Rather than rehashing the debate, let’s just say (1) this decision wasn’t a surprise and (2) it’s a missed opportunity for advancing regulatory science.
Regardless of where you stand on Avastin for HER2-negative metastatic breast cancer – this was a “teaching moment” for the FDA. And the agency missed it.
Specifically, it was an opportunity for the FDA to talk about the future of molecular diagnostics and how it wants to be a partner with industry in their development. Peggy & Co. should have taken the opportunity to go beyond communicating a specific regulatory decision and seized a leadership position on a crucial healthcare policy issue. This is even more disappointing considering the high profile the agency has given recently (and appropriately so) to its Advancing Regulatory Science Initiative (ARSI).