ARTICLE | Product Development

Preemptive on safety

September 12, 2005 7:00 AM UTC

Recent safety related drug withdrawals were not on the formal agendas at three FDA advisory committee meetings last week, but lessons about the importance of post-market surveillance to fully characterize safety played a prominent role in each meeting. Especially for drugs that will be used chronically, the meetings suggest that commitments to conduct post-market studies and physician education on a much larger scale than were expected in the pre-COX-2 era has become an unwritten but real prerequisite for approval.

"We are entering a new era in pharmaceutical development," one in which sponsors need to acknowledge that "with all new medicines, assessment of benefit and risk at the time of approval can only be an estimate," Brian Daniels, senior vice president of global clinical development at Bristol-Myers Squibb Co., said last Friday...