The FDA Patient & Caregiver Connection: Impacting Innovations in Patient Care and Treatment

As an extension of AAKP’s National Strategy, AAKP participates in key initiatives that allow us to engage kidney patients in substantive and meaningful efforts designed to impact research over the long-term and help lead to new innovations for medical devices (including diagnostics), drugs and biologics for the diagnosis and treatment of kidney diseases.   

Through the AAKP Center for Patient Research & Education, AAKP leadership and members are highly supportive of the work of the U.S. Food & Drug Administration (FDA) and the FDA Patient & Caregiver Connection (P&CC) initiative.  AAKP’s relationship with the FDA is similar to our fifty year relationship with the Centers for Medicare and Medicaid Services – we work together to make certain the patient perspective is represented across the development and evaluation of new, safe treatments and the accessibility of those treatments among the ever widening pool of kidney patient consumers and the medical professionals who care for them. 

What is the FDA Patient & Caregiver Connection (P&CC)? 

In 2018, the FDA established the P&CC to provide the Center for Devices and Radiological Health (CDRH) with a formal process to obtain patient and caregiver input. AAKP is proud to have been invited by the FDA to be an original partner in this connection since inception and represents the only kidney-related organization within the connection.   

The development of this program is part of CDRH’s Patient Science and Engagement Program aimed at fostering engagement with patients, caregivers, and patient advocates throughout the development, evaluation, and surveillance of medical devices. The P&CC aims to partner with patient organizations across various disease communities to provide a means for gaining insights from patients and caregivers about their experiences living with their disease(s) as well as experiences with medical devices intended to diagnose and treat their medical conditions.  

How important is the P&CC role in the FDA? 

Very!  CDRH works with both patients and caregivers to advance the development and evaluation of innovative medical devices and monitor the performance of marketed devices. P&CC partnerships enable a culture of meaningful patient engagement and interaction between CDRH staff, patients, and caregivers. 

Engaging with patients and caregivers through the P&CC enhances CDRH's ability to hear, understand, and integrate their unique and important perspectives in the course of its work to help advance and improve public health. 

“The FDA values the contribution of patients working as partners giving the agency additional insights on what technological innovations would best meet their needs,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. 

In 2019, the CDRH hosted their first P&CC community town hall at their White Oak campus headquarters in Silver Spring, Maryland.  Dr. Jeffrey Shuren, Director of CDRH kicked off the meeting with a message about the critical importance of stakeholder relationships to the FDA, the key role patient consumer perspectives have within the deliberative process at FDA and the high value the work of the CDRH’s Patient Science and Engagement Program has for both FDA and patients. The event was widely attended by FDA professionals, who engaged directly with patients and partner organizations to learn more about their missions and capacities. FDA was pleased to have AAKP’s Executive Director Diana Clynes and Chair of Policy and Global Affairs Paul Conway actively participate in this inaugural event. 

How does the P&CC work? 

When CDRH staff are seeking the perspectives of  patients to help inform their work at the Center, they can reach out to the Patient and Caregiver Connection who then turn to AAKP and fellow partner organizations who are part of this connection to obtain the needed patient and caregiver feedback. Partner organizations, like AAKP, the only kidney-related organization in this connection, disseminate questions or surveys to their membership and collect responses. Most surveys focus on the following topics: 

  • Patients' experiences living with their specific condition 
  • Patients' experiences with devices used for the diagnosis, treatment or management of their condition 
  • Current issues or trends related to medical devices that they use or may be treated with 

AAKP and fellow partner organizations aggregate the responses and share with CDRH, assuring no personally identifying information is included. The feedback obtained is so important as it provides broader context and a better understanding of the patient experience for CDRH staff to consider throughout the course of their work. 

AAKP sends out these online survey opportunities as Action Alerts to its membership and shares across its robust social media and online platforms. We encourage you to take a few minutes when these alerts are sent out to share YOUR thoughts, expertise and opinions – they are so very important to making sure the patient voice is HEARD and included in the development of products and devices intended to improve patient care and expand patient choice.  The professionals at the FDA welcome and need kidney patient consumer feedback and AAKP makes it a top priority to honor the opportunity and our responsibility as a partner organization. 

COVID-19 Supplies, Device and Access Impact Survey - May 2020 

In May 2020, nearly 300 members of the AAKP, completed a survey to inform the U.S. Food and Drug Administration (FDA) about dialysis device-related concerns.  Survey responses helped the FDA to assess possible challenges kidney patients were having accessing supplies, devices and services. This information was used to help inform CDRH’s response efforts to address device shortages.  

  

Meet the Partner Organizations of the Patient & Caregiver Connection! 

American Association of Kidney Patients 

American Sleep Apnea Association 

COPD Foundation 

Faces and Voices of Recovery 

Facing our Risk of Cancer Empowered 

Global Healthy Living Foundation 

International Children’s Advisory Network 

JDRF International 

Mended Hearts 

The Michael J. Fox Foundation 

Muscular Dystrophy Association 

National Alliance for Caregiving 

National Organization for Rare Diseases 

North American Spinal Cord Injury Consortium 

TMJ Association 

Learn more at https://www.fda.gov/about-fda/cdrh-patient-engagement/cdrh-patient-and-caregiver-connection.