ACT-AD Presents at FDA Inaugural Patient Network Annual Meeting

The Food and Drug Administration’s (FDA) Office of Special Health Issues (OSHI) in collaboration with the Center for Drug Evaluation and Research (CDER), Center for Biologic Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH), holds an Inaugural Patient Network Annual Meeting. The meeting, titled Patient Input into FDA Benefit-Risk Decision-Making: Opportunities and Challenges, was convened to discuss opportunities for FDA to enhance its regulatory decision-making, through the inclusion of patients and patient advocate groups during benefit-risk assessments of drugs and devices.


ACT-AD Coordinator Cynthia Bens presents on a patient panel during the meeting. Ms. Bens’ remarks stress the importance of considering disease severity and unmet need in FDA’s risk/benefit decision-making on early stage treatments for Alzheimer’s. Ms. Bens also highlights that for chronic, progressive diseases like Alzheimer’s the views of caregivers on benefit and risk must be taken into account along with patient reports at every phase of the regulatory process.