Patients Matter: Giving Patients a Seat at the Table

Patients Matter: Giving Patients a Seat at the Table


Picture a sunny
Tuesday in 1988. An ordinary work day
at the Food & Drug Administration. And then ACT-UP, the Aids
Coalition to Unleash Power, came knocking,
literally, at FDA’s door. The HIV/AIDS epidemic
was in its seventh year, ravaging communities
around the world. ACT UP wanted FDA’s help. Their voices were loud and
their need was so powerful that they helped us at
FDA look at disease in a different way – to
recognize that patients and their caregivers were
experts in their disease. They knew about aspects of
their diseases that our doctors and scientists
didn’t know, but we needed to know so we could find
the best ways to treat them. And it’s been that
way ever since. Over the years, we’ve
created multiple forums – “tables” at which
patients, caregivers, advocates and FDA staff
can sit and exchange ideas. These include
Patient-Focused Drug Development meetings,
public meetings organized by FDA on a specific
disease or health condition, where patients,
caregivers and advocates share their experiences of
living with the condition and burden of treatment
while FDA staff and other medical product
stakeholders listen and learn. FDA has hosted meetings
on more common conditions like psoriasis to rare
conditions like hereditary angioedema. We also hold Rare Disease
Listening Sessions, hosted in partnership with the
National Organization for Rare Disorders. These events, closed to
the public, focus on rare diseases in which little
is known, and effective treatments are even more
rare than the diseases themselves. During these listening
sessions, patients and their caregivers can speak
openly about what everyday life with a rare
disease is like. In turn, reviewers can see
that experience in a whole new light, better
understanding the patient’s needs as well as
the needs of the patient community. Then we have the FDA
Patient Representative Program. Before deciding to approve
a medical product, we often invite an advisory
committee of outside experts to review results
from clinical trials and other information on
already approved medical products with an eye
to regulatory policy. FDA currently has 47
advisory committees with 200 patient
representatives who serve as the voice for patients’
concerns on more than 300 conditions and diseases. They keep a human face on
the hundreds of pages of data that scientists
are asked to review. These representatives are
often asked to share their experiences and their
patient community’s experiences in meetings
between FDA and the companies developing
medical products. Another way for patients
to have a seat at the table is through our
Patient Engagement Advisory Committee
meetings. These are comprised
entirely of patients and caregivers who meet once
a year to advise FDA’s Center for Devices and
Radiological Health on issues related to medical
devices – everything from hearing aids to pacemakers
– and the needs and concerns of those
who use them. Patients and caregivers
can attend the meetings in person to contribute their
experiences and views or they can listen via
teleconference. And then there’s the
Patient Engagement Collaborative, created
in partnership with the Clinical Trials
Transformation Initiative at Duke University. Its goal is to find better
ways of reaching out to patients, understanding
what their needs are to better educate them on how
decisions are made and how they can contribute to
the discussions affecting their health. Each one of these forums
provides patients, caregivers and advocates
with a seat next to FDA scientists, doctors
and researchers. Their input is invaluable,
influencing our decision-making
across the agency. Would you like a
seat at the table? We hope so! Please contact FDA’s
Patient Affairs Staff. Thank you.

Leave a Reply

Your email address will not be published. Required fields are marked *