ODAC Chairs Reveal Challenges, High Drama in a Decade of Service

The document detailed the challenges and intense experiences faced by members of the Oncologic Drugs Advisory Committee (ODAC) of the FDA over a decade. It highlighted the public scrutiny and pressure they endured, such as during the controversial review of bevacizumab for metastatic breast cancer, which led to public outcry and personal threats. Despite these challenges, ODAC members remained focused on scientific evidence rather than public pressure. The document also discussed trends in drug development, noting a shift towards targeted therapies and the importance of confirmatory trials for drugs approved under accelerated approval. The discussions emphasized the complexity of drug approval decisions and the need for objectivity, despite inherent biases from personal experiences.