CTTI and the FDA recently announced newly selected representatives for the Patient Engagement Collaborative (PEC), a joint endeavor announced in December 2017 to gather members of the patient community to discuss new ways for patients and the FDA to work together. These 16 representatives will meet with the FDA several times a year to discuss topics such as communication, transparency, and how patients can participate in the FDA’s regulatory discussions about medical products.
The representatives are:
The representatives were selected from nearly 200 nominations received in response to a Federal Register notice published in December 2017. The selection committee, which included patient advocates and staff from CTTI and the FDA, worked to identify representatives with diverse perspectives and experiences who could meaningfully contribute and express the patient voice.
“We are excited to welcome these experts to the PEC and are confident that they will make a significant contribution to advancing patient engagement in research and development,” said Pamela Tenaerts, MD, MBA, CTTI Executive Director. “This group will play a critical role in ensuring that every step of medical product development accounts for patients’ needs.”
The PEC was created as a response to public feedback the FDA requested on Section 1137, Patient Participation in Medical Product Discussions, of the Food and Drug Administration Safety and Innovation Act (FDASIA). One suggestion was to create an outside group to give input on patient engagement across the FDA.