Location: FDA White Oak Campus, Silver Spring, MD-Building 1, Great Room
FDA attendees: Robert Califf (Commissioner, virtual due to exposure to viruses), Peter Marks (Director, CBER, virtual), Owen Faris (OPEQ Principal Deputy Director, CDRH, virtual); In person: Julia Tierney (Chief of Staff, Office of the Commissioner), Jacqueline Corrigan-Curay, (Principal Deputy Director, CDER), Dayle Cristinizio (Director, Stakeholder Engagement, Office of External Affairs), Hilary Maston (Chief Medical Officer), Namandje Bumpus (Chief Scientist, AdCom responsibilities), Kaveeta Vasisht (Assoc Commissioner for Women’s Health), Jennifer Dooren (Director Communications and Public Engagement, Food Safety).
Coalition Attendees: In Person: Thomas Eagen (NCHR), Maria Gmitro (BISA), Denise Hyater-Lindenmuth (NWHN), Patricia Kelmar (U.S. PIRG), Suzanne Robotti (MedShadow), Kim Witczak (WoodyMatters), Diana Zuckerman (NCHR). Virtual: Tahir Amin (I-MAK), Wendy Dolin (MISSD), Helen Haskell (MAME), Rex Johnson (WAPS), Katherine Leon (SCAD Alliance), Judy Norsigan (OBOS), Linda Radach (PSAN), Reshma Ramachandran (DFA), Brian Ronholm (Consumer Reports), Tess Schulman (Medical Device Problems), Robin Strongin (NCL), Dru West (USAPN), Sophia Phillips (on behalf of the Coalition).
On behalf of the Coalition members at the meeting, Dr. Diana Zuckerman offered our support to the Commissioner and the FDA, and thanked the Commissioner for his efforts to improve the Accelerated Approval program by requiring confirmatory trials be started prior to granting accelerated approval. Patricia Kelmar discussed members’ support for the FDA to regulate lab-developed tests to ensure their accuracy. Kim Witczak and Suzanne Robotti discussed possible improvements to the FDA Advisory Committee process, based on their perspectives as consumer representatives on two FDA Advisory Committees. After the meeting was completed, Coalition members who were attending in person had informal discussions with several FDA officials.