Thursday, December 16, 2021

Brief Blog: FDA Headlines: 5 Issues for FDA; Califf at Congress; "Chaos" in Checkpoint Inhibitors

Flurry of headlines about the FDA.

  • At Endpoints, Zachary Brennan highlights five issues for  FDA, as it prepares for a new leader after a year without one.  Here.
    • Accelerated approvals - are they too low a bar?
    • Real world evidence - how to really use it? (e.g. for just 1 resource, here).
    • COVID - from boosters to medications to backlog
    • Hiring and retention
    • Opioid epidemic; ongoing issues
  • Robert Califf MD, who led the FDA under Obama, and most recently had a leadership role at Veriliy, on the Hill for confirmation hearings.  
    • Story at Government Executive, here.
  • Cancer leadership at FDA, including Richard Pazdur, describe a chaotic world of me-too checkpoint inhibitor drugs.
    • See a news story at Endpoints here.
    • See the new op ed "Wild West" at NEJM here.
Everyone who works at the intersection of diagnostics and oncology knows that better checkpoint inhibitor biomarkers are badly needed.  Some markers appear to work well in large meta-analyses yet have little clinical traction (here).