US FDA Center Directors Should Not Influence Adcomm Votes Or Overrule Scientific Staff, Coalition Says

20 Jul 2023

In a letter to Commissioner Robert Califf, the Patient, Consumer and Public Health Coalition says medical product center directors and other senior staff should refrain from trying to sway advisory committee votes and be reminded that overruling decisions of their own scientific staff undermines the public trust.

Hands — A coalition of nonprofit groups wants FDA product center directors to be more "hands off" when it comes to advisory committees and application approval decisions. • Source: Shutterstock

The US Food and Drug Administration should take steps to discourage its medical product center directors from influencing votes at advisory committee meetings and overruling review staff on product applications, a coalition of patient and consumer groups said.

In a 12 July letter to FDA Commissioner Robert Califf, members of the Patient, Consumer and Public Health Coalition...