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 personal risks, such as public hatred and death threats, encountered by ODAC chairs like Mikkael Sekeres and Maha H. Hussain during controversial drug review meetings. Despite these pressures, ODAC members remained focused on scientific evidence rather than public opinion. The document also discussed trends in drug development, noting a shift towards targeted therapies and the importance of confirmatory trials for accelerated approvals. The role of public hearings in ODAC meetings was emphasized as valuable, though sometimes influenced by drug sponsors. The session underscored the complexity of drug approval decisions and the need for objectivity and humility among ODAC members.