US FDA Advisory Committee Reboot (Part II): The Right Balance For Conflicts Of Interest

29 Jun 2021

• By Kate Rawson

After back-and-forth tinkering with CoI restrictions, CDER is still finding it challenging to seat the right experts. Maybe more realistic guidelines are needed.

wooden balance beam — FDA WILL NEED TO BE NIMBLE TO BALANCE THE CONFLICTING DEMANDS ON ITS ADVISORY COMMITTEES • Source: Alamy

If a physician doses 10 patients with an investigational drug as part of a registrational trial, does that implicitly bias him for or against that product? If a medical professional with an expertise in a rare disease is a co-principal investigator, should that categorically exclude her from an advisory committee – even if she is one of the few global experts in that orphan condition?

Those are the types of questions that advisory committee consultant and 3D Communications Co-Founder Jim DiBiasi thinks the US Food...