Accelerated Approval Under Pressure: What’s At Stake and What Can Be Done?
10:45 AM - 12:00 PM (EDT), Wednesday, June 7, 2023 ・ Session Room 205ABC
The success of the Accelerated Approval pathway has meant countless patients received access to needed therapies much sooner, with close to 300 treatments having been approved on average more than three years earlier than they would have otherwise. However, a lack of understanding and some calculated misrepresentations have contributed to relentless scrutiny of this pathway, one that is critical for patients such as those living with rare diseases, cancer, HIV, and other serious conditions. In an era when patient-industry collaboration continues to grow and optimism should rule the day, Accelerated Approval faces increasing pressure at every turn. This session will feature a cross-section of leaders who will discuss the intent and impact of Accelerated Approval, explore the current serious policy and regulatory issues facing all stakeholders, and share promising research which could be a springboard to collective action to protect and strengthen this critical pathway.