
- Be prepared by getting familiar with the agenda, adhering to deadlines set by the FDA, knowing ahead of time who is going to share their story and what they’re going to say.
- Back up your presentation with research and data.
- Know that officials with the FDA and your patient organization are there to help with the process.
The listening sessions happen at the FDA’s request or because a patient group requests one. Being selected to participate gives patients a hopeful sense that their condition is important and deserving of attention.
“It’s a really uplifting moment for people to know that that are having an impact on their disease area by telling their story,” Wilson said.
Anne Rowzee, Associate Director for Policy at FDA’s Office of Tissues and Advanced Therapies, finds the sessions mutually impactful.
“It can be challenging to get a sense of these clinical manifestations and the patient burden, especially for rare diseases, without hearing directly from patients,” she said during a panel discussion at this year’s NORD Breakthrough Summit.
The FDA, responsible for overseeing approval of medical treatments, might not make any comments during a session, but that’s not the whole story. Rowzee said. Behind the scenes, a patient’s story might inform future therapy development, clinical trial design, or shape regulatory thinking, she said.
Interested in hosting one and having your voice heard by the FDA? You’ll have to apply, but most requests are granted, Rowzee said. And you don’t have to travel to Washington, D.C. for a session, said Robyn Bent, Patient Focused Drug Development Program Director at FDA’s Center for Drug Evaluation and Research (CDER). The agency also sets up sessions using Zoom. Upcoming sessions include sickle cell disease and C. difficile infections.